- Email: [email protected]
Drug Eluting Stent Restenosis
http://files.abstractsonline.com/SUP WomensConfLogo.jpg
WEDNESDAY 10/18/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) Drug Eluting Stent Restenosis Exhibit Halls A and B Wednesday, October 19, 2005, 9:00 am - 5:00 pm (Abstract Nos. 475-490) TCT-475 Evaluation of Neointimal Hyperplasia by Optical Coherence Tomography at Six Month after Sirolimus Eluting Stent Deployment Daisuke Matsumoto, Daisuke Matsumoto, Junya Shite, Toshiro Shinke, Satoshi Watanabe, Toru Ozawa, Hiromasa Otake, Oscar Luis Paredes, Yusuke Tanino, Daisuke Ogasawara, Mitsuhiro Yokoyama Kobe University Hospital, Kobe, Japan BACKGROUND: Sirolimus eluting stent (SES) inhibits neointimal hyperplasia and has a risk of late stent thrombosis. Our aim is to evaluate the neointimal coverage on SES struts at chronic phase using optical coherence tomography(OCT). METHODS:OCT was performed for 13 stents (9 patients)six month after intravascular ultrasound (IVUS) guided implantation of SES. Whole SES were observed by OCT and the thickness of neointima on struts was measured by every 1mm cross section and were compared with IVUS image. RESULTS:At implantation, all SES were seemed well-apposed by IVUS. At 6month later, no restenosis was found by angiography. Among 1371 struts observed by OCT by 1mm cross section, 1206 struts are well-apposed with neointima, 135 struts are well-apposed without neointima and 62 struts are 28 at malapposition(12 at stent overlapped and 14 at calcified site). Average neointimal growth was 65.4μm. Average neointimal thickness of calcified leision was 55.7 μm and average neointimal thickness of non-calcified leision was 68.5 μm. CONCLUSION:Struts malapposition of SES were observed at stent overlapped and at calcified site. Neointimal hyperplasia was more prominent at non-calcified leision than calcified leision 6 month after SES deployment.
P O S T E R A B S T R A C T S
TCT-476 Intravascular Ultrasonic Predictors of Angiographic Restenosis after Sirolimus-Eluting Stent Implantation Myeong-Ki Hong, Cheol Whan Lee, Young-Hak Kim, Bong-Ki Lee, DukHyun Kang, Sang-Sig Cheong, Jae-Kwan Song, Jae-Joong Kim, SeongWook Park, Seung-Jung Park Asan Medical Center, Seoul, Republic of Korea It is clinically important to estimate the expected restenosis rate in various lesions subsets of different characteristics. Using intravascular ultrasound (IVUS), we evaluated the predictors of angiographic restenosis after sirolimus-eluting stent (SES) implantation in native lesions. IVUS-guided SES implantation and 6-month follow-up angiogram was performed in 449 patients with 543 lesions. Results were evaluated using conventional (clinical, angiographic, and IVUS) methodology. The overall angiographic restenosis rate of SES implantation was 3.9% (21/ 543). Using multivariate logistic regression analysis, the independent predictors of angiographic restenosis were the IVUS stent area (odds ratio=0.584, 95% CI 0.3850.885, p=0.011) and total stent length (odds ratio=1.028, 95% CI 1.002-
186H
1.055, p=0.038). The angiographic restenosis rate according to stent area and stent length is shown in Table. Angiographic restenosis rate (%) according to post-intervention stent area and stent length. Stent CSA (mm2) Stent length < 5.0 5.0< < 7.0 7.0 < P Total (mm) 21/543 (3.9) 12/129 (9.3%) 8/ 233 (3.4) 1/ 181 (0.6) <0.001 Total <20 1/ 152 (0.7) 0/ 19 (0.0) 1/ 66 (1.5) 0/ 67 (0.0) 0.519 20 < <33 1/ 166 (0.6) 1/ 33 (3.0) 0/ 74 (0.0) 0/ 59 (0.0) 0.132 > 33 19/ 225 (8.4) 11/ 77 (14.3) 7/ 93 (7.5) 1/ 55 (1.8) 0.036 P 0.001 0.056 0.018 0.316
