- Email: [email protected]
Drug-eluting stents: Failures and restenosis
THURSDAY 9/30/04 10:30
AM–12:30 PM
(Hall D and E on Level 2)
Drug-Eluting Stents: Failures and Restenosis Thursday, September 30, 2004 10:30 AM-12:30 PM Hall D and E on Level 2 (Abstract nos. 456-467)
TCT-457
TCT-456 Clinical, Procedural, and Angiographic Predictors of Restenosis following Sirolimus-Stent Implantation at 8-Month Follow-Up. D. Orlic, Clinical center of Serbia, Belgrade, Serbia; E. Bonizzoni, EMO Centro Cuore Columbus, Milan, Italy; G. Stankovic, Clinical Center of Serbia, Belgrade, Serbia; A. Chieffo, San Rafaelle Hospital, Milan, Italy; F. Airoldi, San Rafaelle Hospital, Milan, Italy; I. Iakovou, EMO Centro Cuore Columbus, Milan, Italy; M. Ferraro, EMO Centro Cuore Columbus, Milan, Italy; G. Vitrella, San Rafaelle Hospital, Milan, Italy; I. Michev, San Rafaelle Hospital, Milan, Italy; G. Sangiorgi, EMO Centro Cuore Columbus, Milan, Italy; N. Corvaja, EMO Centro Cuore Columbus, Milan, Italy; A. Colombo, EMO Centro Cuore Columbus, Milan, Italy. Background: Less reduction in neointimal proliferation was reported in some subsets of patients (diabetics) with lesions (small vessels, long lesions, bifurcation lesions), indicating potential predictors of restenosis in sirolimus-eluting stents (SES; CYPHER, Cordis, a Johnson & Johnson company, Warren, NJ). This study was performed to determine independent predictors of angiographic and clinical restenosis after SES implantation in unselected lesions. Methods: From April 16, 2002, to August 1, 2003, 629 consecutive patients with 1279 lesions were treated with 1434 SES. We excluded from the study patients who had at least 1 of the following criteria: 1) major adverse cardiac event (death, myocardial infarction [MI] due to subacute SES thrombosis, repeat percutaneous coronary intervention [PCI], or coronary artery bypass graft [CABG]) within 30 days after the index procedure; 2) death or MI caused by late SES thrombosis between 1 and 8 months; 3) 2-step PCI; 4) paclitaxel or bare-metal stent implantation; 5) angiographic failure (final diameter stenosis ⱖ30% or TIMI flow ⬍3); or 6) clinically driven follow-up angiography between 1 and 6 months after the index procedure showing absence of restenosis. Eight-month clinical follow-up was completed in 536 patients (98.9% of eligible patients) at a mean time of 9.3 ⫾ 2.8 months. Angiographic follow-up was undertaken, as clinically driven or as routine suggested, at 8 months in 255 patients at a mean time of 8.0 ⫾ 2.8 months. Thus, 536 patients with 1107 lesions (1244 SES implanted) constituted the study group. Clinical, angiographic, and procedural variables were analyzed to determine independent predictors of angiographic (diameter stenosis ⱖ50%) and clinical (target lesion revascularization; TLR) restenosis at 8-month follow-up. Results: Angiographic restenosis was found in 71 patients (102 restenotic lesions) and clinical restenosis in 52 (9.6%) patients with 72 lesions (6.5%). Multivariate analysis revealed independent predictors of angiographic restenosis: stented segment length (odds ratio [OR] 1.04, 95% confidence interval [CI] 1.02–1.06, p ⫽ 0.0004), stented side branch of bifurcation lesion (OR 2.44, 95% CI 1.21– 4.93, p ⫽ 0.01), prior CABG (OR 2.03, 95% CI 1.12–3.66, p ⫽ 0.02), and in-stent
The American Journal of Cardiology姞
restenosis (ISR; OR 1.86, 95% CI 1.03–3.36, p ⫽ 0.04). Multivariate analysis identified predictors of TLR: ISR (OR 2.93, 95% CI 1.57– 5.45, p ⫽ 0.0007), prior CABG (OR 2.60, 95% CI 1.36 – 4.94, p ⫽ 0.004), stented side branch of bifurcation lesion (OR 2.10, 95% CI 1.13–3.89, p ⫽ 0.02), and stented segment length (OR 1.02, 95% CI 1.0004 –1.04, p ⫽ 0.045). Conclusions: In this study, stented segment length, in-stent restenosis, stented side branch of the bifurcation lesion, and prior CABG were identified as independent predictors of restenosis following SES implantation.
Drug-Eluting Stents and Patterns of In-Stent Restenosis. R. Mehran, S. Kesanakurthy, G.D. Dangas, S. Iyer, C. Spatareanu, N. Elliott, F. Bajraktari, J. Lander, A. Nikitina, I. Moussa, E. Kreps, M. Collins, J.W. Moses, G.W. Stone, M.B. Leon. The Cardiovascular Research Foundation and the Lenox Hill Heart and Vascular Institute, New York, NY. Background: The patterns and incidence of in-stent restenosis (ISR) after implantation of bare-metal stents have been well established. Drug-eluting stents (DES) profoundly suppress in-stent neointimal hyperplasia, the main pathological substrate for in-stent restenosis (ISR), and dramatically reduce clinical and angiographic restenosis. However, the patterns of ISR associated with the use of DES have not been studied systematically. Methods: Between April 2003 and February 2004, a total of 2,338 consecutive patients (mean age 61years, 62% male, 34% diabetics) having a total of 4,231 lesions underwent implantation of sirolimuseluting stents (CYPHERTM). Information on clinical outcomes was obtained by telephone interviews at 30 days and 6 months. Results: ISR occurred in 44 lesions in 39 patients. Of the 44 ISR lesions, 1 presented with diffuse ISR type II, 2 with diffuse ISR type III, 39 with focal type I, and 2 with total occlusion type IV. ISR lesions were treated by repeat stenting using CYPHER (37/44, 84%), repeat balloon alone (6/44, 13.6%), and 1 patient received a Heparin-coated stent (2.2%). In contrast to the previous 6 months (October 2002 to April 2003), 282 patients with 311 lesions were treated for ISR after bare-metal stents. This represents an 86% reduction in ISR cases at Lenox Hill Hospital for this 6-month period since DES approval. Conclusions: The use of CYPHER is associated with a major reduction in cases of ISR and a change in the pattern of ISR from diffuse (with bare-metal stents) to a focal, easier treatable pattern. These data support the important impact of DES in effectively treating CAD and changing the paradigm of PCI cases in catheterization laboratories, where DES are used in majority of cases.
TCT-458 Paclitaxel-Eluting Stents Reduce Need for Subsequent Coronary Artery Bypass Graft Surgery by Changing the Incidence and Pattern of Restenosis. R. Caputo, SJH Cardiology Associates; D.A. Cox, Mid Carolina Heart Institute; J.J. Popma, Brigham and Women’s Hospital; J. Hermiller, St. Vincent’s Hospital; C. O’Shaughnessy, Elyria Memorial Hospital; J.T. Mann, Wake Forest Medical; M. Turco, Washington Adventist Hospital; S.G. Ellis, Cleveland Clinic Foundation; G.W. Stone, Cardiovascular Research Foundation. Background: Target vessel failure following implantation of baremetal coronary stents (BMS) results in the need for coronary artery bypass graft surgery (CABG) at 1 year in 4% to 10% of patients. Whether drug-eluting stents reduce this adverse event is unknown.
SEPTEMBER 30, 2004
TCT ABSTRACTS/Poster
211E
P O S T E R A B S T R A C T S
THURSDAY 9/30/04 10:30 Methods: One year outcomes for 1,314 patients randomized to BMS vs paclitaxel-eluting stents (PES) in the TAXUS IV trial were examined. Results: In the overall group, target vessel revascularization/CABG at 1-year was required in 37 patients (2.8%), including 4.0% after BMS and 1.8% after PES (p ⬍0.0001). Multivariate predictors of CABG for the entire population at 1 year appear in the Table. Among patients randomized to PES, the only multivariate predictor for CABG was inability to deliver a study stent (p ⫽ 0.04). One-year major cardiac adverse events was lower with PES compared with BMS (10.8% vs 20.0%; p ⬍0.001) with no difference in the incidence of cardiac death or MI between groups. Compared with BMS, PES reduced the incidence of TVF from 19.4% to 10.0% (p ⬍0.001) and in-stent angiographic restenosis from 24.4% to 5.5% (p ⬍0.001). Moreover, the diffuse pattern of restenosis was reduced from 53.5% with the BMS to 13% with PES (p ⫽ 0.006). Among patients with restenosis, the mean lesion length was 9.49 ⫾ 4.5 mm after PES vs 14.79 ⫾ 8.21 mm after BMS (p ⫽ 0.0002). Moreover, a diffuse pattern of restenosis was observed in 63.3% in patients requiring CABG vs 6.2% in those not requiring CABG (p ⬍0.0001).
