2001 transcatheter cardiovascular therapeutics

THURSDAY 9/13/01 9:00 –10:00

2001 TRANSCATHETER CARDIOVASCULAR THERAPEUTICS Poster Abstract Presentations All Poster Abstracts will be presented in the Main Lobby at the following times: Thursday, September 13, 2001 9:00 –10:00 AM 3:00 – 4:00 PM Friday, September 14, 2001 9:00 –10:00 AM 3:00 – 4:00 PM All Poster Abstracts will also be available for viewing in the Main Lobby at the following times:

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Thursday, September 13, 2001 8:00 AM– 6:00 PM Friday, September 14, 2001 8:00 AM– 6:00 PM

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in native coronary arteries, but little is know about short- and long-term follow-up at the site of the temporary distal occlusion balloon. Methods: We performed quantitative coronary angiography (QCA) analysis of the vascular region after final deflation of the GuardWire (PercuSurge, Sunnyvale, CA) distal protection balloon (day 1) and compared the identical region in patients (pts) who underwent recatheterization (day 2). Cumulated inflation time (mean, 14.2 ⫾ 12.4 minutes; range, 2.1 to 59 minutes), number of inflations, and maximal size of the distal balloon were included in the analysis. Results: Among the 335 pts with GuardWire-assisted PCI from our institution, we identified 37 pts (mean age 59 ⫾ 11 years, 11 women; left anterior descending [n ⫽ 18], right coronary artery [n ⫽ 16], and left circumflex [n ⫽ 3]) who were restudied 108 ⫾ 126 days (range, 1 to 425 days) after PCI because of reinfarction (n ⫽ 7) or infarction (n ⫽ 1), acute coronary syndromes (n ⫽ 12), elective study (n ⫽ 9), or for other reasons (n ⫽ 8). Acutely the temporary low pressure inflation balloon did not induce any local changes on day 1 in all pts. Similarly, on day 2 there were no changes, and minimal lumen diameter at the former site of the inflation was identical (2.7 ⫾ 8.3 and 2.6 ⫾ 8.3 mm; ranges, 1.61 to 5.11 and 1.55 to 4.75 mm, respectively) and did not cause any stenosis. The number and time of inflations and size of the balloon did not have any influence. Conclusion: From this preliminary study it seems that a low pressure inflation distal protection device does not cause any harm to the vascular bed.

TCT-84 Is Adjunctive Balloon Post-Dilatation Necessary After Coronary Stent Deployment? Final Results From The POSTIT Trial. B. Brodie1, C. Cooper2, M. Jones3, P. Fitzgerald4, A. Medhkour5, F. Cummins6. 1LeBauer Cardiovascular Research Foundation, Greensboro, North Carolina, USA; 2Medical College of Ohio, Toledo, Ohio, USA; 3Central Baptist Hospital, Lexington, Kentucky, USA; 4Stanford University Medical Center, Stanford, California, USA; 5Boston Scientific Scimed, Minneapolis, Minnesota, USA; 6St. Luke’s Medical Center, Milwaukee, Wisconsin, USA.

Background: Low pressure inflation has not been reported to cause adverse local effects during percutaneous coronary intervention (PCI)

Background: Minimal stent area (MSA) and minimal lumen diameter (MLD) after stent deployment are strong predictors of late restenosis and target vessel revascularization. The need for adjunctive balloon post-dilatation for obtaining optimal stent deployment in patients undergoing elective coronary stenting with modern stent delivery systems is unknown. Methods: Patients undergoing elective stenting were randomized to NIR (n ⫽ 166) or other stents (n ⫽ 158; ACS Tristar/Tetra, AVE S670). Intravenous ultrasound (IVUS) measurements were performed immediately after stent deployment. The primary endpoint was defined as an in-stent MLD ⱖ90% of the average reference lumen diameter by IVUS immediately following stent deployment. If, by operator assessment, the primary endpoint was not achieved with the stent delivery system, adjunctive balloon post-dilatation was performed. Core IVUS lab measurements were performed in 257 patients. Results: IVUS-guided adjunctive balloon post-dilatation was performed by operator assessment in 60% of all patients. Lesion complexity predicted the use of post-dilatation (72% of type B2/C vs 54% type A/B1 lesions, p ⫽ 0.005). By core lab analysis, only 30% of patients achieved the primary endpoint without post-dilatation. In patients undergoing post-dilatation, MSA increased from 6.6 ⫾ 2.2 mm2 after the use of the stent delivery system to 7.8 ⫾ 2.3 mm2 after adjunctive

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Coronary Interventions: Distal Embolic Protection and Advanced Stent Techniques (Abstract nos. 83–125)

TCT-83 No Angiographic Evidence of Harm to Native Coronary Arteries Using the GuardWire Distal Embolization Protection Device. G. Su¨tsch, G. Puippe, M. Kessel, W. Kiowski, F.W. Amann, University Hospital, Zurich, Switzerland.

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balloon dilatation (p ⬍0.0001). MLD increased from 2.56 ⫾ 0.45 to 2.76 ⫾ 0.44 mm. There were no differences in outcomes between the 2 stent groups. Conclusion: With current stent delivery systems, optimal stent deployment is achieved in only 30% of patients. Complex lesions require post-dilatation more frequently than simpler lesions. The use of adjunctive balloon post-dilatation significantly improves MSA and MLD and the frequency of achieving optimum stent deployment. Data from POSTIT stresses the continued need for adjunctive balloon dilatation with modern stent delivery systems.

TCT-85 Late Clinical Outcome After Extensive Stent Implantation in Native Coronary Arteries. M.R. Le May, A. Pronovost, M. Labinaz, E. O’Brien, R.F. Davies, C. Glover, P. Doucette, A. Feres. University of Ottawa Heart Institute, Ottawa, Ontario, Canada. Background: Extensive stenting of native coronary arteries is feasible, but there are limited data on late follow-up. This study evaluated the clinical experience of extensive stenting at our center. Methods: Between January 1999 and November 2000, 2,753 percutaneous coronary interventions were performed at the University of Ottawa Heart Institute. Of these, successful deployment of ⱖ40 mm of stent in native coronary arteries was performed in 185 patients (pts). Intravascular ultrasound was not used routinely. We excluded pts with previous coronary artery bypass graft (CABG), percutaneous transluminal coronary angiography (PTCA) within 6 months, staged PTCA procedures, and cardiogenic shock. Follow-up was conducted by hospital and clinic chart review, and by telephone calls. Results: Mean age was 60 ⫾ 11 years, and men accounted for 74% of pts. Cause of presentation was as follows: acute coronary syndromes, 50%; ST-elevation acute myocardial infarction (AMI), 6%; post-AMI angina, 21%; unstable angina, 23%. Risk factors included: diabetes (19%), hyperlipidemia (66%), hypertension (41%), and smoking (35%). A history of previous AMI was obtained in 33% of pts. On average, 2.94 ⫾ 0.96 stents were deployed per patient, with an average total length of 53.5 mm (range, 40 to 131mm). Stenting was performed in a single coronary artery in 58% of pts, 2 coronary arteries in 36%, and 3 coronary arteries in 6%. Antiplatelet therapy with aspirin and a thienopyridine (ticlopidine or clopidogrel) was prescribed to all pts. Platelet glycoprotein IIb/IIIa receptor inhibitors were used in 48% of pts. Follow-up was obtained in 99.5% of pts at a mean of 14.7 ⫾ 7.7 months. Events captured were: death, 9 pts (4.9%); AMI, 9 pts (4.9%); CABG, 9 pts (4.9%); repeat PTCA, 17 pts (9.2%). Repeat angiography for symptoms was performed in 31 pts, 15 of whom had in-stent restenosis. Event-free survival (free from death, AMI, CABG, or PTCA) was observed in 83% of pts. At follow-up, 19% of survivors had Canadian Cardiovascular Society class I–II angina and 74% were asymptomatic. Conclusion: In selected pts, extensive stenting of native coronary arteries without the use of routine intravascular ultrasound, results in satisfactory late clinical outcomes.

TCT-86 Percutaneous Coronary Interventions in Patients with Severe Left Ventricular Dysfunction: Short- and Long-Term Outcomes. B.F. Hayerizadeh1, M. Galinier2, J. Fourcade2, F. Richez2, L. Schmutz2, I. Bossi1, J. Fajadet1, J.M. Fauvel2, J. Puel2, J.P.

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Bonhoure2, J. Marco1. 1Unite´ de Cardiologie, Clinique Pasteur, Toulouse, France; 2Fe´de´ration des Services de Cardiologie, Hoˆpitaux de Toulouse, Toulouse, France. Background: Left ventricular (LV) function is known as the main predictive factor for survival in coronary patients and the results of coronary bypass surgery in LV dysfunction have been well documented. Data regarding the outcome of percutaneous interventions in this group are limited. Using recent data, we sought to assess the outcome of patients with severe LV dysfunction (ⱕ35%) who were referred for percutaneous coronary interventions (PCI). Methods: From May 1995 to March 2000, 387 procedures were performed in 363 patients (15.2% women; mean age, 68.2 years). Acute (⬍24 hours) myocardial infarction (MI) or hemodynamically unstable patients were excluded. Mean LV ejection fraction was 0.297 ⫾ 0.05. New York Heart Association class III/IV was reported in 21% and unstable angina in 32%. Comorbidities included previous MI (60%), previous coronary artery bypass graft (24%), diabetes (27%), peripheral arteriopathy (16%), multivessel disease (78%); 57% of patients had at least 1 major vessel occlusion. Overall, 604 lesions were treated (47% stented). Clinical follow-up was completed for 96% of patients. Mean follow-up time was 27.4 ⫾ 18.4 (median, 24.6) months. Results: Procedural success was 94.3%. The 30-day survival rate was 97%; 30-day major cardiac events (death, Q-wave MI, and revascularization) were seen in 5.9%. Overall survival was 90%, 82%, 74%, 68%, and 54% at 1, 2, 3,4, and 5 years, respectively. Median (50%) MI/revascularization-free survival was 48.5 ⫾ 3.1 months, whereas median survival without hospitalization for unstable angina or congestive heart failure was reduced to 36.6 ⫾ 3.9 months. Conclusion: Percutaneous coronary interventions can be performed safely with a high rate of primary success in patients with severe LV dysfunction. Short-term events and complications are low, and long-term survival is acceptable. These patients have a relatively high rate of cardiac events and hospitalization after the procedure.

TCT-87 Collagen Expression and Restenosis Is Significantly Reduced After Local Delivery of 17-␤-Estradiol After Coronary Stenting. P. Geraldes, M.G. Sirois, J-F. Tanguay. Montreal Heart Institute, Quebec, Canada. Background: Extracellular matrix (ECM) of which collagen formation is a major component seems to play an important role in restenosis after balloon angioplasty (PTCA). It has been demonstrated that estrogen administration reduces type I and type III collagen synthesis by vascular smooth muscle cells in vitro. In previous studies, we have shown that local delivery of 17-␤-estradiol (17␤) prevents restenosis after PTCA by improving reendothelialization, endothelial function, and vascular healing. We hypothesized that local 17␤ may influence collagen expression after coronary stenting. Methods: Each coronary artery of a juvenile swine (n ⫽ 27) underwent PTCA and was randomly assigned to treatment (2 and 4 mg of 17␤) delivered locally or placebo and each vessel was stented. At 28 days, the animals were killed, and the tissues were fixed and red Sirius stained. Each segment was analyzed under polarized light to evaluate type I and III collagen. The area of pixels of each collagen type in the media and neointima divided by the total area of each respective region determined % collagen expression. Mean histologic injury scores and neointimal thicknesses were evaluated.

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THURSDAY 9/13/01 9:00 –10:00 Results: Results are presented in the figure.

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Ba ⫽ 2.5 ⫾ 0.3 mm; group St ⫽ 2.8 ⫾ 0.3 mm (p ⫽ NS). In-hospital MACE included 1 death (0.6%) and 2 myocardial infarctions (MI; 1.2%) in group St, and 0% in group Ba. Clinical follow-up (31.6 months ⫾ 14.1; range, 4.7 to 54.9) of the survival pts was obtained from clinic visits or telephone interview with the patient’s physician. Results: are reported in the table.

MACE Death MI Repeated PTCA CABG

Ba (%)

St (%)

p-Value

25.4 1.9 0.9 22.6 0

16.6 2.2 3.3 10 1.1

⬍0.05 NS NS ⬍0.05 NS

Conclusion: In small-vessel optimal balloon angioplasty with provisional stenting may be considered as a primary therapy with crossover to stenting only with suboptimal angiographic result.

TCT-89 Coronary Angioplasty in Unprotected Left Main Coronary Artery in the Elderly (>75 Years): Immediate and MediumTerm Clinical Outcome. I. Sheiban, A. Decio, M. Pistono, D. Alborino, C. Moretti, R. Grimaldi, G. Trevi. Division of Cardiology, University of Torino, Turin, Italy.