TCT-477 Clinical and Angiographic Predictors of Restenosis after Drug-Eluting Stent Implantation in Long Atherosclerotic Lesions with Small Coronary Arteries Moo Hyun Kim1, Soon Jun Hong2, Tae Hoon Ahn3, Jang Ho Bae4, Young Keun Ahn5, Wan Joo Shim2, Young Moo Ro2, Do-Sun Lim2 1 Donga University Hospital, Pusan, Republic of Korea2Korea University Hospital, Seoul, Republic of Korea3Gachon University Hospital, Incheon, Republic of Korea4Konyang University Hospital, Daejeon, Republic of Korea5Chonnam University Hospital, Kwangju, Republic of Korea Background: Although drug-eluting stents (DES) have reduced the rate of restenosis, patients with long diffuse lesions in addition to small vessels are at an increased risk for in-stent restenosis after DES implantation. We investigated the predictors of restenosis after DES implantation in long atherosclerotic lesions with small coronary arteries. Methods and Results: Stented patients (n=278) with DESs were retrospectively reviewed for inclusion in the study from the PCI database. Patients with either sirolimus-eluting stent implantation (SES, n=212) (Cypher®, Cordis, Johnson & Johnson Corp., Miami, Florida) or paclitaxeleluting stent implantation (PES, n=66) (Taxus®, Boston Scientific Corp., Natick, Massachusetts) with angiographic reference vessel diameter of <2.75mm and lesion length of > 15 mm were included. At six months follow-up, 42 patients (25 patients [11.8%] with SES vs. 17 patients [25.6%] with PES) showed binary restenosis within the lesion (restenosis of ≥ 50% diameter, including 5 mm vessel segments proximal and distal to stented segment). Baseline clinical and angiographic characteristics were similar except for greater percent diameter stenosis before DES implantation (79.8 ± 13.6% vs. 70.3 ± 26.1%, p=0.02) and smaller minimal luminal diameter after DES implantation (2.34 ± 0.41 mm vs. 2.43 ± 0.26 mm, p=0.05) in the restenosis group. Univariate predictors of restenosis were the use of PES implantation (odds ratios [OR] 2.595, 95% confidence interval [CI] 1.2995.183, p=0.007) and smaller vessel reference diameter (OR 0.592, 95% CI 0.361-0.970, p=0.038) and greater percent diameter stenosis (OR 1.024, 95% CI 1.002-1.046, p=0.029) before DES implantation. By stepwise multivariate logistic regression analysis, only greater percent diameter stenosis (OR 1.033, 95% CI 1.011-1.055, p=0.003) before DES implantation and the use of PES (OR 3.977, 95% CI 1.876-8.428, p<0.001) were associated with restenosis. Conclusion: Greater percent diameter stenosis before DES implantation and the use of PES are significant predictors of restenosis in long atherosclerotic lesions with small coronary arteries. TCT-478 Target Lesion Revascularization after Implantation of Sirolimus and Paclitaxel Eluting Stents Michael Maeng1, Lisette O. Jensen2, Per Thayssen2, Klaus Rasmussen3, Leif Thuesen1 1 Skejby Sygehus, Aarhus, Denmark2Odense University Hospital, Odense, Denmark3Aalborg Hospital, Aalborg, Denmark
The American Journal of Cardiology© OCTOBER 16-21, 2005 TCT ABSTRACTS/Poster
ine.com/SUPT/1/1602/