Multivariate Predictors for CABG
Hazard Ratio (95% CI)
p Value
BMS randomization LAD lesion location No study stents implanted Total stent length Reference vessel diameter
0.45 (0.22–0.92) 2.30 (1.16–4.58) 0.26 (0.07–0.99) 1.03 (1.00–1.07) 0.28 (0.13–0.60)
0.028 0.018 0.049 0.047 0.001
AM–12:30 PM
(Hall D and E on Level 2)
late loss of approximately 0.6 mm or in-stent late loss of 0.75 mm can be accommodated within stents of the size used before TLR exceeds 5%. Curves for smaller and larger vessels are shifted left and right, respectively, and will be presented. Simulation modeling suggests that a 50% increase in the variance of late loss for TAXUS patients would have increased TLR from about 3.8% to 7.4%, and an increase in rightward skewedness from 0.00 to 0.40 would have increased TLR from 3.8% to 5.7%.
CI ⫽ confidence ratio; LAD ⫽ left anterior descending coronary artery.
P O S T E R A B S T R A C T S
Conclusion: By reducing both the occurrence and severity of restenosis, the paclitaxel-eluting stent significantly enhances freedom from CABG at 1-year compared with a bare-metal stent.
TCT-459 What Is the Threshold for “Acceptable” Late Loss in the DrugEluting-Stent Era? Insights from the TAXUS IV Angiographic Substudy. S.G. Ellis, The Cleveland Clinic Foundation, Cleveland, OH; J.J. Popma, Brigham & Women’s Hospital, Boston MA; J.M. Lasala, Washington University, School of Medicine, St. Louis, MO.; J.J. Koglin, Cardiovascular Clinical Affairs, Boston Scientific, Natick, MA; D.A. Cox, Mid Carolina Cardiology, Charlotte, NC; J. Hermiller, St. Vincent’s Hospital, Indianapolis, IN; C. O’Shaughnessy, Elyria Memorial Hospital, Elyria, OH; J.T. Mann, WakeMed, Raleigh, NC; M. Turco, Washington Adventist Hospital, Tacoma Park, MD; R. Caputo, St. Joseph’s Hospital, Syracuse, NY; P. Bergin, Sacred Heart Medical Center, Eugene, OR; J. Greenberg, Florida Hospital, Orlando, FL; G.W. Stone, Cardiovascular Research Foundation, New York, NY. Background: Late lumen loss following coronary stenting has been used as a measure of stent performance and antirestenosis drug effectiveness. However, the relationship between late loss and its statistical distribution (heterogeneity of effect) to target lesion revascularization (TLR) in patient populations in the drug-eluting stent (DES) era is incompletely understood. Methods: We analyzed this relationship in 582 patients (de novo, native vessel lesions, reference diameter ⫽ 2.8 ⫾ 5mm, lesion length ⫽ 12 ⫾ 5 mm). Results: TLR was closely but nonlinearly related to both in-stent and analysis-segment late loss (c statistics ⫽ .92 and .93; see Figure). The inflection point on these curves suggests that an analysis segment
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Conclusions: Thus, both absolute late loss and the heterogeneity of response determine TLR in the DES era.
TCT-460 Mechanism and Angiographic Patterns of Restenosis after Paclitaxel-Eluting Stent Implantation. I. Iakovou, EMO, Centro Cuore Columbus; T. Schmidt, Department of Cardiology, Klinikum Siegburg Rhein-Sieg GmbH, Seigburg, Germany; F. Airoldi, San Raffaele Hospital; A. Chieffo, San Raffaele Hospital; E. Grube, Department of Cardiology, Klinikum Siegburg Rhein-Sieg GmbH, Seigburg, Germany; U. Gerckens, Department of Cardiology, Klinikum Siegburg Rhein-Sieg GmbH, Seigburg, Germany; L. Ge, EMO, Centro Cuore Columbus; G. Sangiorgi, EMO, Centro Cuore Columbus; N. Corvaja, Centro Cuore Columbus; A. Colombo, EMO, Centro Cuore Columbus. Background: Restenosis after paclitaxel-eluting stent (PES) implantation is a rare phenomenon. The purpose of this study was to describe the angiographic patterns of restenosis after PES implantation in an unselected cohort of consecutive patients.
SEPTEMBER 30, 2004
TCT ABSTRACTS/Poster
THURSDAY 9/30/04 10:30
AM–12:30 PM
(Hall D and E on Level 2)
Methods: From February 2003 to January 2004, we treated 848 patients (1159 lesions, 1448 stents) in 3 institutions. Results: Of the total sample, 25% of patients were diabetic and 78% of lesions were complex (B2 or C). Mean baseline lesion length was 16.68 ⫾ 12.14 mm, and mean stent length was 27.22 ⫾ 13.49 mm. Follow-up control (at 8 months) and ischemia-driven angiograms (⬎30 days postprocedure) were performed in 165 patients. Fifty-nine patients had angiographic restenosis (ⱖ50%) in 67 stented segments (stent and 5 mm proximal and distal to the stent). Mean length of restenotic lesions was 8.84 ⫾ 4.91 mm, with a range from 2.18 to 23.83 mm, the majority of the lesions being less than 15 mm in length (Figure). The values of 7.43 and 19.22 mm were identified as the final clusters of restenotic lesion length. Restenosis was found in the body of the stent in 15 (22%), in the body and edges in 33 (49%), and in the edges only in 19 (29%) lesions. The pattern of restenosis in 36 (54%) lesions was focal (ⱕ10 mm in length) or multifocal and in 31 (46%) diffuse (⬎10 mm in length; 15 of the 27 cases of diffuse restenosis were total occlusions).
Methods: In the TAXUS II study, 536 patients were randomized to control or TAXUS; IVUS was performed postprocedure at 6 months. In a blinded post hoc analysis of all postprocedure IVUS films, stent expansion was categorized as “optimal” or “suboptimal.” Optimal stent expansion was defined as the absence of incomplete stent apposition, in-stent lumen area ⬎90% of the mean reference lumen area and ⬎100% of the distal reference area. Clinical outcomes and the primary study end point, percent net volume obstruction at 6 months, were compared between groups. Results: Optimal stent expansion was observed in 49% of all control and 49% of all TAXUS patients. In both groups, patients with suboptimal stent expansion had a statistically smaller RVD (p ⬍0.05). In the TAXUS group, optimal stent expansion was statistically more often achieved in younger patients (p ⫽ 0.02) of male gender (p ⫽ 0.01). Suboptimal stent expansion was more prominent in diabetics (p ⫽ 0.02). As expected, in control patients suboptimal stent expansion was associated with significantly higher 6-month percent net volume obstruction (25.0 ⫾ 18.0% vs 18.3 ⫾ 16.3%, p ⫽ 0.0058). In contrast, in TAXUS patients, suboptimal stent expansion was not associated with any increase in percent net volume obstruction (7.9 ⫾ 10.0% vs 7.2 ⫾ 9.7%, p ⫽ 0.58). Conclusions: This study confirms the association of suboptimal stent expansion and more luminal obstruction in lesions treated with bare-metal stents, but this relationship could not be demonstrated with TAXUS, indicating that the paclitaxel-eluting stent is more “forgiving.” To further validate this concept, a prospective assessment in more complex lesions is needed.
TCT-462
Conclusions: Restenosis after PES implantation in unselected lesions occurs more commonly in a focal pattern and in the majority (78%) of the cases involves the stent edges. Among diffuse restenotic lesions, most are below 15 mm in length.