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Background: Coronary stenting has favorable immediate and longterm outcome in procedures performed on vessels ⬎3.0 mm in diameter. The superiority of routine stenting over balloon angioplasty in small vessels remains controversial. The purpose of this study was to analyze the long-term major adverse clinical events (MACE) after successful percutaneous coronary intervention (PCI) with provisional stenting in patients (pts) who underwent single de novo lesion treatment on native vessels with reference vessel diameter ⬍2.9 mm (definition of the subgroup of pts selected for this study). Methods: From our prospective database, between December 1996 and July 2000, 350 of the 6,489 consecutive pts who underwent PCI met the selection criteria. In 184 pts, balloon alone allowed achievement of optimal results (group Ba: sex, 129 men/55 women; diabetes, 37 [20%]; left ventricular ejection fraction [LVEF], 0.64 ⫾ 10.10) and in 166 pts stenting was required (group St: sex, 114 men/52 women; diabetes, 57 [34%]; LVEF, 0.62 ⫾ 0.11). Baseline angiographic characteristics were: left anterior descending— group Ba⫽79 pts (42%), group S ⫽ 89 pts (53 %) (p ⫽ NS); AHA/ACC classification ⫽ or ⬎ B2 lesions— group Ba ⫽ 88 pts (47%); group St ⫽108 pts [65%] (p ⫽ 0.008); pre-MLD— group Ba ⫽ 0.5 ⫾ 0.3 mm, group St ⫽ 0.5 ⫾ 0.4 mm (p ⫽ NS); and post procedure minimal lumen diameter— group

Background: Although coronary angioplasty (PTCA) is now an established treatment for patients with coronary artery disease, the results of PTCA for unprotected left main coronary artery (LMCA) disease have been disappointing owing to high mortality in both inhospital and follow-up periods. Thus, coronary artery bypass grafting (CABG) has been considered the only effective therapy for LMCA disease. However, current mortality after initial CABG for LMCA in elderly patients (⬍75 years) without previous myocardial infarction is nearly 4.5% even in highly experienced centers. The advent of “new devices” and in particular stents in interventional cardiology have improved the short-term PTCA results of unprotected LMCA disease. Methods: In this study we report our experience in unprotected LMCA angioplasty in patients (pts) ⬎75 years old (mean age, 81 ⫾ 4 years). The study population consisted of 19 consecutive patients who were considered at high risk for CABG because of concomitant systemic diseases: severe renal insufficiency (9 pts), cerebrovascular disease (6 pts), severe respiratory insufficiency (4 pts). Moreover, 6 pts had a previous myocardial infarction. LMCA disease was localized at the ostium in 6 pts, at the mid segment in 4 pts, and at the distal bifurcation in 9 pts. Calcifications were present in all pts. Concomitant significant coronary stenoses were also present on proximal or mid left anterior descending artery (LAD) in 6 pts, on proximal circumflex (LCX) in 7 pts, and on both LAD and LCX in 5 patients. Significant stenosis of right coronary artery (RCA) were present in 9 pts. Left ventricular function was normal in 7 pts, moderately depressed (ejection fraction [EF] ⬎0.40) in 4 pts, and severely depressed (EF ⬍0.35) in 8 pts. Results: Elective intra-aortic balloon pumping was required in these 8 pts. All significant stenoses were treated carrying out a complete revascularization in all pts. LMCA stenoses were predilated before stent implantation in all pts. Cutting balloon was used in all calcified ostial lesions. “Kissing” stenting was performed in all 9 pts with LMCA bifurcation lesion. Procedural success was obtained in all pts. All pts were discharged within 3 days after the procedure. A mean clinical follow-up of 6 ⫾ 2 months was obtained in all pts. There was 1 cardiac death at 4 months post procedure. Transvenous revascular-

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Conclusion: Local delivery of 17␤ reduces the neointima formation after stenting. Local delivery of 17␤ decreases type I collagen expression in the media and neointima after stenting in a porcine coronary artery model.

TCT-88 Provisional Stenting in Single De Novo Lesions in Small Vessels: Long-Term Outcome. M. Boccalatte, P. Sousa, H. Hasan, B. Farah, J.-C. Laborde, J. Fajadet, J.P. Bouhnoure, J. Marco. Unite´ de Cardiologie Interventionelle, Clinique Pasteur, Toulouse, France.

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ization was needed in 2 pts (10.5%). All other patients were event-free during follow-up period. Conclusion: Coronary angioplasty for LMCA disease in the elderly is safe with acceptable immediate and medium-term results and can be considered as valid alternative to CABG in these patients.

TCT-90 Clinical and Angiographic Determinants of Survival and Cardiac Events After Percutaneous Coronary Interventions in Patients with Severe Left Ventricular Dysfunction. B.F. Hayerizadeh1, M. Galinier2, J. Fourcade2, L. Schmutz2, F. Richez2, I. Bossi1, J. Fajadet1, J.M. Fauvel2, J. Puel2, J.P. Bonhoure2, J. Marco1. 1Unite´ de Cardiologie, Clinique Pasteur, Toulouse, France ; 2Fe´de´ration des Services de Cardiologie, Hoˆpitaux de Toulouse, Toulouse, France. Background: Percutaneous coronary interventions (PCI) are used more frequently in patients with complex coronary lesions and severe left ventricular (LV) dysfunction. However, its beneficial effect on late survival needs to be clarified. We sought to evaluate the clinical determinants of long-term survival and occurrence of major cardiovascular events in patients with severe LV dysfunction (left ventricular ejection fraction [LVEF] ⱕ0.35) undergoing PCI. Methods: The study group consisted of 363 patients with severe impairment of LV function (LVEF ⱕ0.35) who underwent first PCI in the 2 centers between May 1995 and March 2000. Acute myocardial infarction (MI; ⬍24 hours) or hemodynamically unstable patients were excluded. Mean age was 68.2 years (range, 26 to 95 years) and 15.2% were female. Mean follow-up time was 27.4 ⫾ 18.4 years (median, 24.6; maximum, 65.2) months. Independent predictors of mortality and major cardiac events (death, MI, revascularization [MACE]) were calculated using the Cox model. Results: Independent clinical predictors of overall mortality were age, hyperlipidemia and chronic obstructive pulmonary disease (COPD) (p ⬍0.05). Regarding MACE, chronic renal failure (Cr; ⬎2.0 mg/dL) was an independent predictor. Angiographic predictors in multivariate adjusted RRs on clinical variables are shown below: Death

EF ⬍0.25 Left main lesion ⱖ50% Multivessel disease‡ With ⬎1 occlusion With 1 occlusion No occlusion

RR

95% CI

2.78*

1.63–4.72

4.12* 2.56† 1.76

1.81–9.34 1.2–5.55 0.76–4.10

MACE RR

95% CI

1.92†

1.08–3.39

2.09§ 1.91§ 1.05

1.15–3.78 1.12–3.26 0.56–1.94

CI ⫽ confidence interval; RR ⫽ response rate. *p ⬍0.001. † p ⬍0.05. ‡ Reference: single-vessel disease. § p ⬍0.01.

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Cardiovascular Events After Percutaneous Coronary Interventions. B.F. Hayerizadeh1, M. Galinier2, J. Fourcade2, L. Schmutz2, F. Richez2, I. Bossi1, J. Fajadet1, J.M. Fauvel2, J. Puel2, J.P. Bonhoure2, J. Marco1. 1Unite´ de Cardiologie, Clinique Pasteur, Toulouse, France ; 2Fe´de´ration des Services de Cardiologie, Hoˆpitaux de Toulouse, Toulouse, France. Background: We sought to evaluate the importance of significant atherosclerosis and major vessel occlusion in the prognosis of patients with severe left ventricular (LV) dysfunction (left ventricular ejection fraction [LVEF] ⱕ0.35) who underwent percutaneous coronary intervention in our center. Methods: Among 363 patients with severe impairment of LV function (LVEF ⱕ0.35) who underwent first percutaneous coronary intervention (PCI) in 2 centers between May 1995 and March 2000, 86 patients (22%) had single-vessel disease. Multivessel disease was found in 283 patients (78%). Of these, 130 (36%) had 1 major vessel occlusion and 65 (18%) had more than 1 major vessel occluded. Acute myocardial infarction (MI) (⬍24 hours) or hemodynamically unstable patients were excluded. Results: There was no significant difference between the groups regarding mean age (68 years), sex (15% women), LVEF (0.297 ⫾ 0.5), and number of lesions treated (1.6 ⫾ 0.7). The subgroup of patients with major vessel occlusion had a high rate of previous MI (62% vs 38%, p ⬍0.0001), previous coronary artery bypass graft (CABG; 34.9% vs 11.3%, p ⬍0.0001), and more presentation with unstable angina (36.9% vs 24.4%, p ⫽ 0.01). Angiographic success was reported in 92.3% of patients with major vessel occlusion compared with 97.6% in patients without major vessel occlusion (p ⬍0.05). Mean follow-up time was 27.4 ⫾ 18.4 (median: 24.6, max: 65.2) months. Adjusted response rates (RRs) after adjustment for prognostic variables are presented in the table: Overall Death MVD Occlusion

N

MVD with ⬎1 occlusion MVD with 1 occlusion MVD with no occlusion

65 130 88

RR 4.12* 2.56‡ 1.76

95% CI 1.81–9.34 1.2–5.55 0.76–4.10

Major CV Events RR †

2.09 1.91† 1.05

95% CI 1.15–3.78 1.12–3.26 0.56–1.94

Reference group was single vessel disease (n ⫽ 80). CV events ⫽ cardiovascular events (DC, MI, revascularization); MVD ⫽ multivessel disease. *p ⬍0.001. † p ⬍0.01. ‡ p ⬍0.05. Conclusion: Among patients with severe LV dysfunction, patients with major vessel occlusion are more prone to long-term cardiovascular events after PCI. This suggests the need to consider a more complete revascularization strategy in this group.

TCT-92

Conclusion: Among patients with severe LV dysfunction, patients with major vessel occlusion are more prone to long-term cardiovascular events after PCI. This suggests the need to consider a more complete revascularization strategy in this group. LVEF ⱕ0.25 is a determinant of overall mortality, whereas severe left main stenosis is associated with a higher MACE in long-term follow-up.

TCT-91 Patients with Major Vessel Occlusion and Severe Left Ventricular Dysfunction Are More Prone to Late Occurrence of

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Clinical Outcomes After Coronary Angioplasty Using Long Stents in Small Coronary Vessels. G. Battista Danzi, M. Sesana, C. Capuano, A. Di Blasi, L. Baviera. Catheterization Laboratory, Poliambulanza Hospital, Brescia, Italy. Background: Several studies have implicated stent length and vessel size as contributing factors to restenosis. The aim of this study was to examine procedural, in-hospital, and long-term clinical outcomes of patients undergoing angioplasty using long stents in small coronary vessels. Methods: A total of 250 consecutive patients were treated with implantation of a single coronary stent in vessels with a mean reference

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THURSDAY 9/13/01 9:00 –10:00 diameter of ⱕ2.5 mm. The population was divided into 2 groups: short stents (ⱕ16 mm) (n ⫽ 126 patients) and a long stent group (ⱖ18 mm) (n⫽124 patients). Results: Patients treated with long stents had a more complex lesion morphology (p ⬍0.05). The mean stent length was 14 ⫾ 2 mm vs 25 ⫾ 3 mm for short versus long stent groups (p ⬍0.05). Overall procedural success was similar in the 2 groups (98% vs 98%; p ⫽ NS). The rate of major adverse cardiac events at 30 days (defined as death, acute myocardial infarction, or target vessel revascularization) was similar between short- and long-stent groups (4% vs 3%). During 1-year follow-up there was no difference in the incidence of mortality and myocardial infarction between the 2 groups (3.2% vs 4%; p ⫽ NS), while target vessel revascularization tended to occur more frequently in patients treated with long stents (19% vs 12%; p ⫽ 0.17). Conclusion: In conclusion, the use of long stents in small coronary vessels is associated with a good procedural success and low incidence of inhospital complications. However, compared with shorter stents, long stent implantation results in a trend toward a higher need for repeat revascularization during 1-year follow-up.

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Background: Stenting reduces the restenosis rate of successfully recanalized chronic coronary total occlusions (CTO) compared with balloon angioplasty alone; however, the rate still remains high. Massive plaque burden in CTO is considered to interfere with full stent expansion and be a cause of restenosis. Rotational atherectomy (RA) can be applied for plaque debulking of CTO; however, some critical complications such as perforation or no-flow should be concerned. Methods: To examine the safety and impact of pre-stent debulking on reduction in restenosis, we treated 100 patients with CTO (thrombolysis in myocardial infarction [TIMI] 0 or 1, estimated occlusive duration ⱖ1 month) by RA in 8 Japanese centers. RA was performed; maximum burr size was 1.86 ⫾ 0.22 mm. Results: RA could be performed safely in all lesions without any major complications. Adjunctive ballooning pressure was 7.7 ⫾ 2.6 atmospheres (atm), and single or multiple NIR stents were implanted with a maximum pressure of 10.5 ⫾ 3.4 atm. Maximum stent/balloon size was 3.18 ⫾ 0.26 mm and total stent lengh was 27.2 ⫾ 13.5 mm. Procedural success was obtained in 99 patients. Vessel rupture was observed in 1 patient after conventional ballooning at distal non-CTO lesion where RA burr did not pass. Non–Q-wave myocardial infarction (MI) was observed in 14 patients, but there was no Q-wave MI or coronary artery bypass graft. One patient died of infectious pericarditis after vessel rupture 1 month after the procedure. Two patients died of noncardiac cause (renal failure and lung cancer, each at 6 months). Angiographic 6-month follow-up was performed in 81 patients and target lesion revascularization (TLR) was required in 24 pts (29.6%). Predictors of TLR were the total stent length (p ⫽ 0.004) and the use of stiff conventional wire (p ⫽ 0.012). Conclusion: Pre-stent RA of CTO is safe and facilitates subsequent stent implantation. To clarify the efficacy of pre-stent debulking of CTO, a randomized study comparing stenting alone with pre-stent debulking using RA or directional atherectomy is being conducted in 20 Japanese centers.