WEDNESDAY 10/18/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) Background: Recent studies have shown that sirolimus (Cypher™) and paclitaxel (Taxus™) eluting stents reduce restenosis after percutaneous coronary intervention (PCI). Further, randomized comparisons of these stents have shown more late loss in the Taxus ™ than in the Cypher™ stent in selected patients. The purpose of the present register study was to compare the clinical revascularization rate in Cypher™ and Taxus™ stents in unselected patients. Methods: We used the Western Denmark Heart Database to identify 4163 patients with 5955 lesions treated with a Cypher (n=3683 lesions) or Taxus (n=2272 lesions) stent from January 1, 2003 to May 18, 2004. All types of lesions were included. For each patient a number of clinical characteristics and procedural data were collected prospectively. Any re-admittance for one of these interventions was registered in the same database. The choice of stent was at the operator’s discretion. Reintervention was driven by clinical symptoms. The primary endpoint was target lesion revascularization (TLR) defined as either new PCI or CABG of the target lesion within 9 months from the index procedure. Results: The Cypher stent was implanted in longer lesions (16.6±10.0 mm vs. 15.4±8.8 mm, p<0.001) with the use of longer stents (19.7±9.3 mm vs. 19.0±8.6 mm, p<0.001). The Cypher stent was implanted in more patients with diabetes mellitus (58.3% vs. 41.7%, p=0.047). TLR within 9 months was performed in 2.2% of lesions treated with the Cypher stent and in 3.0% of lesions treated with the Taxus stent (odds ratio, 95% confidence interval: 1.39, 1.001 to 1.928; p=0.049). Conclusions: These registry data indicate that implantation of the two current commercially available drug-eluting stents are associated with a low risk of re-intervention and that the Cypher stent is associated with a lower TLR rate than the Taxus stent. TCT-479 Predictors of Target Lesion Revascularization after Drug-Eluting Stent Implantation: A Angiographic and Intravascular Ultrasound of the TAXUS IV and VI Studies Esteban Escolar1, Gary S. Mintz2, Joerg Koglin3, Lam Peter3, Jeffrey J. Popma4, Mary Russell3, Stephen G. Ellis5, Gregg W. Stone2, Eberhard Grube6, Keith Dawkins7, Neil J. Weissman1 1 Washington Hospital Center, Washington, DC;2Cardiovascular Research Fundation, New York, NY;3Boston Scientific, Boston, MA;4Brigham and Women’s Hospital, Boston, MA;5Cleveland Clinic, Cleveland, OH;6Heart Center, Siegburg, Germany7Southampton University Hospital, Southampton, United Kingdom Intravascular ultrasound (IVUS) and quantitative coronary angiographic (QCA) measures of restenosis have been used to assess drug eluting stent (DES) effectiveness. We performed a sub-analysis of TAXUS IV and VI to determine which parameter correlated best with target lesion revascularization (TLR) Method: We analyzed the subset of 112 TAXUS stents (68 from TAXUS IV and 44 from TAXUS VI) and 107 control bare metal stents (BMS) (68 TAXUS IV and 39 TAXUS VI) with complete post-intervention and follow-up (FU) IVUS and QCA. By IVUS, stent and intimal hyperplasia (IH) area and IH thickness (each degree for 360°) were measured every mm throughout the stent; and maximum IH thickness per mm and per stent and %volume obstruction (IH/stent volume) were calculated. By QCA, in-stent late lumen loss (LLL) and FU %diameter stenosis (DS) were calculated. Results: ROC curves combining all patients (TAXUS and BMS) were plotted, and the areas under the curve (AUC) were calculated (Table). The best predictor of TLR (6.2% overall) was the FU QCA %DS. IVUS maximum IH thickness was a better predictor of TLR than %volume obstruction, but both were weaker predictors of TLR than either QCA parameter. Conclusion: In DES trials QCA %DS should be used as the best surrogate of clinical restenosis (TLR).