TCT-461 Impact of Adequate Stent Expansion on Angiographic Restenosis with Polymer-Based Paclitaxel-Eluting TAXUS Stents: Post Hoc Analysis from the TAXUS II Study. F. Schiele, Centre Hospitalier Universitaire Jean Minjoz; S. Silber, Herzkatheterlabor Internistische Klinik Dr. Muller; A. Banning, John Radcliffe Hospital; K.E. Hauptmann, Krankenhaus der Barmherzigen Bruder; J. Drzewiecki, Samodzielny Publiczny Szpital Kliniczny Nr 7; E. Grube, Krankenhaus Siegburg GmbH; M.E. Russell, Boston Scientific Corporation; J. Koglin, Boston Scientific Corporation. Background: The impact of intravascular ultrasound (IVUS) guidance on optimized stent placement is controversial. Although optimal stent placement and expansion has been shown to reduce restenosis and improve clinical outcomes with bare-metal stents, the usefulness for drug-eluting stents has not been explored. This study’s objective was to perform a post hoc analysis of the TAXUS II data, comparing the impact of optimal stent expansion in bare-metal stent controls and TAXUSTM (Boston Scientific, Natick, Massachusetts) on IVUS parameters of restenosis.
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Optimal Stent Implantation Pressure in the Drug-Eluting-Stent Era: Observations from The TAXUS IV Study. M.A. Kutcher, Wake Forest University School of Medicine; R.J. Applegate, Wake Forest University School of Medicine; J. Hermiller, St. Vincent’s Hospital, Indianapolis; D.A. Cox, Mid Carolina Cardiology, Charlotte, NC; C.D. O’Shaughnessy, Elyria Memorial Hospital, Elyria, OH; R. Feldman, MediQuest Research Group, Ocala, FL; A.S. Moak, Our Lady of Lourdes Medical Center, Camden, NJ; R. Smalling, Hermann Hospital, Houston, TX; R. Mehran, Cardiovascular Research Foundation, New York, NY; M.E. Russell, Boston Scientific, Natick, MA; S.G. Ellis, Cleveland Clinic Foundation; G.W. Stone, Cardiovascular Research Foundation, New York, NY. Background: By optimizing wall apposition and increasing stent expansion, high pressure balloon dilatation may improve long-term outcomes after implantation of bare-metal stents (BMS). Given the marked reduction in late loss with drug-eluting stents compared with BMS, it is uncertain whether high-pressure implantation techniques are necessary or beneficial with these devices. Methods: In TAXUS-IV, 1,314 patients with single de novo lesions 10 to 28 mm in length in 2.5- to 3.75-mm vessels were randomized to receive either a polymer-based slow-release paclitaxel-eluting TAXUS stent or an EXPRESS BMS. Recommended deployment pressure was at least 12 atm. Additional higher pressure dilatation was allowed at operator discretion. Clinical and angiographic results were examined in the TAXUS arm as a function of the maximum device pressure (MDP) in 3 groups; ⬍14 atm (n ⫽ 188), 14 to 16 atm (n ⫽ 194), and ⬎16 atm (n ⫽ 277). Results: The results appear in the Table. By multivariate analysis, MDP was an independent predictor of freedom from analysis segment restenosis in the TAXUS arm (odds ratio [95% CI] ⫽ 0.85 [0.72, 1.00], p ⫽ 0.04).
SEPTEMBER 30, 2004
TCT ABSTRACTS/Poster
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P O S T E R A B S T R A C T S
THURSDAY 9/30/04 10:30 TAXUS Stent MDP Groups
<14 atm
14–16 atm
>16 atm
p value
MDP (atm) Diabetes (%) RVD (mm) Lesion length (mm) Acute gain (mm) Poststent analysis segment diameter stenosis 9-month Angiographic Measures Late loss (mm), analysis segment Binary restenosis, in-stent Binary restenosis, analysis segment 1-year clinical outcomes Subacute thrombosis Target vessel revascularization Major adverse cardiac events
11.6 22.3% 2.63 13.11 1.13 20.8%
14.2 22.2% 2.75 13.32 1.33 19.4%
17.4 24.9% 2.84 13.56 1.43 18.1%
⬍0.0001 0.73 ⬍0.0001 0.75 ⬍0.0001 0.02
0.26
0.21
0.23
0.74
11.1%* 13.9%†
3.5% 5.9%
3.8% 6.1%
0.06 0.10
1.1% 10.2%† 14.9%*
0.0% 6.8% 10.4%
0.7% 5.4% 8.6%
0.39 0.16 0.11
*p ⬍0.04 vs ⬎16 atm. †P ⫽ 0.06 vs ⬎16 atm. Conclusions: Freedom from restenosis and late event-free survival are enhanced with implantation of paclitaxel-eluting TAXUS stents at ⱖ14 atm. These results emphasize the continued importance of high pressures to optimize drug-eluting stent deployment.
TCT-463
P O S T E R A B S T R A C T S
Importance of Intravascular Ultrasound Guidance for Stent Implantation in the Era of Drug-Eluting Stents. C.R. Costantini, C.O. Costantini, M.F. Santos, S.G. Tarbine, R.Z. Darwich, M. Bubna, M. Medeiros, M.R.P. Oliveira, E. Dombeck, G. Yared, M. Maranha˜ o, O. Garcia, L. Rubbini. Fundac¸ a˜ o Francisco Costantini.
AM–12:30 PM
(Hall D and E on Level 2)
TCT-464 Subacute Stent Thrombosis following Drug-Eluting Stent Implantation: Results from the Strategic Transcatheter Evaluation of New Therapies (STENT) Group. C.A. Simonton, The Sanger Clinic, PA, Charlotte, NC; B. Brodie, LeBauer Research, Greensboro, NC; B. Cheek, High Point Regional Hospital, High Point, NC; J. Hasan-Jones, Carolinas Medical Center; F. Krainin, McLeod Regional Medical Center, Florence, SC; J. McPherson, Saint Thomas Hospital, Nashville, TN; N. Powell, Greenville Hospital System, Greenville, SC; M. Quam, Carolinas Medical Center; M. Rinaldi, The Sanger Clinic, PA, Charlotte, NC; G. San, Greenville Hospital System, Greenville, SC; H. Walpole, Saint Thomas Hospital, Nashville, TN; B.H. Wilson, The Sanger Clinic, PA, Charlotte, NC. Background: Since approval in the United States of drug-eluting stents (DES) in May 2003, there has been little information on the true incidence of subacute stent thrombosis (SAT) following implantation of these stents in a broad patient population. Methods: The STENT Group represents a multicenter registry for percutaneous coronary intervention that has enrolled patients prospectively and consecutively since May 2003. The registry includes inhospital, 3-month, and 9-month clinical outcomes. Results: A total of 3858 procedures have been enrolled in this ongoing registry. Of these, 2272 have completed the 3-month time interval (85% of those eligible). The patient population with completed follow-up represents a real-world population with a mean age of 62.6 ⫾ 12 years; 66% were male, 74% had acute coronary syndrome, 11% had acute evolving myocardial infarction, and 31% had diabetes. DES procedures comprise 48% of the follow-up population; 25% are nonDES only procedures, 11% are no-stent procedures, and the remaining 16% are mixed-stent procedures. Adjudicated subacute stent thrombosis (SAT) rates are shown in the Table. Two patients suffering SAT died, for a mortality rate of 14%. Non-DES procedures were associated with a SAT rate of 0.9% compared with 0.6% in DES procedures.