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TCT-94 Predictors of CK-MB Release in Patients Undergoing Percutaneous Coronary Intervention with Stents and Glycoprotein IIb/IIIa Inhibitors. A. Kini, P. Lee, C. Mitre, M. Kim, M. Duffy, M. Kamran, D. Reich, S.K. Sharma. Cardiovascular Institute, Mount Sinai Medical Center, New York, New York, USA. Background: Coronary stent implantation, the main mode (up to 90%) of percutaneous coronary intervention (PCI), is associated with higher CK-MB release (compared with balloon angioplasty), largely due to side branch closure and distal micro- and macrothromboembolism. Glycoprotein IIb/IIIa inhibitor (GPI) use during stenting has been shown to decrease CK-MB release. Reliable predictors of CK-MB release in the era of stenting and GPI have not been described. Methods: We analyzed 1,026 consecutive patients without myocardial infarction (MI) undergoing stenting, with normal baseline values of CK-MB, who received GPI during PCI. Among these, 874 (85%) patients had normal CK-MB release (⬍16 U/L) and 152 (15%) had CK-MB elevation ⱖ16 U/L, with 1-3⫻ normal in 11%, 3-5⫻ normal in 2% and ⬎5⫻ normal in 2%. Significant clinical and procedural characteristics are shown in the table.

TCT-93 Debulking of Chronic Total Occlusions with Rotational Atherectomy Before Stenting (DOCTORS): A Prospective Multicenter Pilot Study. E. Tsuchikane, H. Oda, T. Matsubara, S. Sumitsuji, K. Ueda, H. Hosokawa, T. Suzuki, Y.S. Hsu, H. Tamai, O. Katoh, for the DOCTORS Investigators. Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.

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Characteristics

Normal CK-MB (n ⴝ 874)

Elevated CK-MB (n ⴝ 152)

p-Value

Age (yr) Female sex (%) LVEF Contrast volume (mL) Lesion length (mm) Thrombus (%) Side branch closure (%) Thromboembolism (%) Slow flow (%) Persistent chest pain (%)

64.8 ⫾ 11 30 0.46 ⫾ 0.20 190 ⫾ 72 12.4 ⫾ 6.1 2.2 0.2 0.6 2 1.5

68.1 ⫾ 11 40 0.44 ⫾ 0.20 209 ⫾ 95 14.4 ⫾ 13 3.3 9.2 3.3 14.4 2.9

0.001 0.01 0.03 0.005 0.003 0.001 0.001 0.01 ⬍0.0001 0.001

Results: Among the clinical characteristics, specific type of GPI, hypertension, diabetes mellitus, angina class, peripheral vascular disease, cerebrovascular accident, previous MI, and bypass surgery were not significantly different between the 2 groups. Angiographic characteristics such as vessel intervened, ACC/AHA B2/C lesion, restenotic lesion, calcification, dissection were also similar between the 2 groups. Multivariate analysis revealed age (p ⬍0.008), female sex (p ⬍0.04), LVEF (p ⫽ 0.06), slow flow (p ⬍0.0001), and side branch closure (p ⬍0.0006) to be independently correlated with CK-MB release. Conclusion: In the era of stent and GPI use during PCI, the incidence of periprocedural CK-MB elevation seems to be lower than historical controls of stenting without GPI (up to 30%). Markers of diffuse atherosclerosis (such as advanced age and long lesion) and procedural complications continue to be the predictors of CK-MB release. Based on the above observation, a prospective model has been constructed for same day discharge (14 to 15 hours post PCI) after angiographical successful stenting and 12-hour GPI infusion.

TCT-95 Use of ATW Marker Wire to Guide Choice of Stent Length. J.P. Reilly, M. Grise, M. Moussavian, P. Teirstein. Scripps Clinic, La Jolla, California, USA. Background: Stent length is a risk factor for restenosis. The usual method of choosing stent size relies on visual estimation from the angiogram. The goal of this study was to assess the value of an objective means of determining stent length using a calibrated guide wire (ATW Marker wire; Cordis) as a measurement tool.

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Methods: Consecutive lesions that were to undergo percutaneous intervention with stenting were prospectively evaluated. Angiography was performed in the least foreshortened projection. A visual estimate of stent length was made by the attending physician and recorded. The ATW Marker wire was then placed across the lesion. An estimate of stent length using the markers on the wire was then made and recorded. An appropriate length stent was then deployed. Results: A total of 22 consecutive lesions were evaluated; 9 lesions were in the left anterior descending artery, 6 in the right coronary artery, 4 in the circumflex, and 3 in saphenous vein grafts. In 5 cases (22.7%) the ATW Marker wire altered the stent length chosen. In all cases, the stent length chosen after ATW Marker wire placement was longer than that which had been originally chosen by angiography before placement of the ATW Marker wire. In 1 case (4.5%) the stent that was chosen after placement of the ATW Marker wire was removed before deployment because it was deemed to be too short and therefore changed for a longer length stent. Conclusion: The ATW Marker wire may be of aid in percutaneous intervention with stenting by providing an objective means of determining the appropriate stent length.

TCT-96 Outcome of Percutaneous Coronary Intervention in Cardiac Transplant Patients. M. Kamran, C. Mitre, A. Kini, A. Gass, S.K. Sharma. Cardiovascular Institute, The Mount Sinai Medical Center, New York, New York, USA. Background: Cardiac allograft vasculopathy (CAV) remains the main cause of late graft loss and death in heart transplant patients. Although percutaneous coronary intervention (PCI) seems to be a viable option for CAV treatment, there is limited experience/data available, primarily because of the relative small number of these patients undergoing PCI. Methods: There were 13 patients with cardiac transplant undergoing PCI at our institution from July 1996 to May 2001, with mean age 47.6 ⫾ 17 years (range, 13 to 68 years), 92% men, hypertension in 77%, diabetes mellitus in 31%, hyperlipidemia in 77%. During 19 interventions, 28 lesions were treated in the following vessels: 33.3% in left anterior descending/D1, 25% in right coronary artery, and 41.7% in left circumflex/obtuse marginal; stents were used in 53.6% of the lesions and rotational atherectomy in 33.3%. Glycoprotein IIb/IIIa inhibitors were used in 42.1% of cases. The mean lesion length was 14.7 ⫾ 4.8 mm with 21% ACC/AHA type C lesion, mean stenosis pre and post procedure was 85.5 ⫾ 8% and 11.9 ⫾ 15.4%, respectively. Results: Procedural success was achieved in all patients with no major inhospital complications and 1 procedural complication. All patients had routine angiographic follow-up at a mean duration of 6 ⫾ 3 months, 4 of them (31%) underwent target lesion revascularization. Of the 13 patients who were closely followed by the transplant team, 3 died of noncardiac cause and 1 patient died after retransplantation. Conclusion: PCI can be performed with high procedural success in patients with cardiac transplant, although they still represent a high-risk subset mainly due to poor baseline clinical profile. Follow-up angiography and/or stress test should be performed within 6 months of PCI since most of the CAV patients are asymptomatic.

TCT-97 Transradial Approach Reduces Bleeding Complications and Length of Stay in Patients Treated With Glycoprotein IIb/IIIa Inhibitors. G. Revtyak1, J. Riesmeyer2, M. Kurz3. 1Indiana Heart Physicians and St. Francis Hospital, Beech Grove, Indiana, USA; 2 Eli Lilly Company, Indianapolis, Indiana, USA; 3Centacor, Malvern, Pennsylvania, USA.

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Background: Glycoprotein (GP) IIb/IIIa inhibitors decrease ischemic complications of percutaneous coronary intervention (PCI) but have been associated with increased bleeding complications, primarily at the vascular access site. Use of the transradial (TR) approach with GP IIb/IIIa inhibitors may allow routine use of these agents while minimizing access-site complications. Also, decreased need for intensive postprocedure access-site management could result in shorter length of hospital stay (LOS) in these patients. The present study tested the hypothesis that compared with standard femoral access (FA), the transradial approach provides similar procedural outcomes with fewer access-site and bleeding complications when GP IIb/IIIa inhibitors are used. Methods: Retrospective analysis of in-hospital major adverse coronary events (MACE), major bleeding (thrombolysis in myocardial infarction [TIMI] criteria), major (requiring surgical repair), and minor (pseudoaneurysm or charted hematoma) access site complications, and postprocedural LOS was performed on 2,432 consecutive patients undergoing PCI via FA or TR approach. GP IIb/IIIa inhibitors were used in 61% of FA patients and 90% of TR patients. Demographics were similar between groups and included patients undergoing PCI for AMI, ACS, and stable angina. Results: There were no differences in in-hospital MACE between groups. Access-site complications occurred significantly less often in TR patients, and postprocedural LOS was shortened. Group FA RA

n

Maj. Bleed (n)

Maj. Compl. (n)

Minor Compl. (n)

Thrombocytop.

LOS (hr)

2,432 217

164 0*

21 0*

59 6*

17 3*

70.6 36.6*

*p ⬍0.05. Conclusion: TR approach with concomitant GP IIb/IIIa inhibitor use provides procedural outcomes similar to FA approach, but with significantly fewer access-site complications and shortened LOS. Cost savings realized through fewer complications and shorter LOS in TR patients substantially offset the costs of routine GP IIb/IIIa inhibitor use in PCI.

TCT-98 Progression of New Coronary Lesions But Not Restenosis Limits the Outcome After Coronary Artery Stenting in Diabetes Mellitus. A. Germing1, S. V. Dryander1, W. Bojara1, T. Lawo1, A. Machraoui2, B. Lemke1. 1Department of Cardiology and Angiology, BG-Kliniken Bergmannsheil, University of Bochum, Germany; 2 Department of Internal Medicine, DIAKO, Flensburg, Germany. Background: Diabetes mellitus is a major risk factor for coronary artery disease. Diabetic patients seem to have an increased rate of restenosis and a higher rate of reinterventions. The individual progression of coronary atherosclerosis should influence the treatment strategy. Indications for interventional or surgical revascularization in diabetics are a subject of controversy. Methods: A total of 307 unselected patients with coronary artery disease (60.6 ⫾ 9.8 years, 74.6% male) and percutaneous coronary intervention were included. Recurrent angina or myocardial ischemia had been required for the primary intervention. We analyzed the clinical and angiographic outcome by patient evaluation and angiography after a mean follow-up of 3 months and compared the results in patients with and without diabetes. Results: Diabetes was present in 16%. Indications for intervention were stable angina (64.8%), acute coronary syndrome (22.8%), and restenosis after previous angioplasty (12.4%). The following in-hospital postinterventional cardiac complications were documented in diabetics and nondiabetics, respectively: stent thrombosis (2.0% vs 2.7%),

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THURSDAY 9/13/01 9:00 –10:00 Q-wave-infarction (2.0% vs 1.9%), urgent reintervention (4.1% vs 3.5%). After follow-up, angiographically assessed restenosis rate in diabetics and nondiabetics was 32.7% vs 26.5% (p ⫽ NS), myocardial ischemia 32.7% vs 16.3% (p ⫽ 0.029), recurrent angina 51% vs 20.2% (p ⬍0.001). A target lesion reintervention had to be performed in 26.5% vs 17.1% (p ⫽ NS). A surgical revascularization was recommended in 6.1% vs 2.7% (p ⫽ NS). Significantly more patients with diabetes underwent an angioplasty of a new coronary lesion (16.3% vs 6.2%, p ⫽ 0.016). Conclusion: Diabetes did not reduce the primary success rate after coronary artery stenting. Although in patients with diabetes the restenosis rate was not elevated, the outcome was limited because of coronary interventions of new target lesions and recurrent angina. These findings represent the particular progression of coronary atherosclerotis in diabetes mellitus and mandate the search for an adequate treatment strategy for coronary artery disease in these patients.

TCT-99 Diabetes as a Predictor for Intravascular Ultrasound–Guided Post-Dilatation After Angiographically Successful Stent Implantation: An Observational Study from the CRUISE (Can Routine Ultrasound Influence Stent Expansion) Trial. H. Okura, P.J. Fitzgerald, M. Hayase, A. Oshima, J.A. Metz, Y. Morino, H. Kaneda, P.M. Sta¨hr, A.H.M. Hassan, P.G. Yock, Y. Honda. Stanford University, Stanford, California, USA.