ROC - c statistics (AUC) 0.911 0.889 0.783 0.692
QCA In-stent %DS QCA In-stent LLL IVUS Maximum IH Thickness IVUS %Volume Obstruction
TCT-480 Intimal Hyperplasia Thickness is Independent of Stent Size in Paclitaxel Polymer Coated (TAXUS) Stents Esteban Escolar1,2, Gary S. Mintz3, Joerg Koglin4, Peter Lam4, Jeffrey J. Popma5, Mary Russell4, Stephen G. Ellis6, Gregg W. Stone3, Eberhard Grube7, Keith Dawkins8, Neil J. Weissman1,2 1 Washington Hospital Center, Washington, DC;2Cardiovascular Research Institute, Washington, DC;3Cardiovascular Research Fundation, New York, NY;4Boston Scientific, Boston, MA;5Brigham and Women’s Hospital, Boston, MA;6Cleveland Clinic, Cleveland, OH;7Heart Center, Seigburg, Germany8Southampton University Hospital, Southampton, United Kingdom Intravascular ultrasound studies have shown that intimal hyperplasia (IH) thickness is independent of stent size in bare metal and non-polymer coated paclitaxel stents. This study extends these observations to polymer-coated (TAXUS) paclitaxel stents. Methods. We analyzed the subset of 112 TAXUS (68 from TAXUS IV and 44 from TAXUS VI) and 107 control (68 TAXUS IV and 39 TAXUS VI) stents with complete post-intervention and follow-up IVUS and angiography. IH thickness was measured each degree (for 360°) and every mm throughout the stent. Maximum (Max) IH thickness was calculated and correlated with stent size. The data was analyzed in terciles according to QCA reference vessel diameter (QCA RD). Results. There was a weak correlation between Max IH thickness and mean stent area for TAXUS (r=0.23 p=0.01) and for controls (r=0.32, p=0.0012). When stents were analyzed according to QCA RD terciles (Table), Max IH thickness was similar among the groups for both TAXUS and control pts; and Max IH was thinner in TAXUS than control pts independent of stent size. Conclusion. IH thickness is independent of stent size in polymeric paclitaxelcoated stents, similar to bare metal stents and non-polymeric paclitaxel coated stents. These findings are consisted across QCA reference vessel sizes. Table.
TAXUS (per stent) Max IH Thickness (mm) Control (per stent) Max IH Thickness (mm)
QCA Reference vessel size <2.5 mm 2.5-3.00 mm
>3.00 mm
P (ANOVA)
0.38±0.38
0.40 ± 0.35
0.50±0.43
0.23
0.7±0.31
0.67± 0.32
0.81±0.39
0.11
TCT-481 Impact of Lesion Length on Angiographic Outcomes in Patients with Small Coronary Arteries Treated with the 2.25 Sirolimus-Eluting BX VelocityTM Stent Jeffrey W Moses1, Eugenia Nikolsky1, Patrick Cambier2, Bill Bachinsky3, Charles O’Shaughnessy4, Roxana Mehran1, Fred Leya5, Rick Kuntz6, Sidney A Cohen7, Paul Tierstein8, Shing Chiu Wong9, Martin B Leon1 1 Columbia University Medical Center, New York, NY;2Morton Plant Hospital, Clearwater, FL;3Harrisburg Hospital, Harrisburg, PA;4North Ohio Heart Center, Eylria, OH;5Loyola University Medical Center, Chicago, IL;66Brigham and Women’s Hospital, Boston, MA;7Cordis Corporation, Warren, NJ;8Scripps Clinic and Research, La Jolla, CA;9New York Presbyterian Hospital, New York, NY Background: Longer lesion length (LL) is one of the determinants of in-stent restenosis, even in the drug-eluting stent era. Impact of LLon outcomes of pts with small vessels treated with sirolimus-eluting stents (SES) is poorly understood.
The American Journal of Cardiology© OCTOBER 16-21, 2005 TCT ABSTRACTS/Poster
187H
P O S T E R A B S T R A C T S
WEDNESDAY 10/18/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) Aim: We assessed the impact of LL on angiographic and clinical outcome after implantation of the 2.25 SES for the treatment of a single native coronary artery lesion (vessel diameter 2.0-2.5mm, LL<20mm). Methods and Results: Pts from the prospective SIRIUS-2.25mm registry were divided into tertiles of target LL (Table). Pts with longer LL had higher prevalence of diabetes, longer total stent length, more stents per lesion and more overlapping stents (p value 0.03 to <0.0001). Inhospital MACE were not related to LL (0%, 6.3% and 0% for 1st to 3rd tertiles, respectively; p=0.12). At 6-month angiographic FU available for 82 pts (84.5%) [Table], longer LL was associated with greater instent/in-lesion late loss and higher rates of binary restenosis. 6-month TLR tended to be higher in pts with longer LL. There were 2 cases of stent thrombosis (in 1st and 3rd tertiles). Longer LL was an independent predictor of 6-month in-stent late loss (p=0.009) while implantation of >1 stent/lesion was an independent predictor of TLR (p=0.034). Conclusion: Despite the efficacy of SES in reducing restenosis compared with bare metal stents, even in smaller vessels treated with 2.25mm SES, longer LL and use of multiple stents may still be important predictors for restenosis and repeat revascularization. Lesion length (mm) 2nd tertile 1st tertile 3rd tertile (>8.66 to (<8.66mm) (>13.4mm) <13.4mm) n=32 n=33 n=32 6.35±1.35 10.35±1.19 19.53±7.22
P value
Lesion length, mm <0.0001 Angiographic outcome In-lesion late loss, mm 0.18±0.39 0.18±0.27 0.36±0.55 0.19 In-stent late loss, mm 0.26±0.49 0.28±0.31 0.51±0.65 0.12 In-lesion binary restenosis, % 7.7 14.8 27.6 0.13 In-stent binary restenosis, % 7.7 3.7 24.1 0.045 Clinical outcome Death, % 3.6 0 0 0.32 MI, % 2.4 5.0 8.3 0.60 TLR, % 0 0 12.6 0.024 MACE*, % 3.6 0 12.6 0.089 *MACE=death, myocardial infarction (MI), emergent CABG and target lesion revascularization (TLR).