Background: To assess the impact of intravascular ultrasound (IVUS) on drug-eluting stents (DES) implantation. Methods: Between May 2002 and April 2004, 284 consecutive patients with a formal indication for a percutaneous coronary intervention received at least 1 DES guided by IVUS. Quantitative coronary analysis (QCA) and IVUS measurements were compared for reference vessel diameter (RVD) and lesion length. QCA was performed by an independent angiographic core lab (Fukuoka Hospital, Japan). IVUS analysis was performed with the Echoplaque (Indec System). Results: There were 403 DES implanted (1.41 DES/patient). RVD was 2.68 ⫾ 0.36 mm by QCA and 2.98 ⫾ 0.21 mm by IVUS (p ⬍0.05 for QCA vs IVUS). Lesion length was 16.3 ⫾ 6 mm as assessed by QCA compared with 21.5 ⫾ 9 mm as assessed by IVUS (p ⬍0.05 for QCA vs IVUS). Stent diameter and length were selected by IVUS guidance in 79% of the interventions leading to a stent diameter of 3.03 ⫾ 1.5 and a stent length of 21.5 ⫾ 9.0. IVUS assessment poststent implantation led to stent reintervention with a larger balloon (3.22 ⫾ 0.4mm) in 24% of stents because of suboptimal stent expansion. Luminal area of 6.75 ⫾ 0.8 mm2 increased to 8.42 ⫾ 1.0 mm2 after DES reintervention (p ⬍0.001). Conclusions: In this prospective analysis of a single center, DES implantation with IVUS guidance was important for an adequate selection of DES diameter and length. Similarly, poststent implantation IVUS assessment allowed optimization of the procedure in 24% of DES regardless an optimal angiographic result. A prospective and randomized study is necessary to assess the impact of IVUS-guided DES implantation on clinical outcomes.
Can Stent/Lesion Length Ratio Influence the Edge Effect After Implantation of Drug-Eluting and Bare-Metal Stents? A Volumetric Intravascular Ultrasound Study. J.S. Mun˜ oz, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil; A. Abizaid, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil; M. Albertal, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil; F. Feres, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil; E.J. Ferreira, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil; A.S. Abizaid, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil; L.A. Mattos, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil; R. Staico, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil; G. Maldonado, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil; V.D. Vaz, Institute Dante Pazzanese of Cardiology, Sa˜ o
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DES
Total SAT
NON-DES
n
%
n
%
1089 7
48 0.6
575 5
25 0.9
Conclusions: In the first year since DES approval in the United States, subacute stent thrombosis appears to occur very infrequently, and at a similar rate to patients receiving non-DES stents.
TCT-465 (withdrawn) TCT-466
TCT ABSTRACTS/Poster
THURSDAY 9/30/04 10:30
AM–12:30 PM
(Hall D and E on Level 2)
Paulo, Brazil; M. Centemero, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil; A. Chaves, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil; L.F. Tanajura, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil; A. Sousa, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil; G.S. Mintz, Cardiovascular Research Foundation, New York, NY; J.E. Sousa, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil. Background: Different stent:lesion length ratios (SLLR) have been reported in various multicenter drug-eluting stent (DES) trials (SIRIUS 1.6 vs RAVEL 2.2). This may determine the “uncovered” stent edge plaque burden, which may contribute to edge restenosis. Our objective was to evaluate whether plaque dynamics at the stent edges differ in relation to the SLLR in both DES and bare-metal stents (BMS). Methods: A total of 158 patients with de novo native coronary lesions were successfully treated with sirolimus-eluting stent (SES; n ⫽ 83 patients) and bare-metal DuraflexTM stent (n ⫽ 75 patients) implantation. Each groups was divided into 2 subgroups according to the median SLLR: (SES group ⫽ SSLR ⬍1.79 [n ⫽ 40 patients] and ⱖ1.79 [n ⫽ 43 patients]) and (BMS group ⫽ SSLR ⬍1.52 [n ⫽ 37] and ⱖ1.52 [n ⫽ 38]). Volumetric intravascular ultrasound (IVUS) was performed immediately after the procedure and at 6-month follow-up, and 5-mm proximal and distal edges were analyzed. Results: The mean SLLR values of the SES and BMS groups were 1.78 ⫾ 0.19 (range 1.41–2.20) and 1.56 ⫾ 0.25 (range 1.12–2.25), respectively. There were no differences in clinical and lesion characteristics between the 2 subgroups within each group. IVUS analysis is shown in the Table.
SES, SLLR >1.79 (n ⴝ 43)
SES, SLLR <1.79 (n ⴝ 40) IVUS Analysis (mm3) Prox edge: lumen Prox edge: plaque Prox edge: vessel Distal edge: lumen Distal edge: plaque Distal edge: vessel In-stent IH*
⌬ (6 Months Post)
p
⌬ (6 Months Post)
p
4.6 ⫾ 14.6 2.7 ⫾ 8.1 7.2 ⫾ 18.5 3.8 ⫾ 10.8 ⫺0.9 ⫾ 12.9 2.7 ⫾ 18.5 2.1 ⫾ 4.2
0.05 0.04 0.02 0.03 0.7 0.4 —
0.9 ⫾ 10.1 1.8 ⫾ 11.4 2.6 ⫾ 14.0 2.8 ⫾ 12.3 0.4 ⫾ 8.3 3.5 ⫾ 17.2 3.7 ⫾ 6.1
0.5 0.3 0.2 0.1 0.7 0.2 —
Conclusions: This IVUS study revealed significant edge-lumen reduction (plaque growth and vessel shrinking) in the BMS group irrespective of SLLR. However, in the SES group, longer eluting-stents in relation to lesion length resulted in less plaque growth at 6-month follow-up, especially at the proximal edge. This supports the concept of stenting longer segments when implanting DES.
The American Journal of Cardiology姞
BMS, SLLR >1.52 (n ⴝ 38)
BMS, SLLR <1.52 (n ⴝ 37)
Prox edge: lumen Prox edge: plaque Prox edge: vessel Distal edge: lumen Distal edge: plaque Distal edge: vessel In-stent IH†
⌬ (6 Months Post)
p
⌬ (6 Months Post)
p
⫺5.7 ⫾ 11.2 2.7 ⫾ 8.2 ⫺4.5 ⫾ 14.5 ⫺3.3 ⫾ 7.5 1.4 ⫾ 5.9 ⫺1.9 ⫾ 10.8 46.5 ⫾ 21.2
0.003 0.04 0.06 0.01 0.001 0.3 —
⫺3.0 ⫾ 10.0 3.1 ⫾ 7.8 0.1 ⫾ 12.1 ⫺3.4 ⫾ 7.5 1.1 ⫾ 8.0 ⫺2.3 ⫾ 11.9 49.0 ⫾ 25.4
0.04 0.02 0.9 0.09 0.03 0.2 —
IH ⫽ Intimal hyperplasia. *p ⫽ NS vs SLLR ⱖ1.79. †p ⫽ NS vs SLLR ⱖ1.52.
TCT-467 Restenosis following Sirolimus-Eluting Stent Occurring at the Site of Poststenting Minimal Lumen Diameter. L. Ge, EMO Centro Cuore Columbus Hospital; I. Iakovou, EMO Centro Cuore Columbus Hospital; I. Michev, San Raffaele Hospital; A. Chieffo, San Raffaele Hospital; M. Montorfano, San Raffaele Hospital; F. Airoldi, San Raffaele Hospital; G.M. Sangiorgi, EMO Centro Cuore Columbus Hospital; N. Corvaja, EMO Centro Cuore Columbus Hospital; L. Finci, EMO Centro Cuore Columbus Hospital; A. Colombo, EMO Centro Cuore Columbus Hospital. Background: It has been shown that most restenotic lesions following sirolimus-eluting stent (SES) implantation occur at the stent margins or inside the stent. Although the reason for the first type of restenosis is usually incomplete lesion coverage, restenosis inside the stent has no clear explanation. Methods: We identified 36 consecutive patients (43 lesions) with in-stent restenosis (ISR) following SES implantation from April 2002 to April 2004. The distances between minimal lumen diameter (MLD) and a reference side branch were measured at pre- and postintervention, and at follow-up (pre-MLDdist; post-MLDdist, and rest-MLDdist). Results: Rest-MLDdist was significantly correlated with pre-MLDdist (r ⫽ 0.88, confidence interval [CI]: 0.75– 0.98, p ⬍0.001) and post-MLDdist (r ⫽ 0.95, CI: 0.84 – 0.98, p ⬍0.001). Post-MLDdist was significantly correlated with Pre-MLDdist (r ⫽ 0.86, CI: 0.72– 0.95, p ⬍0.001). Conclusions: The site of ISR following SES implantation locates mostly at the site of suboptimal results postintervention and at the site of the baseline MLD. Local factors affected by plaque mass leading to struts maldistribution with inhomogeneous drug delivery are likely to be elements that contribute to focal ISR.