P O S T E R A B S T R A C T S

Background: Several studies have indicated that final stent dimension is a strong predictor for subsequent restenosis and target lesion revascularization. Intravascular ultrasound (IVUS) guidance allows the operator to detect suboptimal stent geometry that requires additional balloon dilatation (touch-up) to improve long-term outcomes. Identification of “at risk” patients by preintervention lesion or clinical characteristics may be useful to determine a subgroup of patients in which IVUS-guided stenting is of particular benefit. The aim of this study was to investigate potential predictors of the need for touch-up following angiographically successful stent implantation. Methods: We studied 127 lesions with preintervention IVUS imaging from the IVUS-guided stent implantation arm of the CRUISE trial. Preintervention IVUS, quantitative coronary angiography (QCA), and clinical characteristics of lesions with and without IVUS-guided touch-up were compared (univariate analysis). Multivariate logistic analysis was then performed to determine the independent factors associated with touch-up. Results: Touch-up to achieve an optimal result was performed in 57 of 127 lesions (45%), based upon each operator’s discretion. Univariate predictors of touch-up included diabetes (p ⫽ 0.02), sex (p ⫽ 0.17), vessel area by IVUS (p ⫽ 0.02), lumen area by IVUS (p ⫽ 0.18), plaque area by IVUS (p ⫽ 0.02), and reference vessel diameter by QCA (p ⫽ 0.10). Multivariate logistic analysis revealed that diabetes was the only independent predictor for touch-up (p ⫽ 0.006). Conclusion: Presence of diabetes was significantly associated with the need for additional balloon dilatation after angiographically successful stent implantation. This may be a result of the diffuse plaque burden seen in diabetic patients, thereby limiting complete stent expansion or leading to initial stent size underestimation. The current finding may suggest a possible role of IVUS guidance to improve clinical outcomes in patients with diabetes.

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M.B. Leon1. 1Cardiovascular Research Foundation, Lenox Hill Heart and Vascular Institute, New York, New York, USA; 2 Washington Hospital Center, Washington, DC, USA; 3New YorkPresbyterian Hospital, Weill Cornell Medical Center, New York, New York, USA. Background: Chronic renal failure (CRF), defined as serum creatinine ⱖ2.0 mg/dL or dialysis before percutaneous coronary interventions (PCI), is associated with unfavorable clinical outcome after PCI. However, it is unclear whether there is a combined effect of CRF and dialysis on late prognosis after PCI. Methods: We evaluated the effects of CRF and dialysis on late mortality, nonfatal myocardial infarction (MI) and target lesion revascularization (TLR) in 5,078 consecutive patients without diabetes mellitus who underwent PCI. Patients were grouped as follows: group 1, 4,808 pts (10,651 lesions) without CRF; group 2, 237 pts (564 lesions) with CRF; and group 3, 33 pts (75 lesions) with CRF/dialysis. Results: Events were source documented and adjudicated by a dedicated data coordinating center. A significant additive effect of CRF and dialysis was noted with respect to short- and long-term clinical outcomes. Clinical outcomes are shown in the table.

In-hospital death (%) Q-wave MI (%) MACE (%) 1-year death (%) Q-wave MI (%) TLR (%) MACE (%)

No CRF

CRF/No Dialysis

CRF/Dialysis

p-Value

1.1 0.3 19 3.9 0.6 15.7 18.9

1.9 0 22 11.2 1.5 12.6 22.1

3.4 0 38 24.1 0 17.4 37.9

NS NS 0.02 ⬍0.001 NS NS 0.019

MACE ⫽ major adverse coronary events. Conclusion: The combination of CRF and dialysis confers a worse prognosis in nondiabetic patients undergoing PCI. At 1 year, CRF pts on dialysis have a higher mortality compared with other groups. If PCI is performed in patients with both CRF and dialysis, meticulous postprocedural scrutiny and medical management is warranted.

TCT-101 Stent with or without Balloon Predilation (SWIBAP TRIAL): Immediate and 6-Month Results of a Multicenter Prospective Randomized Trial. M. Bedossa, P. Commeau, P. Brunel, M. Gilard, C. Breut, O. Bar, P. Geslin, A. Tirouvanziam, L. Maillard, B. Moquet, P. Barragan, P. Dupouy, G. Grollier, J. Berland, P. Druelles, R. Rihani, B. Huret, C. Leclercq, H. Le Breton. CHU Rennes, Rennes, France.

Impact of Dialysis and Chronic Renal Failure in Nondiabetic Patients on 1-Year Clinical Outcome After Percutaneous Coronary Intervention. D.N. Feldman1,3, G. Dangas1, R. Mehran1, E. Aymong1, E. Grayver1, Y. Kobayashi1, L. Gruberg1, K.M. Kent2, A.D. Pichard 2, L.F. Satler2, A.J. Lansky1, G.W. Stone1,

Background: This prospective randomized trial was designed to compare direct coronary stenting with the standard procedure, which includes lesion predilation with an angioplasty balloon. The feasibility and safety of direct stenting in noncomplex coronary lesions have been reported in prospective registries. Methods: All patients ⬍76 years of age scheduled to undergo angioplasty of a noncomplex, noncalcified lesion in a ⬎3.0 mm coronary artery, who granted their informed consent, were randomized into the trial. In group 1, the stent was placed without balloon predilation, while in group 2 stent implantation was preceded by balloon predilation. The primary endpoint was the angiographic result according to procedure assigned by randomization. All the patients were observed at 6 months via phone calls. Results: Stent implantation was successful without predilation in 192 of the 197 group 1 patients (97.5%), and with predilation in 197 of the 199 group 2 patients (99%) (p ⫽ NS). No inhospital stent thrombosis or death occurred. Mean overall procedural times, mean fluoros-

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copy times, and mean volumes of contrast agent administered in group 1 versus group 2 were 23.50 ⫾ 13.54 vs 27.96 ⫾ 15.23 minutes (p ⫽ 0.002), 6.04 ⫾ 4.13 vs 6.67 ⫾ 3.65 minute (p ⫽ NS), and 135 ⫾ 65 mL vs 157 ⫾ 62 mL (p ⬍0.001), respectively. No major adverse cardiovascular events occurred at 30 days. The rates of major cardiovascular events and target vessel revascularization were comparable in the 2 groups at 6 months. Conclusion: This randomized trial confirmed the feasibility and safety of direct stenting of noncomplex coronary lesions. This technique was as successful as the conventional approach, though associated with shorter fluoroscopic exposure and procedural times and the same rate of clinical 6-month restenosis.

TCT-102 Long-Term Follow-up After Elective Treatment of Unprotected Left Main Coronary Artery Stenosis. T. Takagi, G. Stankovic, G. Tarantini, N. Corvaja, R. Albiero, G. Sivieri, C. Di Mario, A. Colombo. EMO Centro Cuore Columbus, Milan, Italy. Background: Elective stenting of de novo lesions in unprotected left main coronary arteries (ULMCA) remains an unresolved issue; no data are available regarding the long-term follow-up. Methods: We present our data from 75 consecutive patients (pts) who underwent elective treatment for de novo lesions in ULMCA. Lesions were located at the ostium (20%), body (25%), and distal part (55%) of ULMCA. The mean reference vessel size was 3.76 ⫾ 0.71 mm, the minimal lumen diameter was 1.60 ⫾ 0.71 mm, and the mean lesion length was 6.6 ⫾ 2.9 mm. Results: In all, 71 pts were treated with stents (45 pts with stent, 12 with rotablator plus stent, and 14 with directional coronary atherectomy [DCA] plus stent), and 4 pts with DCA only. Intra-aortic balloon pump was used in 55% of pts, intravascular ultrasound was performed in 47%, and glycoprotein IIb/IIIa inhibitor was used in 5%. The acute gain achieved was 2.2 ⫾ 0.8 mm. In-hospital complications: 1 patient (1.3%) died, 2 pts (2.7%) underwent coronary artery bypass graft surgery (CABG), 2 pts (2.7%) had Q-wave myocardial infarction (MI), 3 pts (4.0%) had non–Q-wave MI. Clinical follow-up was obtained for all pts after 30 ⫾ 25 months. During follow-up, 1 patient (1.5%) had MI, 6 pts (9.1%) underwent CABG, and 10 pts (15.2%) died of a cardiac event. Repeat angiography was performed in 83% of eligible pts after 5 ⫾ 2 months. Mean late loss was 1.15 mm and loss index was 0.6. Angiographic restenosis including ostium of left anterior descending artery (LAD) and circumflex artery (LCx) was present in 34.7% pts. Revascularization of ULMCA or ostium of LAD and LCx was performed in 28.9% of pts. Conclusion: Elective treatment of de novo lesions in ULMCA is feasible, with moderate risk of procedural complications. Long-term follow-up revealed a relatively high rate of angiographic restenosis and TLR including ostium of LAD and LCx, with a high incidence of cardiac death.

TCT-103 Percutaneous Coronary Intervention Versus Coronary Bypass Graft Surgery for Patients with Medically Refractory Myocardial Ischemia and Risk Factors for Adverse Outcomes with Bypass: The VA AWESOME Multicenter Registry—Comparison with the Randomized Clinical Trial. D. A. Morrison, G. Sethi, J. Sacks, W. Henderson, F. Grover, S. Sedlis, R. Esposito, K.B. Ramanathan, D. Weiman, J. Saucedo, T. Antakli, V. Paramesh, S. Pett, S. Vernon, V. Birjiniuk, F. Welt, M. Krucoff, W. Wolfe, J.C. Lucke, S. Mediratta, D. Booth, E. Murphy, H. Ward, L. Miller, S. Kiesz, C. Barbiere, D. Lewis, for the Investigators of the Department of Veterans Affairs Cooperative

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Study #385, the Angina with Extremely Serious Operative Mortality Evaluation (AWESOME). Background: The Angina with Extremely Serious Operative Mortality Evaluation (AWESOME) multicenter randomized trial and registry compared the long-term survival after percutaneous coronary intervention (PCI) and coronary artery bypass graft surgery (CABG) for the treatment of patients with medically refractory myocardial ischemia and at least 1 additional risk factor for adverse outcome with CABG. The randomized trial demonstrated comparable 3-year survival. The registry of 1,977 patients who were either physician directed to CABG or PCI, or who refused random allocation, extends the generalizability of the trial. Methods: Over a 5-year period (1995 to 2000), 2,431 patients with medically refractory myocardial ischemia and at least 1 of 5 risk factors (prior heart surgery, myocardial infarction within 7 days, left ventricular ejection fraction ⬍0.35, age ⬎70 years, intra-aortic balloon required to stabilize) were identified. By physician consensus, 1,650 patients formed a physician-directed registry assigned to CABG (n ⫽ 692), PCI (n ⫽ 651), or further medical therapy (n ⫽ 307), and 781 were angiographically eligible for random allocation; 454 of these patients constituted the randomized trial and the remaining 327 constituted a patient choice registry. CABG and PCI survival were compared using Kaplan-Meier curves and log-rank tests. Results: CABG and PCI 36-month survival rates for randomized patients were 79% and 80% and the global log rank test for survival difference over the 5 years was nonsignificant (p ⫽ 0.46). CABG and PCI 36-month survival rates were both 76% for the physician directed subgroup and the global log rank test for survival differences over the 5 years was nonsignificant (p ⫽ 0.76). CABG and PCI 36-month survival rates for the patient choice subgroup were 80% and 89% and the global log rank test for survival differences was nonsignificant (p ⫽ 0.13). The choice of revascularization differed considerably for the 2 registry subgroups; among the physician-directed subgroup, 52% were assigned to CABG (48% to PCI) compared with 31% (69% to PCI) for the patient choice subgroup. Conclusion: Both registry subgroups support the randomized trial conclusion that either PCI or CABG effectively relieves medically refractory ischemia among patients with risk factors for adverse outcomes with CABG. The registry subgroups differed markedly in the percentage revascularized by CABG.

TCT-104 Effect of Body Mass Index on In-Hospital Outcomes After Percutaneous Coronary Interventions. D.T. Ashby, M. El-Omar, Y. Iakovou, E. Aymong, M. Negoita, I. Hjazi, R. Mehran, G. Dangas, J. Moses, G.W. Stone, M.B. Leon. Cardiovascular Research Foundation, New York, New York, USA. Background: An increased body mass index (BMI) puts patients at increased risk for coronary artery disease. Vascular access in percutaneous coronary interventions (PCI) can be difficult in obese patients. The rate of vascular complications in obese patients after PCI has not been well studied. The purpose of this study was compare the rates of vascular complications after PCI according to the patient’s BMI. Methods: The study population included 6,956 consecutive patients treated with PCI for obstructive coronary artery disease between 1994 and 1999. Patients were divided into 4 groups according to their baseline BMI: underweight (BMI ⬍20; n ⫽ 229); ideal weight (BMI 20 –25; n ⫽ 1,810); overweight (BMI 25–35; n ⫽ 4,399); and obese (BMI ⬎35; n ⫽ 674). We assessed the in-hospital outcomes and vascular complications for these 4 groups. Results: The underweight and ideal weight patients were older than the overweight patients. There was a significant increase in the prevalence of cardiac risk factors as the BMI rose between the 4 groups.