TCT-482
P O S T E R A B S T R A C T S
Restenosis after Sirolimus Stent Implantation: A Rare but Challenging Condition. Data from Real-World Experience Massimo Fineschi, Tommaso Gori, Carlo Pierli, Stefano Casini, Giuseppe Sinicropi, Alberto Buti, Achille Bravi U.O.Emodinamica Azienda Ospedaliera -Universitaria Senese, Siena, Italy Background: Sirolimus eluting stents (SES) have dramatically reduced the incidence of in-stent restenosis, but a small percentage of patients still requires repeat revascularization. Little information is available regarding angiographic characteristics and clinical presentation of in-SES restenosis. As well, there is no controlled trial to show the superiority of one particular treatment strategy over another. Methods and results: The incidence of clinically-driven target lesion revascuarization due to in-SES restenosis in our laboratory is 2.2% (27 lesions in 25 patients out of 1424 SES implanted in 1159 patients between may 2002 and december 2004) at a follow-up of 6-36 months. Patients with in-SES restenosis presented at 10±5 (range 4-23) months for stable angina (n=15), acute myocardial infarction (n=3), unstable angina (n=7). Two patients had restenosis in 2 separate SES. Predictors of restenosis included diabetes, treatment of chronic total occlusion, geographic miss and stent underexpansion. The angiographic pattern of in-SES restenosis was type Ia (gap between two SES, 1 case), Ib (focal margin: proximal edge in 7 cases, distal in 3), Ic (focal body of SES, 9 cases), type II (diffuse, 1 case), type III (proliferative, 1 case) and type IV (totally occlusive, 5 cases). The first 20 patients were treated with the following strategy: type Ic in-SES restenosis with balloon-only angioplasty (8 lesions, 7 patients), while other patterns of restenosis with repeat drug eluting
188H
stent implantation (13 lesions, 12 patients). Reintervention failed only in one case (type IV restenosis). Clinical and angiographic follow-up data were obtained from all patients at least 9 months after treatment of in-SES restenosis and will be presented at Scientific Sessions. Conclusions: Restenosis after SES occurs more commonly in a focal pattern and in the majority of the cases involves the body or the proximal edge of the stent. We report data on the outcome of a treatment strategy adjusted according to the type of lesion (balloon angioplasty for focal body SES restenosis, restenting for all other patterns). TCT-483 Focal Sirolimus-Eluting Stent Restenosis: An Emerging Problem Gloria Melzi1, John Cosgrave2, Giuseppe Biondi-Zoccai1, Alaide Chieffo1, Flavio Airoldi1, Ioannis Iakovou2, Giuseppe M. Sangiorgi2, Iassen Michev1, Matteo Montorfano1, Antonio Colombo3 1 San Raffaele Hospital, Milano, Italy2Emo Centro Cuore Columbus, Milano, Italy3San Raffaele Hospital and Emo Centro Cuore Columbus, Milano, Italy Background: While sirolimus-eluting stent (SES) restenosis is uncommon, the optimum management remains to be defined. We assessed the hypothesis that POBA and repeat drug-eluting stent (DES) implantation would have similar outcomes in the treatment of focal SES restenosis. Methods: Our study population comprised all consecutive patients who underwent reintervention for focal (defined as <10 mm) SES restenosis between November 2002 and July 2004. Results: Seventy-five patients (89 lesions) were included: 35 (39.3%) lesions were treated with POBA and 54 (60.7%) with DES implantation. No patients were lost to clinical follow-up. Forty-three (57.3%) patients underwent angiographic follow-up and the rate of angiographic followup was the same in both groups. At follow-up (mean 14.5±6.7 months) there were no cases of myocardial infarction and 2 (2.5%) cardiac deaths, both in the POBA