SEPTEMBER 30, 2004
TCT ABSTRACTS/Poster
215E
P O S T E R A B S T R A C T S
AM–12:30 PM
(Hall D and E on Level 2)
Drug-Eluting Stents: Failures and Restenosis Thursday, September 30, 2004 10:30 AM-12:30 PM Hall D and E on Level 2 (Abstract nos. 456-467)
TCT-457
TCT-456 Clinical, Procedural, and Angiographic Predictors of Restenosis following Sirolimus-Stent Implantation at 8-Month Follow-Up. D. Orlic, Clinical center of Serbia, Belgrade, Serbia; E. Bonizzoni, EMO Centro Cuore Columbus, Milan, Italy; G. Stankovic, Clinical Center of Serbia, Belgrade, Serbia; A. Chieffo, San Rafaelle Hospital, Milan, Italy; F. Airoldi, San Rafaelle Hospital, Milan, Italy; I. Iakovou, EMO Centro Cuore Columbus, Milan, Italy; M. Ferraro, EMO Centro Cuore Columbus, Milan, Italy; G. Vitrella, San Rafaelle Hospital, Milan, Italy; I. Michev, San Rafaelle Hospital, Milan, Italy; G. Sangiorgi, EMO Centro Cuore Columbus, Milan, Italy; N. Corvaja, EMO Centro Cuore Columbus, Milan, Italy; A. Colombo, EMO Centro Cuore Columbus, Milan, Italy. Background: Less reduction in neointimal proliferation was reported in some subsets of patients (diabetics) with lesions (small vessels, long lesions, bifurcation lesions), indicating potential predictors of restenosis in sirolimus-eluting stents (SES; CYPHER, Cordis, a Johnson & Johnson company, Warren, NJ). This study was performed to determine independent predictors of angiographic and clinical restenosis after SES implantation in unselected lesions. Methods: From April 16, 2002, to August 1, 2003, 629 consecutive patients with 1279 lesions were treated with 1434 SES. We excluded from the study patients who had at least 1 of the following criteria: 1) major adverse cardiac event (death, myocardial infarction [MI] due to subacute SES thrombosis, repeat percutaneous coronary intervention [PCI], or coronary artery bypass graft [CABG]) within 30 days after the index procedure; 2) death or MI caused by late SES thrombosis between 1 and 8 months; 3) 2-step PCI; 4) paclitaxel or bare-metal stent implantation; 5) angiographic failure (final diameter stenosis ⱖ30% or TIMI flow ⬍3); or 6) clinically driven follow-up angiography between 1 and 6 months after the index procedure showing absence of restenosis. Eight-month clinical follow-up was completed in 536 patients (98.9% of eligible patients) at a mean time of 9.3 ⫾ 2.8 months. Angiographic follow-up was undertaken, as clinically driven or as routine suggested, at 8 months in 255 patients at a mean time of 8.0 ⫾ 2.8 months. Thus, 536 patients with 1107 lesions (1244 SES implanted) constituted the study group. Clinical, angiographic, and procedural variables were analyzed to determine independent predictors of angiographic (diameter stenosis ⱖ50%) and clinical (target lesion revascularization; TLR) restenosis at 8-month follow-up. Results: Angiographic restenosis was found in 71 patients (102 restenotic lesions) and clinical restenosis in 52 (9.6%) patients with 72 lesions (6.5%). Multivariate analysis revealed independent predictors of angiographic restenosis: stented segment length (odds ratio [OR] 1.04, 95% confidence interval [CI] 1.02–1.06, p ⫽ 0.0004), stented side branch of bifurcation lesion (OR 2.44, 95% CI 1.21– 4.93, p ⫽ 0.01), prior CABG (OR 2.03, 95% CI 1.12–3.66, p ⫽ 0.02), and in-stent
The American Journal of Cardiology姞
restenosis (ISR; OR 1.86, 95% CI 1.03–3.36, p ⫽ 0.04). Multivariate analysis identified predictors of TLR: ISR (OR 2.93, 95% CI 1.57– 5.45, p ⫽ 0.0007), prior CABG (OR 2.60, 95% CI 1.36 – 4.94, p ⫽ 0.004), stented side branch of bifurcation lesion (OR 2.10, 95% CI 1.13–3.89, p ⫽ 0.02), and stented segment length (OR 1.02, 95% CI 1.0004 –1.04, p ⫽ 0.045). Conclusions: In this study, stented segment length, in-stent restenosis, stented side branch of the bifurcation lesion, and prior CABG were identified as independent predictors of restenosis following SES implantation.
Drug-Eluting Stents and Patterns of In-Stent Restenosis. R. Mehran, S. Kesanakurthy, G.D. Dangas, S. Iyer, C. Spatareanu, N. Elliott, F. Bajraktari, J. Lander, A. Nikitina, I. Moussa, E. Kreps, M. Collins, J.W. Moses, G.W. Stone, M.B. Leon. The Cardiovascular Research Foundation and the Lenox Hill Heart and Vascular Institute, New York, NY. Background: The patterns and incidence of in-stent restenosis (ISR) after implantation of bare-metal stents have been well established. Drug-eluting stents (DES) profoundly suppress in-stent neointimal hyperplasia, the main pathological substrate for in-stent restenosis (ISR), and dramatically reduce clinical and angiographic restenosis. However, the patterns of ISR associated with the use of DES have not been studied systematically. Methods: Between April 2003 and February 2004, a total of 2,338 consecutive patients (mean age 61years, 62% male, 34% diabetics) having a total of 4,231 lesions underwent implantation of sirolimuseluting stents (CYPHERTM). Information on clinical outcomes was obtained by telephone interviews at 30 days and 6 months. Results: ISR occurred in 44 lesions in 39 patients. Of the 44 ISR lesions, 1 presented with diffuse ISR type II, 2 with diffuse ISR type III, 39 with focal type I, and 2 with total occlusion type IV. ISR lesions were treated by repeat stenting using CYPHER (37/44, 84%), repeat balloon alone (6/44, 13.6%), and 1 patient received a Heparin-coated stent (2.2%). In contrast to the previous 6 months (October 2002 to April 2003), 282 patients with 311 lesions were treated for ISR after bare-metal stents. This represents an 86% reduction in ISR cases at Lenox Hill Hospital for this 6-month period since DES approval. Conclusions: The use of CYPHER is associated with a major reduction in cases of ISR and a change in the pattern of ISR from diffuse (with bare-metal stents) to a focal, easier treatable pattern. These data support the important impact of DES in effectively treating CAD and changing the paradigm of PCI cases in catheterization laboratories, where DES are used in majority of cases.
TCT-458 Paclitaxel-Eluting Stents Reduce Need for Subsequent Coronary Artery Bypass Graft Surgery by Changing the Incidence and Pattern of Restenosis. R. Caputo, SJH Cardiology Associates; D.A. Cox, Mid Carolina Heart Institute; J.J. Popma, Brigham and Women’s Hospital; J. Hermiller, St. Vincent’s Hospital; C. O’Shaughnessy, Elyria Memorial Hospital; J.T. Mann, Wake Forest Medical; M. Turco, Washington Adventist Hospital; S.G. Ellis, Cleveland Clinic Foundation; G.W. Stone, Cardiovascular Research Foundation. Background: Target vessel failure following implantation of baremetal coronary stents (BMS) results in the need for coronary artery bypass graft surgery (CABG) at 1 year in 4% to 10% of patients. Whether drug-eluting stents reduce this adverse event is unknown.
SEPTEMBER 30, 2004
TCT ABSTRACTS/Poster
211E
P O S T E R A B S T R A C T S
THURSDAY 9/30/04 10:30 Methods: One year outcomes for 1,314 patients randomized to BMS vs paclitaxel-eluting stents (PES) in the TAXUS IV trial were examined. Results: In the overall group, target vessel revascularization/CABG at 1-year was required in 37 patients (2.8%), including 4.0% after BMS and 1.8% after PES (p ⬍0.0001). Multivariate predictors of CABG for the entire population at 1 year appear in the Table. Among patients randomized to PES, the only multivariate predictor for CABG was inability to deliver a study stent (p ⫽ 0.04). One-year major cardiac adverse events was lower with PES compared with BMS (10.8% vs 20.0%; p ⬍0.001) with no difference in the incidence of cardiac death or MI between groups. Compared with BMS, PES reduced the incidence of TVF from 19.4% to 10.0% (p ⬍0.001) and in-stent angiographic restenosis from 24.4% to 5.5% (p ⬍0.001). Moreover, the diffuse pattern of restenosis was reduced from 53.5% with the BMS to 13% with PES (p ⫽ 0.006). Among patients with restenosis, the mean lesion length was 9.49 ⫾ 4.5 mm after PES vs 14.79 ⫾ 8.21 mm after BMS (p ⫽ 0.0002). Moreover, a diffuse pattern of restenosis was observed in 63.3% in patients requiring CABG vs 6.2% in those not requiring CABG (p ⬍0.0001).