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THURSDAY 9/13/01 9:00 –10:00 There was no difference in the lesion characteristics or angiographic success between the 4 groups. Major in-hospital events and vascular complications are shown in the table below. Ideal Underweight, Weight, Overweight, Obese, BMI <20 BMI 20–25 BMI 25–35 BMI >35 In-Hospital Results (n ⴝ 229) (n ⴝ 1,810) (n ⴝ 4,399) (n ⴝ 674) p-Value Angiographic success (%) Death (%) Non-Q-wave MI (%) Groin hematoma (ⱖ2 ⫻ 4 cm) (%) Pseudoaneurysm (%) Limb ischemia (%) Hematocrit drop (%) Blood transfusion (%)

99.2

97.4

97.5

98.4

NS

2.5 15.5 13.1

1.1 13.8 11.5

0.8 12.8 7.3

0.8 12.4 7.0

NS NS ⬍0.05

2.0 5.7 5.6 18.1

1.9 1.9 4.3 9.0

1.4 0.8 2.6 4.9

1.2 0.9 1.7 4.0

NS ⬍0.05 ⬍0.05 ⬍0.05

Conclusion: The underweight patients had higher rates of vascular complications after PCI, contrary to the working hypothesis that obese patients may have higher rates of vascular complications. Obesity is not a risk factor for vascular complications after PCI and may in fact be protective.

TCT-105

P O S T E R A B S T R A C T S

Predictors of Stroke in Patients Undergoing Percutaneous Coronary Interventions. R. Hajj-Ali1, R. Ezzeddine2, C. Park1, S. Katz1, B. Kaplan3, D. Marchant1, S. Green1, L. Ong1. 1North Shore University Hospital, Manhasset, New York, USA; 2University of Pittsburgh, Pittsburgh, Pennsylvania, USA; 3Long Island Jewish Medical Center, New Hyde Park, New York, USA. Background: Stroke is a rare but devastating complication of percutaneous coronary intervention (PCI) procedures. We thought to investigate the patient and procedure-related variables that predict this complication. Methods: Between January 1, 1997 and June 30, 2000, 9,171 patients underwent percutaneous coronary intervention procedures at our institution. Information was collected on the development of new strokes in the 30 days after their procedures. Results: A total of 33 patients (0.36%) had strokes. Twenty-seven (82%) events occurred during, or within the first 24 hours after the procedure. Using logistic regression analysis, we constructed a prediction model that included both clinical and procedural variables. Independent predictors of stroke included age (odds ratio [OR] 1.07 per 1 year increase in age, p ⬍0.001), history of stroke or transient ischemic attack (TIA) (OR, 3.5; p ⫽ 0.01), intervention procedure performed within 24 hours of an acute myocardial infarction (AMI) (OR, 3.5; p ⫽ 0.001), nonwhite race (OR, 3.0; p ⫽ 0.007), and the use of rotational atherectomy (OR, 2.7; p ⫽ 0.026) (table).

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Conclusion: Nonwhite race, old age, intervention in the setting of an AMI, and the use of rotational atherectomy increase the risk of stroke during or after PCI procedures.

TCT-106 Combination Wiggle Wire, “Buddy” Wire Technique for Stent Delivery in Calcified, Tortuous Coronary Arteries. Y.W. Aude, A.R. Pothula, K. Korr, M. Sharma, P.C. Gordon. The Miriam Hospital, Brown University School of Medicine, Providence, Rhode Island, USA. Background: Newer stent designs incorporating increased flexibility and lower profiles have expanded the treatment of increasingly complex coronary artery lesions. Extensive calcification and extreme vessel tortuosity, however, still limit stent delivery in a small number of patients. We describe a new technique that combines the use of 2 different guidewires to facilitate successful stent deployment. Methods: A group of 7 consecutive patients requiring percutaneous coronary intervention for critical lesions of tortuous, calcified vessels could not be stented using conventional guidewire techniques. Successful stent delivery was accomplished with the combined use of the ACS Hi-Torque Wiggle guidewire (Guidant, Temecula, CA) and either the ACS Hi-Torque Extra Sport guidewire (Guidant) or the Platinum Plus guidewire (Boston Scientific, Maple Grove, MN). Results: The mean patient age was 72 years and 5 of the 7 patients were males. The target lesions were in the mid and/or distal right coronary artery (6 patients) and the left circumflex coronary artery (1 patient). In 6 of 7 patients, stent delivery over a Sport or PT Graphix wire (Boston Scientific) followed by a Platinum Plus wire alone was unsuccessful. In 3 of 7 patients, stent delivery over a Wiggle wire alone was unsuccessful. All stents were successfully delivered when they were advanced over the Wiggle wire with a second wire placed adjacent to it, acting as a “buddy” wire to provide extra guide support and straightening of the vessel tortuosity. The successful “buddy” wires used included the Platinum Plus (6 of 7 cases) and the Sport wire (1 of 7 cases). In 1 case, the Sport wire was used unsuccessfully as the “buddy” wire, requiring exchange for a Platinum Plus wire for successful stent delivery over the wiggle wire. To date we have had no deployment failures with this combined buddy wire technique. Conclusion: In tortuous and/or calcified coronary arteries, the advancement and delivery of stents to target lesions can be accomplished with the use of the Wiggle wire, in combination with an extra support wire.

TCT-107 Epidemiology of Stent Thrombosis. R. Hajj-Ali1, R. Ezzeddine2, M. Salem3, S. Green1, D. Marchant1, S. Katz1, B. Kaplan3, L. Ong1. 1 North Shore University Hospital, Manhasset, New York, USA; 2 University of Pittsburgh, Pittsburgh, Pennsylvania, USA; 3Long Island Jewish Medical Center, New Hyde Park, New York, USA.

*Per 1 year increase in age.

Background: Stent thrombosis is a major complication of coronary stent implantation and most often results in an acute coronary syndrome soon after the procedure. Recurrent stent thrombosis is a less common complication with a poorly understood epidemiology. The purpose of this study is to evaluate the incidence of recurrent stent thrombosis and its temporal pattern of occurrence compared with primary thrombosis in a cohort of patients undergoing coronary stent implantation Methods: The study population consisted of 7,823 patients who underwent stent implantation between January 1, 1998 and March 31, 2001. All patients received heparin during the procedure and received a 2-week course of ticlopidine or clopidogrel for 1 to 2 months in addition to aspirin. Glycoprotein IIB/IIIA inhibitors were used in 16%

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OR

p-Value

95% CI

Age History of stroke or TIA PCI within 24 hr of AMI Nonwhite race Use of rotational atherectomy

1.1* 3.5 3.5 3.0 2.7

⬍0.001 0.011 0.001 0.007 0.026

1.0–1.1 1.3–9.4 1.6–7.6 1.4–6.5 1.1–6.3

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of the cases and brachytherapy in none. Primary stent thrombosis was defined as angiographically proven first-time stent thrombosis after implantation, and secondary stent thrombosis as recurrent thrombosis after mechanically or pharmacologically treating a primary thrombosis. Results: Primary stent thrombosis occurred in 1.0% (82 patients) of the study cohort and secondary thrombosis in 0.1% (8 patients). The risk of recurrence was 9.8% among those with primary thrombosis. The temporal pattern of recurrences was significantly different from that of primary events (Figure) (p ⫽ 0.003, Fisher exact test, nonrelated samples). Although ⬎50% of primary thrombosis events occurred within the first 3 days after the procedure, none of the recurrences occurred before the fourth day after stent implantation.

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Acute closure (%) Subacute thrombosis (%) 30-day CABG (%) 30-day death (%) 30-day MACE 30-day side effects* (%)

Ticlopidine

Clopidogrel

p-Value

0.5 0.5 0.4 0.8 2.2 11.6

0.2 0.5 0.4 0.9 1.5 4.6

NS NS NS NS NS ⬍0.001

CABG ⫽ coronary artery bypass graft; MACE ⫽ major adverse coronary events; MLD ⫽ minimal lumen diameter. *Noncardiac. Conclusion: Clopidogrel and ticlopidine have similar effectiveness in preventing subacute stent thrombosis even after stenting in small vessels. Side effect profile is more favorable for clopidogrel, supporting use of this agent for improved compliance after coronary stenting compared with ticlopidine.

TCT-109 Diagnosis and Management of Cardiac Tamponade Complicating Coronary Intervention. M. Fejka, J.K. Kahn, S.R. Dixon, B. Finta, P.A. Marcovitz, R.D. Safian, C.L. Grines, W.W. O’Neill. William Beaumont Hospital, Royal Oak, Michigan, USA.

Figure. Temporal pattern of occurrence of primary and secondary stent thrombosis. Conclusion: Recurrent stent thrombosis is relatively common after an initial thrombosis episode and tends to occur at a more delayed time after the intervention.

TCT-108 Effectiveness of Clopidogrel and Aspirin Versus Ticlopidine and Aspirin in Preventing Stent Thrombosis After Coronary Stenting in Small Vessels. A. Reyes, Y. Kobayashi, O. Balan, F. Arif, M. Hirose, I. Moussa, M.B. Leon, J.W. Moses, Cardiovascular Research Foundation, Lenox Hill Heart and Vascular Institute, New York, New York, USA. Background: There is little information about the effectiveness of clopidogrel plus aspirin versus ticlopidine plus aspirin in preventing stent thrombosis after stenting in small vessels. Methods: Between September 1996 and July 2000, clopidogrel and aspirin was prescribed after successful stenting of small vessels (⬍2.75 mm) in 1,032 patients with 1,291 lesions and ticlopidine and aspirin in 718 patients with 826 lesions. Results:

Ref. Diameter (mm) Lesion length (mm) Pre-MLD (mm) Post MLD (mm)

Ticlopidine

Clopidogrel

p-Value

2.28 ⫾ 0.33 10.2 ⫾ 6.0 0.74 ⫾ 0.30 2.84 ⫾ 0.43

2.34 ⫾ 0.30 12.3 ⫾ 6.4 0.68 ⫾ 0.27 2.67 ⫾ 0.38

⬍0.001 ⬍0.001 ⬍0.001 ⬍0.001

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Background: Cardiac tamponade (CT) is a potentially life-threatening complication of percutaneous coronary intervention (PCI). Methods: To determine the incidence, treatment modalities, methods of diagnosis, and outcomes of CT we analyzed a database of 25,697 PCIs performed between October 1993 and December 2000 at a highvolume center. Results: A total of 36 patients developed CT (overall incidence 0.14%). CT occurred as a result of the following interventional modalities: percutaneous transluminal coronary angioplasty (PTCA) 16 of 11,336 (0.14%), stenting 10 of 11,653 (0.09%), rotational atherectomy 4 of 1,812 (0.22%), directional atherectomy 1 of 297 (0.34%), transluminal extraction atherectomy 1 of 453 (0.22%), laser angioplasty 1 of 129 (0.8%), and percutaneous transmyocardial revascularization 1 of 17 (0.59%). Most target lesions (81%) were type B2 or C (ACC/AHA classification). The diagnosis of CT was established in the catheterization laboratory in 20 patients (mean time from PCI, 33 minutes) and out of the laboratory in 16 patients (mean time from PCI, 4 hours and 59 minutes). Echocardiography was needed in 15 patients, but 21 patients were managed based on angiographic and clinical evaluation. Overall mortality was 42% (15 of 36) and 28% of patients (10 of 36) developed myocardial infarction as a complication of the procedure. Surgery was needed in 39% of patients (14 of 36). Pericardiocentesis was the definitive therapy in 22 cases (survival 64%; 14 of 22); 2 patients required surgical pericardial drainage (survival 100%; 2 of 2), 2 patients underwent target vessel ligation (survival 100%; 2 of 2) and 10 patients had emergency CABG surgery with vessel reconstruction (survival 30%; 3 of 10). Using multiple logistic regression analysis, no significant predictors of in-hospital mortality were identified (including glycoprotein IIb/IIIa Inhibitors; n ⫽ 4). Conclusion: CT is a rare interventional complication and is associated with a high mortality. Most patients are diagnosed in the laboratory within 30 minutes from intervention, but delayed tamponade may occur within 5 to 6 hours and must be considered as a possible cause of late hypotension following PCI. Definitive treatment frequently requires cardiac surgery.

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Background: Coronary artery perforation is a rare but serious complication during percutanous coronary intervention (PCI) often resulting in further therapeutic interventions. We evaluated the incidence of such perforations during a 6-year period. Methods: Records of 14,461 PCI at a single institution from July 1995 to May 2001 were reviewed. A total of 16 (0.11%) major cardiac perforations required therapeutic interventions. Perforations that did not require any further treatments were excluded. The etiology of perforations was determined after careful review of the cineangiograms. The time of therapeutic intervention was determined to be acute if required during the initial PCI or subacute if required within 12 hours. Treatments included pericardiocentesis or pericardial window, coiling, or prolonged balloon inflation in some cases with a perfusion balloon. Results: Balloon oversizing and distal wire perforation caused the majority of coronary artery perforations. Most patients required pericardiocentesis (69%), surgery (63%) or both (50%). In all, 3 patients were treated with prolonged balloon inflations and/or coil procedures alone. Of the perforations, 11 of the 16 cases required acute treatments. This included a pacemaker wire perforation and a case related to a rotational atherectomy. Of the 11 acute cases, 8 appeared to be related to aggressive sizing of balloons (with the balloon to artery ratio of ⬎1.3:1). Only 1 acutely treated case was related to a wire perforation. All 5 subacute treatments appeared to be caused by distal wire perforations. Four patients died as a result of this complication. The hospital mortality rate for acute and subacute treatments were 27% and 20%, respectively. Treatment

Distal Wire Perforation

Oversized Balloon

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0 2

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Correlates to Cardiac Perforation Requiring Therapeutic Intervention During Coronary Intervention. P.J. Lee1, S. Katz1, L. Ong1, B. Kaplan2, D. Marchant1, S. Green1. 1North Shore University Hospital, Manhasset, New York, USA; and 2Long Island Jewish Medical Center, New Hyde Park, New York, USA.