treatment group. Target vessel revascularization (TVR) occurred in 15 (16.9%) lesions and target lesion revascularization (TLR) in 13 (14.6%) lesions. When the outcome was analysed according to the treatment of the restenotic lesion, TLR occurred in 6 (17.1%) lesions in the POBA group and 7 (13%) in the DES group (p 0.76). Conclusions: Overall the treatment of focal SES restenosis is associated with favourable early and mid-term results in this challenging cohort of patients. These preliminary data demonstrate no clear advantages for any of modalities analysed. Thus POBA is likely the most cost-effective treatment of focal SES-restenosis. TCT-484 A New and Simple Risk Score to Predict Target Vessel Revascularization After Coronary Stenting Alexandre S Quadros, Carlos A M Gottschall, Rogério Sarmento-Leite Institute of Cardiology of Rio Grande do Sul / FUC, Porto Alegre, RS, Brazil Background: The TIMI risk score has gained wide clinical acceptance not only because of its discriminatory ability to stratify high and low risk patients with unstable angina, but also because it is a simple and easy to use clinical tool. However, reported models of a new target vessel revascularization (TVR) after coronary stenting are complicated and have not been incorporated in daily practice. Objective: We sought to develop a simple predictive score for the possibility of a new TVR after coronary stenting based on preprocedural variables. Methods: Clinical and angiographic characteristics of a prospective cohort of 848 consecutive patients (pts) submitted to 895 bare metal stent implantations were included in a dedicated database. Excluded from the study were those with unsuccessful procedures or residual stenosis>30%.
The American Journal of Cardiology© OCTOBER 16-21, 2005 TCT ABSTRACTS/Poster
WEDNESDAY 10/18/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) Independent predictors of 1-year TVR were identified by multivariate analysis, and the Hosmer-Lemeshow goodness-of-fit test was used to choose the model which most appropriately fit the data. The score points were assigned according to the relative risk ratio of 1-year TVR. Results: The mean age of our sample was 60±10.8 years, and 28.4% were women. Diabetes mellitus was present in 23 % of the pts, and 76% had an acute coronary syndrome. The mean reference vessel diameter was 3.3±0.4 mm, and the mean lesion length was 10.14±10.7 mm. The 1-year TVR rate in the 848 pts was 7.4%. By multivariate analysis, the reference vessel diameter, the lesion length and the presence of diabetes mellitus were retained in the final model (Hosmer-Lemeshow goodness-of-fit test=2.339; p=0.969). The increase of 1-year TVR rates was almost linear with each score level (0 = 1.4%, 1 = 4.5%, 2 = 7.1%, 3 = 10,4% and 4/5 = 15.7%; r =0.90; p < 0.001). The c-statistic was 0.64, similar to the TIMI risk score. Conclusions: The score herein described stratifies patients with high and low risk for a new TVR after bare metal stent implantation. It can be used as a simple clinical tool for the prediction of a new revascularization procedure in daily practice. TCT-485 Incidence and Predictors of Restenosis after Drug-Eluting Stents Placement in Real-World Patients Cheol Whan Lee, Duk-Woo Park, Bong-Ki Lee, Young-Hak Kim, MyeongKi Hong, Jae-Joong Kim, Seong-Wook Park, Seung-Jung Park Asan Medical Center, Seoul, Republic of Korea Background: Drug-eluting stents (DES) has been increasingly used in a wide variety of clinical and anatomic situations. However, data are limited regarding the predictors of DES failure in unselected lesions. Methods: We investigated the incidences and predictors of restenosis after DES implantation in routine clinical practice. A total of 1,795 consecutive