Multivariate Predictors for CABG
Hazard Ratio (95% CI)
p Value
BMS randomization LAD lesion location No study stents implanted Total stent length Reference vessel diameter
0.45 (0.22–0.92) 2.30 (1.16–4.58) 0.26 (0.07–0.99) 1.03 (1.00–1.07) 0.28 (0.13–0.60)
0.028 0.018 0.049 0.047 0.001
AM–12:30 PM
(Hall D and E on Level 2)
late loss of approximately 0.6 mm or in-stent late loss of 0.75 mm can be accommodated within stents of the size used before TLR exceeds 5%. Curves for smaller and larger vessels are shifted left and right, respectively, and will be presented. Simulation modeling suggests that a 50% increase in the variance of late loss for TAXUS patients would have increased TLR from about 3.8% to 7.4%, and an increase in rightward skewedness from 0.00 to 0.40 would have increased TLR from 3.8% to 5.7%.
CI ⫽ confidence ratio; LAD ⫽ left anterior descending coronary artery.
P O S T E R A B S T R A C T S
Conclusion: By reducing both the occurrence and severity of restenosis, the paclitaxel-eluting stent significantly enhances freedom from CABG at 1-year compared with a bare-metal stent.
TCT-459 What Is the Threshold for “Acceptable” Late Loss in the DrugEluting-Stent Era? Insights from the TAXUS IV Angiographic Substudy. S.G. Ellis, The Cleveland Clinic Foundation, Cleveland, OH; J.J. Popma, Brigham & Women’s Hospital, Boston MA; J.M. Lasala, Washington University, School of Medicine, St. Louis, MO.; J.J. Koglin, Cardiovascular Clinical Affairs, Boston Scientific, Natick, MA; D.A. Cox, Mid Carolina Cardiology, Charlotte, NC; J. Hermiller, St. Vincent’s Hospital, Indianapolis, IN; C. O’Shaughnessy, Elyria Memorial Hospital, Elyria, OH; J.T. Mann, WakeMed, Raleigh, NC; M. Turco, Washington Adventist Hospital, Tacoma Park, MD; R. Caputo, St. Joseph’s Hospital, Syracuse, NY; P. Bergin, Sacred Heart Medical Center, Eugene, OR; J. Greenberg, Florida Hospital, Orlando, FL; G.W. Stone, Cardiovascular Research Foundation, New York, NY. Background: Late lumen loss following coronary stenting has been used as a measure of stent performance and antirestenosis drug effectiveness. However, the relationship between late loss and its statistical distribution (heterogeneity of effect) to target lesion revascularization (TLR) in patient populations in the drug-eluting stent (DES) era is incompletely understood. Methods: We analyzed this relationship in 582 patients (de novo, native vessel lesions, reference diameter ⫽ 2.8 ⫾ 5mm, lesion length ⫽ 12 ⫾ 5 mm). Results: TLR was closely but nonlinearly related to both in-stent and analysis-segment late loss (c statistics ⫽ .92 and .93; see Figure). The inflection point on these curves suggests that an analysis segment
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Conclusions: Thus, both absolute late loss and the heterogeneity of response determine TLR in the DES era.
TCT-460 Mechanism and Angiographic Patterns of Restenosis after Paclitaxel-Eluting Stent Implantation. I. Iakovou, EMO, Centro Cuore Columbus; T. Schmidt, Department of Cardiology, Klinikum Siegburg Rhein-Sieg GmbH, Seigburg, Germany; F. Airoldi, San Raffaele Hospital; A. Chieffo, San Raffaele Hospital; E. Grube, Department of Cardiology, Klinikum Siegburg Rhein-Sieg GmbH, Seigburg, Germany; U. Gerckens, Department of Cardiology, Klinikum Siegburg Rhein-Sieg GmbH, Seigburg, Germany; L. Ge, EMO, Centro Cuore Columbus; G. Sangiorgi, EMO, Centro Cuore Columbus; N. Corvaja, Centro Cuore Columbus; A. Colombo, EMO, Centro Cuore Columbus. Background: Restenosis after paclitaxel-eluting stent (PES) implantation is a rare phenomenon. The purpose of this study was to describe the angiographic patterns of restenosis after PES implantation in an unselected cohort of consecutive patients.
SEPTEMBER 30, 2004
TCT ABSTRACTS/Poster
THURSDAY 9/30/04 10:30
AM–12:30 PM
(Hall D and E on Level 2)
Methods: From February 2003 to January 2004, we treated 848 patients (1159 lesions, 1448 stents) in 3 institutions. Results: Of the total sample, 25% of patients were diabetic and 78% of lesions were complex (B2 or C). Mean baseline lesion length was 16.68 ⫾ 12.14 mm, and mean stent length was 27.22 ⫾ 13.49 mm. Follow-up control (at 8 months) and ischemia-driven angiograms (⬎30 days postprocedure) were performed in 165 patients. Fifty-nine patients had angiographic restenosis (ⱖ50%) in 67 stented segments (stent and 5 mm proximal and distal to the stent). Mean length of restenotic lesions was 8.84 ⫾ 4.91 mm, with a range from 2.18 to 23.83 mm, the majority of the lesions being less than 15 mm in length (Figure). The values of 7.43 and 19.22 mm were identified as the final clusters of restenotic lesion length. Restenosis was found in the body of the stent in 15 (22%), in the body and edges in 33 (49%), and in the edges only in 19 (29%) lesions. The pattern of restenosis in 36 (54%) lesions was focal (ⱕ10 mm in length) or multifocal and in 31 (46%) diffuse (⬎10 mm in length; 15 of the 27 cases of diffuse restenosis were total occlusions).
Methods: In the TAXUS II study, 536 patients were randomized to control or TAXUS; IVUS was performed postprocedure at 6 months. In a blinded post hoc analysis of all postprocedure IVUS films, stent expansion was categorized as “optimal” or “suboptimal.” Optimal stent expansion was defined as the absence of incomplete stent apposition, in-stent lumen area ⬎90% of the mean reference lumen area and ⬎100% of the distal reference area. Clinical outcomes and the primary study end point, percent net volume obstruction at 6 months, were compared between groups. Results: Optimal stent expansion was observed in 49% of all control and 49% of all TAXUS patients. In both groups, patients with suboptimal stent expansion had a statistically smaller RVD (p ⬍0.05). In the TAXUS group, optimal stent expansion was statistically more often achieved in younger patients (p ⫽ 0.02) of male gender (p ⫽ 0.01). Suboptimal stent expansion was more prominent in diabetics (p ⫽ 0.02). As expected, in control patients suboptimal stent expansion was associated with significantly higher 6-month percent net volume obstruction (25.0 ⫾ 18.0% vs 18.3 ⫾ 16.3%, p ⫽ 0.0058). In contrast, in TAXUS patients, suboptimal stent expansion was not associated with any increase in percent net volume obstruction (7.9 ⫾ 10.0% vs 7.2 ⫾ 9.7%, p ⫽ 0.58). Conclusions: This study confirms the association of suboptimal stent expansion and more luminal obstruction in lesions treated with bare-metal stents, but this relationship could not be demonstrated with TAXUS, indicating that the paclitaxel-eluting stent is more “forgiving.” To further validate this concept, a prospective assessment in more complex lesions is needed.
TCT-462
Conclusions: Restenosis after PES implantation in unselected lesions occurs more commonly in a focal pattern and in the majority (78%) of the cases involves the stent edges. Among diffuse restenotic lesions, most are below 15 mm in length.