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Conclusion: Perforations resulting in aggressive balloon sizing required acute therapeutic intervention, whereas subacute treatments appeared more frequently with distal wire perforations. Cardiac perforations remain a catastrophic complication of PCI that required treatments in bimodal temporal distribution.

TCT-111 Is Multivessel Stenting in Octogenarians Justified? Y. Kobayashi, O. Balan, F. Arif, A. Reyes, M. Hirose, M. Mohamed, Y. Iakovou, I. Moussa, M.B. Leon, J.W. Moses. Cardiovascular Research Foundation, Lenox Hill Heart and Vascular Institute, New York, New York, USA.

Age (yr)

Female (%) Diabetes mellitus (%) GP IIb/IIIa (%) Reference (mm) Pre MLD (mm) Post MLD (mm) Proc Q-MI (%) Proc CABG (%) Proc death (%) Procedure success (%) Bleeding comp (%) Vascular comp (%) Stent thrombosis (%) 30-day CABG (%) 30-day death (%) MACE at 30 days

<80

>80

p-Value

25 33 68 2.80 ⫾ 0.60 0.83 ⫾ 0.78 3.00 ⫾ 0.53 0.3 0.5 0.3 97 0.2 0.9 1.0 1.2 1.0 3.1

37 31 45 2.90 ⫾ 0.57 0.89 ⫾ 0.45 3.08 ⫾ 0.53 0 0 0 99 1.4 1.4 1.2 1.4 2.8 2.8

0.03 0.74 0.01 0.10 0.46 0.11 0.62 0.54 0.62 0.55 0.07 0.64 0.87 0.88 0.19 0.90

CABG ⫽ coronary artery bypass surgery; Comp ⫽ complication; GP ⫽ glycoprotein; MACE ⫽ major adverse cardiac event; MLD ⫽ minimal lumen diameter; Q-MI ⫽ Q-wave myocardial infarction. Conclusion: Multivessel stenting can be performed successfully with a low 30-day cardiac event rates in octogenerians. Despite advancing age, mortality rates in these patients are similar to their younger counterparts. Long-term follow-up is needed to further evaluate longevity of multivessel stenting in the aged.

TCT-112 Randomized Comparison of Ultrasound-Guided Direct Stenting and Plain Balloon Angioplasty: Early Results from a Polish Multicenter Trial. R. Gil, T. Pawłowski, D. Dudek, K. Z˙mudka, M. Lesiak, G. Horszczaruk, A. Witkowski, A. Ochała, J. Kubica, on behalf of Direct Stenting Versus Optimal angioplasty Trial (DIPOL) Investigators. Catheterization Laboratory, Szczecin, Poland. Background: Selection of the most effective percutaneous intervention for patients with coronary stenoses has not been clearly defined. Proper guidance for coronary interventions may improve their late results. Therefore we designed multicenter, randomized study comparing direct stenting with plain balloon angioplasty, both guided with intracoronary ultrasound (ICUS). Methods: As of May 2001, 108 patients (17 women, 91 men, mean age 53 ⫾ 7) were enrolled into our study. They were divided into 2 groups: group 1, direct stenting guided with ICUS (55 pts); and group 2, optimal balloon angioplasty guided with ICUS (53 pts). Primary endpoints for the procedures were: group 1, MUSIC (Multicenter Ultrasound Stenting in Coronaries Study) trial criteria; group 2 no significant dissection, minimal lumen area ⬎6.0 mm2 or ⬎65% of average of proximal and distal reference lumen area. The secondary endpoints were major adverse cardiac events (MACE) and angiographic restenosis during 6 months follow-up. Results: Procedural success was achieved in 97% of cases, however crossover to stenting was necessary in 24 (45%) patients of group 2. Periprocedural complications required ReoPro (Centocor), use in 7 (13%) patients. QCA measurements are presented in the table.

Background: Multivessel stenting is routinely performed in a single procedure even in octogenarians. Clinical outcomes of multivessel stenting in this advanced age group have not been fully evaluated. Methods: Between September 1996 and June 2000, multivessel stenting was performed in 655 patients with 1,512 lesions. Lesions were classified into 2 groups according to the age: (1) ⬍80 years old (584 patients, 1,343 lesions) and (2) ⱖ80 years old (71 patients, 169 lesions).

MLD ⫽ minimal lumen diameter; RD ⫽ reference diameter. *p ⬍0.05 between group 1 and group 2.

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MLD post RD pre

Group 1

Group 2

3.36 ⫾ 0.59* 3.25 ⫾ 0.66

2.91 ⫾ 0.49 3.31 ⫾ 0.63

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During hospitalization there were no deaths in either group, but there were 2 non–Q and 1 Q-wave myocardial infarction in group 2. As of May 2001 we have completed follow-up in 32 pts (29%). At 6-month follow-up the evidence of composite MACE was 7.1% in group 1 and 16.6% in group 2. The presence of angiographic restenosis was 8% and 12% respectively in group 1 and group 2 (p ⫽ NS). Conclusion: Our preliminary results suggest that ICUS-guided direct stenting seems to be a more effective technique for coronary intervention. It is likely that final results of this ongoing trial will elucidate the problem.

TCT-113 Clinical Outcomes After Percutaneous Coronary Intervention for Proximal Left Anterior Descending Stenoses Compared with Proximal RCA and Circumflex Stenoses: Nonstenting versus Stenting Strategies. D.T. Ashby, Y. Iakovou, M. El-Omar, E. Aymong, R. Narasimaiah, H. Faraj, R. Mehran, G. Dangas, J. Moses, M.B. Leon. Cardiovascular Research Foundation, New York, New York, USA. Background: Restenosis is a major limitation of angioplasty. Previous studies have demonstrated that treated proximal left anterior descending (LAD) stenoses have preferentially higher rates of restenosis after percutaneous coronary angioplasty than right coronary artery (RCA) and circumflex (Cx) stenoses. Stenting strategies may reduce this preferential rate of LAD restenosis. The purpose of this study was to compare the rates of adverse clinical outcomes after stent or nonstent strategies in patients with proximal LAD stenoses compared with stenoses in the proximal RCA and Cx coronary arteries. Methods: The study population included 1,270 patients with proximal coronary artery stenoses treated with nonstent or stent percutaneous coronary intervention (PCI) for single-vessel disease between 1994 and 1999. Patients were divided into 4 groups: nonstent PCI in proximal LAD (n ⫽ 168), nonstent PCI in proximal RCA/Cx (n ⫽ 217), stent to proximal LAD (n ⫽ 364), and stent to proximal RCA/Cx (n ⫽ 540). We assessed the inhospital and 1-year clinical outcomes for the groups. Results: Baseline clinical characteristics and preprocedural lesion characteristics between the groups were similar. The procedural success was higher in the stenting groups, but there were no significant differences in the major inhospital events in any of the groups. The 1-year follow-up results are shown in the table: LAD RCA/Cx LAD RCA/Cx No Stent No Stent pStent Stent p(n ⴝ 168) (n ⴝ 217) Value (n ⴝ 364) (n ⴝ 540) Value Inhospital results Procedural success (%) 1-year follow-up Death (%) Q-wave MI (%) Non-Q-wave MI (%) Target lesion revascularization (%)

91.0

86.4

0.16

97.5

97.6

0.95

3.4 0.7 4.2 21.1

5.5 1.2 3.5 12.5

0.37 1.0 0.73 0.039

6.9 0.6 3.4 10.1

6.3 0.8 3.8 13.8

0.74 1.0 0.73 0.11

MI ⫽ myocardial infarction. Conclusion: In patients with proximal stenoses treated with nonstenting strategies, there is lower procedural success than with stenting strategies and the proximal LAD stenoses have significantly higher rates of clinical restenosis than the proximal right and circumflex stenoses. A stenting strategy for proximal LAD stenoses equalizes the risk of clinical restenosis to that of proximal RCA and Cx stenoses.

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TCT-114 Sex Is Not a Risk Factor for Adverse Outcomes After Percutaneous Coronary Intervention in the Stenting Era. M. Ghani, A.R. Assali, A. Moustapha, S. Sdringola, J. Salloum, H. Awadalla, S. Saikia, S. Hale, G. Schroth, O. Rosales, R.W. Smalling, H.V. Anderson. University of Texas Medical School and Hermann Hospital, Houston, Texas, USA. Background: Women are commonly believed to have higher risks for adverse outcomes than men after percutaneous coronary interventions (PCI). The increasing uses of coronary stents and potent antiplatelet drugs have improved the outcomes of all patients undergoing PCI. Our aim was to assess whether sex influences the results of coronary stenting in the current PCI practice. Methods: We compared 380 consecutive women undergoing elective coronary stenting to 643 consecutive men. Results: After multivariate analysis with adjustment for baseline differences, sex was not significantly related to inhospital outcome (p ⫽ 0.9).

Mean age (yr) Age ⱖ75 yr Diabetes mellitus Hypertension Previous MI 2- or 3-vessel disease CABG Reference vessel diameter (mm) GP IIb/IIIa inhibitors Successful PCI Acute stent thrombosis Nonfatal MI Reintervention Inhospital death Inhospital MACE

Women (N ⴝ 380)

Men (N ⴝ 643)

p-Value

64.5 ⫾ 11.3 21% 43% 78% 11% 25% 12% 3.10 ⫾ 0.42 22% 97.2% 11 (2.9%) 10 (2.6%) 12 (3.2%) 5 (1.3%) 22 (5.8%)

60.3 ⫾ 11.1 10.6% 24% 65% 21% 23% 19% 3.20 ⫾ 0.45 26% 98.3% 6 (0.9%) 12 (1.9%) 10 (1.6%) 2 (0.3%) 23 (3.6%)

0.02 0.002 0.001 0.002 0.054 0.7 0.003 0.003 0.1 0.2 0.01 0.4 0.09 0.06 0.09

CABG ⫽ coronary artery bypass graft; GP ⫽ glycoprotein; MACE ⫽ major adverse coronary events; MI ⫽ myocardial infarction. Conclusion: Inhospital outcome of women undergoing elective coronary stenting is worse than for men because of differences in clinical and angiographic characteristics. Sex by itself is not a risk factor.

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TCT-115 Reconstruction of Saphenous Vein Graft with Self-Expanding Magic Wall Stent: Immediate and Medium-Term Outcomes. V.S. Mahadevan, V. Moohan, T.P. Matthew, I.B.A. Menown, N.P.S. Campbell, S.W. Webb, A.A.J. Adgey, M.M. Khan. Royal Victoria Hospital, Belfast, United Kingdom. Background: Management of patients with degenerated saphenous vein grafts (SVG) is difficult and repeat surgery is associated with increased mortality. Magic Wall Stent (MWS; Boston Scientific, Switzerland) because of its self-expanding nature is well suited to vein graft angioplasty. Methods: We studied the outcomes of patients who had an MWS deployed in our institution during vein graft angioplasty. Patients and procedure: MWS was implanted in 47 grafts in 40 patients over a 2-year period. Mean patient age was 66 ⫾ 7 years and graft age was 11 ⫾ 6 years. In all, 20 (50%) had a history of previous myocardial infarction. Moreover, 15 (32%) were done on grafts supplying the left anterior descending/diagonal territory, 22 (47%) in the left circumflex, and 10 (21%) in the right coronary artery territory. A total of 56 MWS stents were used. However, 35 other stents were also used to optimize

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THURSDAY 9/13/01 9:00 –10:00 lesion coverage. Distal embolisation occurred in 4 (10%) of interventions. In all, 31 patients (77%) received abxicimab. Results: Forty-four grafts (94%) had ⬍10% residual stenosis at the end of procedure. In total, 3 patients (7%) had major complications. One had perforation of the vein graft requiring a covered stent, whereas 2 had post-procedure myocardial infarction, 1 of whom died of cardiogenic shock. Mean follow-up was 24 months. Thirty-eight patients (95%) are alive at present. Twenty-one patients were restudied either for recurrence of symptoms or other vessel intervention. Twelve patients (30%) had restenosis of the saphenous vein grafts. Of these, 9 had successful repeat intervention and 2 had repeat coronary artery bypass grafting. Among the 13 patients (32%) who had only a MWS deployed, 9 had repeat angiography of which 7 (54%) did not have restenosis. Four patients have remained asymptomatic. Conclusion: MWS is a useful device with excellent procedural success with good short-term outcomes in treating lesions of SVG. However, additional stents are often required. SVG treated with MWS alone appears to be less prone to restenosis. Larger patient series need to be studied to confirm these findings.

TCT-116 Previous Stent Thrombosis and the Risk of Future Stent Thrombosis. R. Hajj-Ali1, J. Freeman1, R. Ezzeddine2, D. Marchant1, S. Green1, S. Katz1, B. Kaplan1, L. Ong1. 1North Shore University Hospital, Manhasset, New York, USA; 2University of Pittsburgh, Pittsburgh, Pennsylvania, USA.