TCT-461 Impact of Adequate Stent Expansion on Angiographic Restenosis with Polymer-Based Paclitaxel-Eluting TAXUS Stents: Post Hoc Analysis from the TAXUS II Study. F. Schiele, Centre Hospitalier Universitaire Jean Minjoz; S. Silber, Herzkatheterlabor Internistische Klinik Dr. Muller; A. Banning, John Radcliffe Hospital; K.E. Hauptmann, Krankenhaus der Barmherzigen Bruder; J. Drzewiecki, Samodzielny Publiczny Szpital Kliniczny Nr 7; E. Grube, Krankenhaus Siegburg GmbH; M.E. Russell, Boston Scientific Corporation; J. Koglin, Boston Scientific Corporation. Background: The impact of intravascular ultrasound (IVUS) guidance on optimized stent placement is controversial. Although optimal stent placement and expansion has been shown to reduce restenosis and improve clinical outcomes with bare-metal stents, the usefulness for drug-eluting stents has not been explored. This study’s objective was to perform a post hoc analysis of the TAXUS II data, comparing the impact of optimal stent expansion in bare-metal stent controls and TAXUSTM (Boston Scientific, Natick, Massachusetts) on IVUS parameters of restenosis.
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Optimal Stent Implantation Pressure in the Drug-Eluting-Stent Era: Observations from The TAXUS IV Study. M.A. Kutcher, Wake Forest University School of Medicine; R.J. Applegate, Wake Forest University School of Medicine; J. Hermiller, St. Vincent’s Hospital, Indianapolis; D.A. Cox, Mid Carolina Cardiology, Charlotte, NC; C.D. O’Shaughnessy, Elyria Memorial Hospital, Elyria, OH; R. Feldman, MediQuest Research Group, Ocala, FL; A.S. Moak, Our Lady of Lourdes Medical Center, Camden, NJ; R. Smalling, Hermann Hospital, Houston, TX; R. Mehran, Cardiovascular Research Foundation, New York, NY; M.E. Russell, Boston Scientific, Natick, MA; S.G. Ellis, Cleveland Clinic Foundation; G.W. Stone, Cardiovascular Research Foundation, New York, NY. Background: By optimizing wall apposition and increasing stent expansion, high pressure balloon dilatation may improve long-term outcomes after implantation of bare-metal stents (BMS). Given the marked reduction in late loss with drug-eluting stents compared with BMS, it is uncertain whether high-pressure implantation techniques are necessary or beneficial with these devices. Methods: In TAXUS-IV, 1,314 patients with single de novo lesions 10 to 28 mm in length in 2.5- to 3.75-mm vessels were randomized to receive either a polymer-based slow-release paclitaxel-eluting TAXUS stent or an EXPRESS BMS. Recommended deployment pressure was at least 12 atm. Additional higher pressure dilatation was allowed at operator discretion. Clinical and angiographic results were examined in the TAXUS arm as a function of the maximum device pressure (MDP) in 3 groups; ⬍14 atm (n ⫽ 188), 14 to 16 atm (n ⫽ 194), and ⬎16 atm (n ⫽ 277). Results: The results appear in the Table. By multivariate analysis, MDP was an independent predictor of freedom from analysis segment restenosis in the TAXUS arm (odds ratio [95% CI] ⫽ 0.85 [0.72, 1.00], p ⫽ 0.04).
SEPTEMBER 30, 2004
TCT ABSTRACTS/Poster
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THURSDAY 9/30/04 10:30 TAXUS Stent MDP Groups
<14 atm
14–16 atm
>16 atm
p value
MDP (atm) Diabetes (%) RVD (mm) Lesion length (mm) Acute gain (mm) Poststent analysis segment diameter stenosis 9-month Angiographic Measures Late loss (mm), analysis segment Binary restenosis, in-stent Binary restenosis, analysis segment 1-year clinical outcomes Subacute thrombosis Target vessel revascularization Major adverse cardiac events
11.6 22.3% 2.63 13.11 1.13 20.8%
14.2 22.2% 2.75 13.32 1.33 19.4%
17.4 24.9% 2.84 13.56 1.43 18.1%
⬍0.0001 0.73 ⬍0.0001 0.75 ⬍0.0001 0.02
0.26
0.21
0.23
0.74
11.1%* 13.9%†
3.5% 5.9%
3.8% 6.1%
0.06 0.10
1.1% 10.2%† 14.9%*
0.0% 6.8% 10.4%
0.7% 5.4% 8.6%
0.39 0.16 0.11
*p ⬍0.04 vs ⬎16 atm. †P ⫽ 0.06 vs ⬎16 atm. Conclusions: Freedom from restenosis and late event-free survival are enhanced with implantation of paclitaxel-eluting TAXUS stents at ⱖ14 atm. These results emphasize the continued importance of high pressures to optimize drug-eluting stent deployment.
TCT-463
P O S T E R A B S T R A C T S
Importance of Intravascular Ultrasound Guidance for Stent Implantation in the Era of Drug-Eluting Stents. C.R. Costantini, C.O. Costantini, M.F. Santos, S.G. Tarbine, R.Z. Darwich, M. Bubna, M. Medeiros, M.R.P. Oliveira, E. Dombeck, G. Yared, M. Maranha˜ o, O. Garcia, L. Rubbini. Fundac¸ a˜ o Francisco Costantini.
AM–12:30 PM
(Hall D and E on Level 2)
TCT-464 Subacute Stent Thrombosis following Drug-Eluting Stent Implantation: Results from the Strategic Transcatheter Evaluation of New Therapies (STENT) Group. C.A. Simonton, The Sanger Clinic, PA, Charlotte, NC; B. Brodie, LeBauer Research, Greensboro, NC; B. Cheek, High Point Regional Hospital, High Point, NC; J. Hasan-Jones, Carolinas Medical Center; F. Krainin, McLeod Regional Medical Center, Florence, SC; J. McPherson, Saint Thomas Hospital, Nashville, TN; N. Powell, Greenville Hospital System, Greenville, SC; M. Quam, Carolinas Medical Center; M. Rinaldi, The Sanger Clinic, PA, Charlotte, NC; G. San, Greenville Hospital System, Greenville, SC; H. Walpole, Saint Thomas Hospital, Nashville, TN; B.H. Wilson, The Sanger Clinic, PA, Charlotte, NC. Background: Since approval in the United States of drug-eluting stents (DES) in May 2003, there has been little information on the true incidence of subacute stent thrombosis (SAT) following implantation of these stents in a broad patient population. Methods: The STENT Group represents a multicenter registry for percutaneous coronary intervention that has enrolled patients prospectively and consecutively since May 2003. The registry includes inhospital, 3-month, and 9-month clinical outcomes. Results: A total of 3858 procedures have been enrolled in this ongoing registry. Of these, 2272 have completed the 3-month time interval (85% of those eligible). The patient population with completed follow-up represents a real-world population with a mean age of 62.6 ⫾ 12 years; 66% were male, 74% had acute coronary syndrome, 11% had acute evolving myocardial infarction, and 31% had diabetes. DES procedures comprise 48% of the follow-up population; 25% are nonDES only procedures, 11% are no-stent procedures, and the remaining 16% are mixed-stent procedures. Adjudicated subacute stent thrombosis (SAT) rates are shown in the Table. Two patients suffering SAT died, for a mortality rate of 14%. Non-DES procedures were associated with a SAT rate of 0.9% compared with 0.6% in DES procedures.
Background: To assess the impact of intravascular ultrasound (IVUS) on drug-eluting stents (DES) implantation. Methods: Between May 2002 and April 2004, 284 consecutive patients with a formal indication for a percutaneous coronary intervention received at least 1 DES guided by IVUS. Quantitative coronary analysis (QCA) and IVUS measurements were compared for reference vessel diameter (RVD) and lesion length. QCA was performed by an independent angiographic core lab (Fukuoka Hospital, Japan). IVUS analysis was performed with the Echoplaque (Indec System). Results: There were 403 DES implanted (1.41 DES/patient). RVD was 2.68 ⫾ 0.36 mm by QCA and 2.98 ⫾ 0.21 mm by IVUS (p ⬍0.05 for QCA vs IVUS). Lesion length was 16.3 ⫾ 6 mm as assessed by QCA compared with 21.5 ⫾ 9 mm as assessed by IVUS (p ⬍0.05 for QCA vs IVUS). Stent diameter and length were selected by IVUS guidance in 79% of the interventions leading to a stent diameter of 3.03 ⫾ 1.5 and a stent length of 21.5 ⫾ 9.0. IVUS assessment poststent implantation led to stent reintervention with a larger balloon (3.22 ⫾ 0.4mm) in 24% of stents because of suboptimal stent expansion. Luminal area of 6.75 ⫾ 0.8 mm2 increased to 8.42 ⫾ 1.0 mm2 after DES reintervention (p ⬍0.001). Conclusions: In this prospective analysis of a single center, DES implantation with IVUS guidance was important for an adequate selection of DES diameter and length. Similarly, poststent implantation IVUS assessment allowed optimization of the procedure in 24% of DES regardless an optimal angiographic result. A prospective and randomized study is necessary to assess the impact of IVUS-guided DES implantation on clinical outcomes.
Can Stent/Lesion Length Ratio Influence the Edge Effect After Implantation of Drug-Eluting and Bare-Metal Stents? A Volumetric Intravascular Ultrasound Study. J.S. Mun˜ oz, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil; A. Abizaid, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil; M. Albertal, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil; F. Feres, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil; E.J. Ferreira, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil; A.S. Abizaid, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil; L.A. Mattos, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil; R. Staico, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil; G. Maldonado, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil; V.D. Vaz, Institute Dante Pazzanese of Cardiology, Sa˜ o
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DES
Total SAT
NON-DES
n
%
n
%
1089 7
48 0.6
575 5
25 0.9
Conclusions: In the first year since DES approval in the United States, subacute stent thrombosis appears to occur very infrequently, and at a similar rate to patients receiving non-DES stents.
TCT-465 (withdrawn) TCT-466
TCT ABSTRACTS/Poster
THURSDAY 9/30/04 10:30
AM–12:30 PM
(Hall D and E on Level 2)
Paulo, Brazil; M. Centemero, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil; A. Chaves, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil; L.F. Tanajura, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil; A. Sousa, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil; G.S. Mintz, Cardiovascular Research Foundation, New York, NY; J.E. Sousa, Institute Dante Pazzanese of Cardiology, Sa˜ o Paulo, Brazil. Background: Different stent:lesion length ratios (SLLR) have been reported in various multicenter drug-eluting stent (DES) trials (SIRIUS 1.6 vs RAVEL 2.2). This may determine the “uncovered” stent edge plaque burden, which may contribute to edge restenosis. Our objective was to evaluate whether plaque dynamics at the stent edges differ in relation to the SLLR in both DES and bare-metal stents (BMS). Methods: A total of 158 patients with de novo native coronary lesions were successfully treated with sirolimus-eluting stent (SES; n ⫽ 83 patients) and bare-metal DuraflexTM stent (n ⫽ 75 patients) implantation. Each groups was divided into 2 subgroups according to the median SLLR: (SES group ⫽ SSLR ⬍1.79 [n ⫽ 40 patients] and ⱖ1.79 [n ⫽ 43 patients]) and (BMS group ⫽ SSLR ⬍1.52 [n ⫽ 37] and ⱖ1.52 [n ⫽ 38]). Volumetric intravascular ultrasound (IVUS) was performed immediately after the procedure and at 6-month follow-up, and 5-mm proximal and distal edges were analyzed. Results: The mean SLLR values of the SES and BMS groups were 1.78 ⫾ 0.19 (range 1.41–2.20) and 1.56 ⫾ 0.25 (range 1.12–2.25), respectively. There were no differences in clinical and lesion characteristics between the 2 subgroups within each group. IVUS analysis is shown in the Table.
SES, SLLR >1.79 (n ⴝ 43)
SES, SLLR <1.79 (n ⴝ 40) IVUS Analysis (mm3) Prox edge: lumen Prox edge: plaque Prox edge: vessel Distal edge: lumen Distal edge: plaque Distal edge: vessel In-stent IH*
⌬ (6 Months Post)
p
⌬ (6 Months Post)
p
4.6 ⫾ 14.6 2.7 ⫾ 8.1 7.2 ⫾ 18.5 3.8 ⫾ 10.8 ⫺0.9 ⫾ 12.9 2.7 ⫾ 18.5 2.1 ⫾ 4.2
0.05 0.04 0.02 0.03 0.7 0.4 —
0.9 ⫾ 10.1 1.8 ⫾ 11.4 2.6 ⫾ 14.0 2.8 ⫾ 12.3 0.4 ⫾ 8.3 3.5 ⫾ 17.2 3.7 ⫾ 6.1
0.5 0.3 0.2 0.1 0.7 0.2 —
Conclusions: This IVUS study revealed significant edge-lumen reduction (plaque growth and vessel shrinking) in the BMS group irrespective of SLLR. However, in the SES group, longer eluting-stents in relation to lesion length resulted in less plaque growth at 6-month follow-up, especially at the proximal edge. This supports the concept of stenting longer segments when implanting DES.
The American Journal of Cardiology姞
BMS, SLLR >1.52 (n ⴝ 38)
BMS, SLLR <1.52 (n ⴝ 37)
Prox edge: lumen Prox edge: plaque Prox edge: vessel Distal edge: lumen Distal edge: plaque Distal edge: vessel In-stent IH†
⌬ (6 Months Post)
p
⌬ (6 Months Post)
p
⫺5.7 ⫾ 11.2 2.7 ⫾ 8.2 ⫺4.5 ⫾ 14.5 ⫺3.3 ⫾ 7.5 1.4 ⫾ 5.9 ⫺1.9 ⫾ 10.8 46.5 ⫾ 21.2
0.003 0.04 0.06 0.01 0.001 0.3 —
⫺3.0 ⫾ 10.0 3.1 ⫾ 7.8 0.1 ⫾ 12.1 ⫺3.4 ⫾ 7.5 1.1 ⫾ 8.0 ⫺2.3 ⫾ 11.9 49.0 ⫾ 25.4
0.04 0.02 0.9 0.09 0.03 0.2 —
IH ⫽ Intimal hyperplasia. *p ⫽ NS vs SLLR ⱖ1.79. †p ⫽ NS vs SLLR ⱖ1.52.
TCT-467 Restenosis following Sirolimus-Eluting Stent Occurring at the Site of Poststenting Minimal Lumen Diameter. L. Ge, EMO Centro Cuore Columbus Hospital; I. Iakovou, EMO Centro Cuore Columbus Hospital; I. Michev, San Raffaele Hospital; A. Chieffo, San Raffaele Hospital; M. Montorfano, San Raffaele Hospital; F. Airoldi, San Raffaele Hospital; G.M. Sangiorgi, EMO Centro Cuore Columbus Hospital; N. Corvaja, EMO Centro Cuore Columbus Hospital; L. Finci, EMO Centro Cuore Columbus Hospital; A. Colombo, EMO Centro Cuore Columbus Hospital. Background: It has been shown that most restenotic lesions following sirolimus-eluting stent (SES) implantation occur at the stent margins or inside the stent. Although the reason for the first type of restenosis is usually incomplete lesion coverage, restenosis inside the stent has no clear explanation. Methods: We identified 36 consecutive patients (43 lesions) with in-stent restenosis (ISR) following SES implantation from April 2002 to April 2004. The distances between minimal lumen diameter (MLD) and a reference side branch were measured at pre- and postintervention, and at follow-up (pre-MLDdist; post-MLDdist, and rest-MLDdist). Results: Rest-MLDdist was significantly correlated with pre-MLDdist (r ⫽ 0.88, confidence interval [CI]: 0.75– 0.98, p ⬍0.001) and post-MLDdist (r ⫽ 0.95, CI: 0.84 – 0.98, p ⬍0.001). Post-MLDdist was significantly correlated with Pre-MLDdist (r ⫽ 0.86, CI: 0.72– 0.95, p ⬍0.001). Conclusions: The site of ISR following SES implantation locates mostly at the site of suboptimal results postintervention and at the site of the baseline MLD. Local factors affected by plaque mass leading to struts maldistribution with inhomogeneous drug delivery are likely to be elements that contribute to focal ISR.
SEPTEMBER 30, 2004
TCT ABSTRACTS/Poster
215E
P O S T E R A B S T R A C T S