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Background: Stent thrombosis is a major complication of coronary stent implantation that usually presents as an acute coronary syndrome resulting in a worse clinical outcome. The aim of this study is to investigate the impact of a previous episode of stent thrombosis on the risk of future stent thrombosis in patients undergoing stent implantation procedures. Methods: A total of 5,978 patients underwent stent implantation at our institution between January 1, 1998 and June 30, 2000. They were observed for at least 1 month after their procedure, and information regarding repeat hospitalization and cardiac procedures was collected. All patients were placed on aspirin as well as ticlopidine or clopidogrel. The primary endpoint of the study was angiographically documented stent thrombosis. Results: A total of 67 cases (1.1%) of primary stent thrombosis occurred during the follow-up period. In all, 8 patients had recurrent stent thrombosis. The incidence of stent thrombosis in patients with a previous episode of stent thrombosis was 12%. Using clinical and procedure-related variables, logistic regression analysis revealed previous stent thrombosis to be the strongest independent predictor of stent thrombosis (odds ratio [OR], 26.8, p ⬍0.001). Other significant predictors were, stent implantation as a treatment for acute myocardial infarction (AMI) (OR, 2.4, p ⫽ 0.001), smaller stent size (OR, 1.62 per 0.5-mm reduction in stent diameter, p ⫽ 0.003), and increasing number of implanted stents (OR, 1.4 per additional stent; p ⫽ 0.002) (table). Independent Predictors of Stent Thrombosis Predictor Variable

OR

p-Value

95% CI

Previous stent thrombosis Stent implantation during AMI Stent size Stents implanted (n)

26.8 2.4 1.6* 1.4†

⬍0.001 0.001 0.003 0.002

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Conclusion: Previous stent thrombosis is a strong independent risk factor for future stent thrombosis.

TCT-117 Impact of Stenting Compared with Balloon Angioplasty on Inhospital Outcomes of 62,849 Patients: Results from the Registry of the Brazilian Society of Interventional Cardiology (CENIC). A.G.M.R. Sousa1, M.A. Costa1, L.A. Mattos1, J. Saad2, A Labrunie2, F. Feres1, A. Abizaid1, C. Gottchall2, C. Costantini2, H. Figueira2, V. Lima2, P. Caramori2, P.S. Oliveira2, J.A. Mangione2, J.E. Sousa1. 1Institute Dante Pazzanese of Cardiology, Sa˜o Paulo, SP, Brazil; 2Brazilian Society of Interventional Cardiology, Sa˜o Paulo, SP, Brazil. Background: The BENESTENT and STRESS trials have demonstrated the benefit of coronary stents in selected coronary lesions. Whether stents provide superior immediate results compared with balloon angioplasty in unselected patients remains to be demonstrated in a large multicenter prospective investigation. Methods: From 1997 to 2000, a prospective clinical survey was made in 112 Brazilian hospitals. In these institutions, 62,849 interventional procedures were performed. Patients were grouped according to treatment: stenting (n ⫽ 37,898) and balloon angioplasty (24,951). Procedural success was defined as residual stenosis ⬍50% and TIMI 3 flow. Logistic regression analysis was used to predict hospital discharge without complications (death, myocardial infarction or urgent bypass surgery) in the total population. Results: Patients selected to stent implantation have a worse baseline clinical characteristics as compared with patients treated with balloon angioplasty. Baseline Characteristics and Inhospital Outcomes Variables

Stent

Balloon

p-Value

Mean age (yr) Male Diabetes Unstable angina Angiographic thrombus Angiographic calcium Residual stenosis ⬎15% Success Inhospital death Inhospital myocardial infarction

60.6 ⫾ 11.0 70.1% 16.9% 21.2% 19.9% 19.3% 6.0% 98.6% 1.1% 1.0%

60.0 ⫾ 10.9 66.8% 16.8% 17.8% 20.9% 16.7% 37.8% 89.3% 1.8% 1.5%

⬍0.001 ⬍0.001 NS ⬍0.001 ⬍0.001 ⬍0.001 ⬍0.001 ⬍0.001 ⬍0.001 ⬍0.001

The use of stent was retained in the multivariate model as an independent predictor of event-free- in-hospital survival (p ⬍0.0001; R ⫽ 0.05). Conclusion: Stent implantation represents half of the interventions performed in Brazil. This large, nationally representative survey has found that stent provides a better immediate outcome compared with balloon angioplasty in unselected patients. After adjustment for baseline characteristics and degree of residual stenosis, the use of coronary stents independently predicted in-hospital outcome.

TCT-118

CI ⫽ confidence interval. *Per 0.5 mm decrease in stent diameter. † Per additional stent implanted.

Cutting Balloon and Low-Pressure Stenting with Intravascular Ultrasound Guidance for Calcified Lesions: Are Calcified Lesions Contraindicated for the Cutting Balloon? T. Matsushita, M. Muto, T. Yamada, T. Tani, S. Yamakami, K. Iwata, Y. Murakami, M.

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Tsuda, M. Okamoto, J. Toyama. Aichi Prefectural Owari Hospital Cardiovascular Center, Ichinomiya, Japan. Background: We previously reported that low-pressure stenting after cutting balloon (CB) predilatation reduced stress on the vessel wall and is useful strategy for preventing restenosis. Calcified lesions are thought to be contraindicated for the CB, but apart from heavily calcified lesions, we have obtained good dilatation of calcified lesions at lower pressures than with a conventional balloon. In this study, we used intravenous ultrasound (IVUS) to assess the effect of the degree of calcification on acute results using this strategy. Methods: In 73 consecutive lesions under IVUS guidance, we used CB predilation (4 to 8 atm) and low-pressure stenting (6 to 10 atm), and analyzed acute results with quantitative coronary angiography and quantitative coronary ultrasound. Degree of calcification was graded according to the extent of lumen coverage under IVUS; grade 0 for no calcification (n ⫽ 11); grade 1 for ⬍90° calcification (n ⫽ 32); grade 2 for 90° to180° (n ⫽ 17); grade 3 for ⬎180° (n ⫽ 13). Lesions that the CB could not pass, even after predilation of a 2.25 mm conventional balloon, were excluded. Results: Lesions were classified as mild calcification (grades 0 and 1, n ⫽ 43) and moderate calcification (grades 2 and 3, n ⫽ 43) as results of these 2 groups compared. There was a tendency to higher mean inflation pressures in the moderate lesions (8.06 vs 9.15 atm), but good dilatation was obtained in both groups, with improvement in minimum lumen diameter of 0.99 ⫾ 0.36 mm to 2.97 ⫾ 0.51 mm (mild disease), and 0.97 ⫾ 0.53 mm to 3.01 ⫾ 0.56 mm (moderate calcification). IVUS evaluation after CB predilatation showed no significant differences between the groups in terms of changes in vessel area (2.24 ⫾ 1.84 vs 1.80 ⫾ 1.75 mm2), in lumen area (6.42 ⫾ 2.03 vs 5.99 ⫾ 1.88 mm2) and in plaque area (⫺4.18 ⫾ 2.28 vs ⫺4.01 ⫾ 1.89 mm2). Also, the vessel dilation rates for the 2 groups were 1.19 ⫾ 0.17 versus 1.14 ⫾ 0.15, respectively. Conclusion: Excluding heavily calcified lesions, CB predilatation plus low-pressure stenting may be as useful a strategy for calcified lesions as for noncalcified lesions.

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Methods: Data were collected from 11,709 unselected ACS pts. Baseline risk factors, use of PCI, and inhospital events were stratified according to clinical presentation and presence or absence of a cathlab. Results: Proportionally, more pts were admitted to hospitals with a cathlab in the United States than in other countries. PCI was used more frequently in pts admitted to hospitals with a cathlab. The greatest difference in the use of PCI between hospitals with or without a cathlab was found in the ST segment elevation myocardial infarction (STEMI) group, due to the more frequent use of primary PCI in pts admitted to a hospital with a cathlab (43% vs 3% in hospitals without cathlab). Inhospital mortality and (re)infarction rates in the 3 groups were the same irrespective of the presence of a cathlab. For pts with non-STEMI (NSTEMI) or unstable angina (UA), total stroke rates were similar in both types of hospitals, but more strokes were observed in STEMI pts admitted to hospitals without a cathlab. Facilities and Inhospital Events

N PCI Mortality Stroke Reinfarction

STEMI Cathlab

STEMI No Cathlab

NSTEMI Cathlab

NSTEMI No Cathlab

UA Cathlab

UA No Cathlab

2,618 1,315 (50.4%) 193 (7.5%) 32 (1.2%) 78 (3.0%)

801 38 (4.8%)* 56 (7.0%) 19 (2.4%)* 28 (3.5%)

2,291 768 (33.6%) 137 (6.1%) 21 (0.9%) 38 (1.7%)

602 25 (4.3%)* 41 (6.9%) 6 (1.0%) 9 (1.5%)

3,141 731 (24.1%) 110 (3.6%) 13 (0.4%) 6 (0.2%)

1,256 38 (3.2%)* 46 (3.7%) 7 (0.6%) 2 (0.2%)

*p ⬍0.05. Conclusion: The availability of a cathlab is associated with more frequent use of PCI in pts presenting with ACS, especially in those with STEMI. Despite this, no differences are apparent with respect to in-hospital mortality.

TCT-120

Interventional Procedures and Inhospital Outcomes in Patients with Acute Coronary Syndromes: Observations from the Global Registry of Acute Coronary Events (GRACE). I. Sadiq1,2, F. Van de Werf4, A. Avezum5, D. Gulba6, S. Goodman7, A. Budaj8, D. Brieger9, J. Gore3, C. Cannon10, K. White2, B. Kennelly11. 1 Cardiology Division, 2Center for Outcomes Research, and 3Division of Cardiovascular Medicine, University of Massachusetts Medical School, Worcester, Massachusetts, USA; 4Cardiology U.Z. Gasthuisberg, Leuven, Belgium; 5Coronary Care Unit, CTI-A Hospital Albert Einstein, Sa˜o Paulo, Brazil; 6Cardiology, Krankenhaus Duren Medizinische Klinik, Duren, Germany; 7 Canadian Heart Research Center, University of Toronto, Toronto, Ontario, Canada; 8Department of Cardiology, Grochowski Hospital, Warsaw, Poland; 9Coronary Care Unit, Concord Hospital, Concord, Australia; 10Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts, USA; 11Cardiology Department, Hoag Memorial Presbyterian Hospital, Newport Beach, California, USA. Background: The extent to which the availability of a catheterization laboratory (cathlab) influences the use of percutaneous coronary intervention (PCI) in patients (pts) with acute coronary syndromes (ACS), and the subsequent impact on clinical outcomes, is not known. We sought to investigate the relation between type of facilities, use of PCI and inhospital outcomes using information collected from the multinational Global Registry of Acute Coronary Events (GRACE) registry.

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Inhospital and Long-Term Outcomes of Stenting for Long Lesions in Small Coronary Artery. J. Andre´a, J. Boechat, C. Falca˜o, L. Carestiato, D. Cortez, R. Miguel, R. Latorre, R. Corvisier, and H. Figueira. Clı´nica Sa˜o Vicente, Sa˜o Vicente, RJ, Brazil; Hospital CardioTrauma, Ipanema, RJ, Brazil. Background: Long lesions as significant stenosis ⬎20 mm in small coronary arteries (SCA), arterial reference diameters ⬍3 mm, is considered unfavorable for percutaneous coronary interventions (PCI); however, the results of coronary stenting are controversial. The purpose of this study was to assess the early and long-term results of stenting for long lesions in SCA. Methods: Between January 1998 and February 2001, 46 pts were underwent coronary percutaneous interventions with 62 stent implantations. The baseline characteristics: 31 men (67.3%), mean age 65.7 ⫾ 12 years, diabetes 28.3%, hypertension 52.2%, dyslipidemia 32.6%, prior acute myocardial infarction (AMI) 28.3%, prior percutaneous transluminal coronary angioplasty (PTCA) 13%, and prior coronary artery bypass grafting (CABG) 10.9%. Multivessel disease (2- and 3-vessel) was found in 31 (67.4%) pts; left ventricular function was normal or mildly reduced in 71.7%, but there was moderate or severe dysfunction in 28.3%. Clinical condition was stable angina in 28.3% and acute coronary syndrome (unstable angina and acute myocardial infarction) in 71.7%. Vessels treated were as follows: left anterior descending, 48.4%; left circumflex, 17.2%, right coronary artery, 34.4%. Glycoprotein IIb/IIIa inhibitors were given to 4 pts (8.6%).

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THURSDAY 9/13/01 9:00 –10:00 Results: Procedural success rate was 95.9%. Inhospital mortality was 0; myocardial infarction and stent embolism occurred in 1 pt. Urgent CABG, vascular complications, and subacute thrombosis were not shown. Clinical follow-up was at mean 23.5 (range, 2 to 38) months in 32 pts (69.6%). We determined the 95% confidence interval to evaluate the results. Event-free angina occurred in 21 (mean, 65.6 ⫾ 16.6%); PTCA in 2 (6.3 ⫾ 8.4%), elective CABG in 3 (9.4 ⫾ 10.1%), target lesion revascularization in 3 (9.4 ⫾ 10.1%), and death in 2 pts (6.3 ⫾ 8.4%). Conclusion: Stenting for long lesions in SCA can be performed safely, with good acute results and an acceptable rate of clinical restenosis and new revascularization procedures.

TCT-121 Quantitative Coronary Angiography Versus Intravascular Ultrasound in the Evaluation of High-Pressure: Optimal Stent Deployment. S. Salama, M. Abdelghani, W. El-Naggar, K. Sorour, and S. El-Tobgy. Cardiology Department, Cairo University, Egypt.

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Background: Although intravascular ultrasound (IVUS) allows more accurate assessment of proper stent expansion, it is not readily available for routine application. There is a need to define the relative value of quantitative coronary angiography (QCA) in the evaluation of optimal stent deployment (OSD). Our objective was to compare QCA with IVUS imaging in the evaluation of optimal stent expansion using high-pressure (HP) inflation. Methods: The study included 45 men, mean age 53 ⫾ 7 years, who had QCA and IVUS evaluation after stent deployment at low pressure (LP) (11.8 ⫾ 0.5 atm) followed by HP (18.6 ⫾ 1.1 atm, p ⬍0.001). QCA was performed at 5-inch magnification in the same angiographic projection (right anterior oblique 25°, caudal 20°) using Philips (Netherlands) computerized edge detection system. Stent expansion index (Exp Ind) was calculated as stent minimal lumen diameter (MLD)/ average reference lumen diameter (RLD) %. Angiographic evidence for OSD included the appearance of step-up or step-down and instent residual diameter stenosis ⬍20%. IVUS examination was performed using a 3.2Fr monorail system and a 30-MHz transducer-tipped catheter (Boston Scientific, Boston, MA). IVUS criteria for OSD were stent Exp Ind (stent minimal lumen area (MLA)/average reference lumen area) ⱖ90% in addition to complete apposition of the stent struts against the vessel wall over its entire length. Results: Results are shown in the table. The mean RLD was 3.0 ⫾ 0.5mm by QCA and 3.4 ⫾ 0.5 mm by IVUS, p ⬍0.001. QCA Stent parameters MLD (mm) MLA (mm2) Exp Ind (%) Optimal deployment (%)

LP

HP

2.8 ⫾ 0.5* 3.2 ⫾ 0.4* 6.6 ⫾ 2.1* 8.4 ⫾ 2.6* 92 ⫾ 28 122 ⫾ 38 77* 100†

IVUS p-Value

LP

HP

⬍0.0001 3.2 ⫾ 0.4 3.5 ⫾ 0.4 ⬍0.0001 8.3 ⫾ 2.0 12.5 ⫾ 2.8 ⬍0.0001 96 ⫾ 32 117 ⫾ 24 ⬍0.02 10 87

p-Value ⬍0.0001 ⬍0.0001 ⬍0.001 ⬍0.001

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TCT-122 Trends in the Incidence of Side Branch Occlusion as the Etiology of Abrupt Vessel Closure in the Stent Era. F.Q. Almeda, S. Nathan, J.E. Calvin, J.E. Parrillo, L.W. Klein. Rush-Presbyterian–St. Luke’s Medical Center, Chicago, Illinois, USA. Background: Side branch occlusion (SBO) complicates a small but significant number of percutaneous coronary interventions (PCI). The incidence of SBO as the etiology of abrupt vessel closure (AVC) in the intracoronary stent era has not been well studied. Methods: All complications occurring during 3,300 consecutive PCIs performed from April 1994 to December 2000 at a single referral institution were analyzed using a prospectively collected database. AVC was defined angiographically as documented TIMI 0 flow. Results: We examined the rate of change in the use of intracoronary stents per year using linear regression with analysis of variance (ANOVA) and found an average increase of 9.4% per year (p ⬍0.05) from 0.4% in 1994 to 57% in 2000. We used linear regression with ANOVA to estimate rate of change per year and found a steadily decreasing incidence of AVC of ⫺0.76% per year (p ⬍0.05) from 5.9% in 1994 to 1.1% in 2000. Analysis using the Pearson correlation showed that the decreasing incidence of AVC was inversely correlated with the increasing percentage of intracoronary stents placed over this time period (r ⫽ ⫺0.97, p ⬍0.001). Similarly, the percentage of side branch occlusion as the etiology of abrupt vessel closure has shown an increasing trend over time, and this positively correlated with the increased use of intracoronary stents (r ⫽ 0.85, p ⫽ 0.015) using Pearson correlation (figure).

Figure. Trends in the percent of side branch occlusion as the etiology of abrupt vessel closure versus percent intracoronary stent usage over time. Conclusion: The percentage of SBO as the etiology of AVC has increased over time and is positively correlated with the increased use of intracoronary stents.

TCT-123

*p ⬍0.0001, †p ⬍0.01 for statistical difference between QCA parameters and corresponding IVUS measurements.

The Use of Quantitative Coronary Angiography (QCA) and Intravenous Ultrasound Measurements Correlations to Perform Optimal QCA-Guided Stenting. S. Salama1, M. Abdel Ghani1, W. El Naggar1, K. Sorour1, M. Osman2, S. El Tobgy1. 1Cardiology Department, Faculty of Medicine, and 2 Department of Statistics, Faculty of Economics, Cairo University, Cairo, Egypt.

Conclusion: Both QCA and IVUS reflected the significant enlargement in stent dimensions after HP inflation. However, QCA underestimated all IVUS measurements, although the stent expansion index was not significantly different. When compared with IVUS parameters, assessment by QCA was associated with a high incidence of false positive OSD, which was substantially reduced at HP stent expansion.

Background: Quantitative coronary angiography (QCA)-guided stenting is hampered by the lack of accurate measurement of reference lumen diameter (RLD), reference vessel diameter (RVD), and stent minimal lumen area (SMLA). These parameters are more precisely obtained from intravenous ultrasound (IVUS) examination. Our objective was to determine whether models relating QCA (Q) and IVUS (I)

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measurements can be used to predict the actual IVUS parameters. These models can then be used to perform optimal stent deployment guided only by QCA data. Results: We recorded simultaneous QCA and IVUS measurements in 78 consecutive patients (pts) who had 90 stents deployed at high pressure. Data in total cases (mean ⫾ SD): I-RLD 3.4 ⫾ 0.39 mm, Q-RLD 3.1 ⫾ 0.44 mm, I-RVD 4.3 ⫾ 0.41 mm, stent size 3.4 ⫾ 0.31 mm, inflation pressure 18.3 ⫾ 1.6 atm. Patients were randomly divided into a training group (group 1, 45 stents) and a test group (group 2, 45 stents). The following models were derived in group 1 and tested in group 2: (1) In group 1, Q-RLD correlated with I-RLD, r ⫽ 0.75, p ⬍0.0005. The regression equation, calculated (C) as (C)RLD ⫽ 1.52 ⫹ 0.6 (Q-RLD), was applied to derive CRLD in group 2 pts. (2) In group 1, an index relating RLD to RVD was derived as CRLD/I-RVD: mean ⫽ 0.79 (95% confidence interval, 0.77– 0.81). This value was used to obtain a CRVD in group 2 by dividing CRLD by 0.79 in each case. From models 1 and 2, a proper stent size at a given inflation pressure can be selected to fit between the calculated RLD and RVD. (3) In group 1, I-SMLA correlated with Q-SMLA, r ⫽ 0.49, p ⫽ 0.002. The regression equation C-SMLA ⫽ 5.16 ⫹ 0.49 (Q-SMLA) was used to derive a calculated SMLA in group 2 pts. Model 3 can be used to assess the SMLA after stent deployment. Paired t test showed no significant difference between calculated and IVUS measurements obtained in the test group (t ⫽1.45, p ⫽ 0.15 for RLD, t ⫽ 1.03, p ⫽ 0.31 for RVD, t ⫽ 0.26, p ⫽ 0.79 for SMLA). The individual differences ranged from ⫺0.5 to ⫹0.5 mm for RLD in 98% of cases and for RVD in 89% of cases. The differences ranged from ⫺1.0 to ⫹1.0 mm2 for SMLA in 77% of cases. Conclusion: Mathematical models correlating QCA and IVUS measurements can be used to predict IVUS-derived vessel and stent parameters, and hence improve the accuracy of QCA-guided stenting.

TCT-124 Influence of Stent Diameter in the Results of Direct Stenting Technique without Predilatation. I. Lozano, R. Lopez-Palop, E. Pinar, E. Cortes, P. Carrillo, M. Contreras, F. Pico, M. Valdes. Department of Cardiology, Hospital Virgen Arrixaca, Murcia, Spain. Background: The advantages of the direct stenting (DS) technique have been proved in previous reports. It also has been demonstrated that elective stenting in small vessels has particular features in comparison with bigger vessels. In this study we analyze the influence of stent diameter in DS. Methods: We retrospectively evaluated 987 consecutive lesions in 773 patients where DS was attempted. Patients were divided into 2 groups: a group with 2.5-mm stent (SS) and a second group with ⱖ2.75-mm stent (BS). We analyzed the percentage of success in DS, the need for postdilatation with another balloon to improve results, and the percentage of cases with vessel dissection after the first stent. Results: There were a total of 237 and 750 lesions in the SS and BS groups, respectively. Differences were found in mean age (SS ⫽ 64.4 ⫾ 10.4 years, BS ⫽ 62.3 ⫾ 11 years; p ⫽ 0.009), female sex (SS ⫽ 33.2%, BS ⫽ 17% ; p ⬍0.0001), diabetes (SS ⫽ 44% BS ⫽ 33.1% ; p ⫽ 0.003), proximal vessel tortuosity (SS ⫽ 5.4%, BS ⫽ 2.5% ; p ⫽ 0.034), reference vessel diameter (SS ⫽ 2.59 ⫾ 0.57, BS ⫽ 3.24 ⫾ 0.66 ; p ⬍0.001), pressure of deployment (SS ⫽ 15.44 ⫾ 2.34,

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BS ⫽ 15.83 ⫾ 2.28 ; p ⫽ 0.023), percentage of success with DS (SS ⫽ 85.5%, BS ⫽ 95.5% ; p ⬍0.0001), and need of postdilatation (SS ⫽ 1.9%, BS ⫽ 4.8%; p ⫽ 0.039). There were no differences in percentage of stenosis (SS ⫽ 77.05 ⫾ 10.87, BS ⫽ 77.06 ⫾ 11.95; p ⫽ 0.99), calcification (SS ⫽ 5.4% BS ⫽ 4.9%; p ⫽ 0.73), lesion angulation (SS ⫽ 2.5%, BS ⫽ 2.2%; p ⫽ 0.8), stent length (SS ⫽ 13.59 ⫾ 4.59, BS ⫽ 13.91 ⫾ 4.4; p ⫽ 0.321), or dissection after DS (SS ⫽ 4.7%, BS ⫽ 4.4%; p ⫽ 0.85). In multivariate analysis only stent diameter, vessel tortuosity, and lesion angulation were independent variables associated with failure of DS. Conclusion: The 2.5-mm stent is associated with a lower success rate with the DS technique. Proximal vessel tortuosity and lesion angulation are also associated with a higher rate of failure.

TCT-125 Long-Term Outcome After ACS Multi-Link DUET Stent Implantation. M. Gyongyosi, P. Siotrzonek, I. Lang, H. Sochor, D. Glogar, on behalf of The Austrian MULTI-LINK Duet Stent Registry (AMULET). Division of Cardiology, University of Vienna Medical Center, Vienna, Austria. Background: The different designs of stents influences long-term outcome of patients with intracoronary stent implantation. The aim of the present study was to analyze the clinical and angiographic results 6-month after ACS Multi-Link DUET (Guidant Corp., Santa Clara, CA) stent implantation. Methods: Between January 1998 and April 1999, 340 patients were enrolled at 11 study centers. Patients were treated with MULTI-LINK DUET coronary stents in a total of 364 vessels (1.1 stent per lesion). The primary study endpoint was major adverse cardiac events (MACE) 30 days after stent implantation and at 6-month follow-up (FUP). Results: Stent deployment was successful in 99% of lesions; delivery failure occurred in 1% of lesions. After stent implantation, the minimal lumen diameter increased from 0.95 ⫾ 0.49 to 2.72 ⫾ 0.41 mm, the reference diameter from 2.84 ⫾ 0.42 to 3.04 ⫾ 0.37 mm, and the percent diameter stenosis decreased from 66.7 ⫾ 15.9 versus 10.6 ⫾ 7.5%. Two (0.6%) acute stent thromboses occurred, requiring repeated angiography and revascularization. During the 1-month clinical FUP, further revascularization was performed in an additional 3 patients (0.9%) due to subacute stent thrombosis. During the 6-month FUP, 1 patient died and acute myocardial infarction occurred in 5 patients (1.5%). Reintervention due to stent restenosis was necessary in 19 patients. Thus, the composite MACE was 10% (30 patients). Univariate logistic regression analysis revealed a significant (p ⬍0.05) association between the incidence of MACE and small pre-stent reference diameter and longer stenoses. Multivariate analysis resulted in a small pre-stent reference diameter as a significant independent predictor for the occurrence of MACE after implantation of MULTI-LINK DUET stent. Receiver operator characteristic analysis resulted in a 2.72-mm pre-stent reference diameter as cut-off point for the occurrence or absence of MACE (sensitivity/specificity, 67%; predictive accuracy, 0.68). Conclusion: The use of the MULTI-LINK DUET stent for coronary implantation resulted in a high procedural success rate and low restenosis and reintervention rates even 6 months after implantation.

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