patients underwent successful implantation of sirolimus-eluting (1,374 patients, 1,788 lesions) or paclitaxel-eluting (421 patients, 517 lesions) stents between Feb 2003 and Nov 2004. Of the 1,743 ligible patients (2,221 lesions), follow-up angiography at 6 months was obtained at 70.5% (1,228 patients, 1.577 lesions).All data were prospectively recorded and analyzed for the ability to predict the occurrence of restenosis defined as a diameter stenosis ≥50%. Results: Restenosis was documented in 125 patients with 138 lesions (8.8%) and target lesion revascularization was required in 70 patients with 82 lesions (5.2%). The pattern of restenosis was 85 focal (62%), 29 diffuse (21%), 11 diffuse proliferative (8%) and 13 total (9%). Lesion length, stent length, final minimal lumen diameter, preintervention minimal lumen diameter, reference artery size, complex lesions, and use of paclitaxel-eluting stent were univariate predictors of restenosis. In multivariate analysis, however, use of paclitaxel-eluting stent (OR 4.37, 95%CI 2.90-6.58, p<0.001), post-intervention final minimal lumen diameter (OR 0.32, 95%CI 0.20-0.50, p<0.001) and lesion length (OR 1.02, 95%CI 1.01-1.04, p<0.001) were independent predictors of restenosis. Conclusions: Restenosis after DES implantation in “real-world” patients was similar to the rate reported in clinical trials, confirming the efficacy of using the DES in routine clinical practice.
but not in the proximal segment. Whether distal coronary vasomotor functions might be affected by proximal DES implant has not been determined. In this study, we investigated in-stent NI, as well as vasomotor function distal sites of bare metal (BM), polyurethanecoated (PLU) and DES (Cypher) stent implant after one month. BM, PLU and Cypher stents were implanted in pig coronary arteries (stent: artery = 1.15:1) and the hearts were harvested at 4 weeks. Stented segments of vessels were analyzed by histomorphometry; arterial segments <2 cm distal to the stents were studied in an organ-chamber apparatus (BM=7, PLU=5 & Cypher=6). Endothelium-dependent (EDR) and -independent relaxation (EIDR) and contraction responses to classical agonists were investigated. NI thickness of Cypher was significantly less than BM & PLU (0.18±0.04 vs. 0.31±0.06 & 0.62±0.3mm; P<0.05). The in-stent luminal area for Cypher was higher (4.87±0.27 vs. 3.37±0.25 & 2.31±0.41mm2; P<0.05). NI area was also smaller in Cypher than in PLU (P<0.05). In the presence of L-NAME, the ratio of contractions elicited by endothelin-1/ KCl of distal to the stents segments was greater for Cypher than for BM & PLU (1.67±0.15 vs. 1.15±0.03 and 1.17±0.07%; P<0.05). The maximal dose of EDR to substance P in Cypher was less than BM & PLU (46.4±5.9 vs. 77.5±2.2 & 77.9±3.1%; P<0.05). The maximal EDR to Ca++ ionophore A23187 for Cypher was decreased (64.9±8.5 vs. 86.4±5.3 in BM & 81.8±3.9% in PLU; P=0.068). The maximal dose of EIDR to sodium nitroprusside for Cypher was higher than BM & PLU (100±4.7 vs. 69.4±7.1 & 77.1±4.6%; P<0.05). Cypher stent profoundly inhibits in-stent NI at one month post-implant in pig coronary arteries compared to bare metal. Alterations in the vasomotor function of the distal conduit artery were observed in parallel to this effect, including augmented contractile and EIDR, as well as decreased EDRs responses. These observations suggest that distal vascular spasm may be induced by elution of rapamycin from DES at 4 weeks and contribute to pathophysiological events such as abrupt closure. TCT-487 IVUS Guidance Stenting in Long De Novo Coronary Lesions is Not Associated with Improved Clinical Outcomes in Drug-Eluting Stent Era Chul-Min Ahn, Young-Guk Ko, Jaemin Shim, Jeong Geun Moon, Jin-Bae Kim, Tae-Soo Kang, Jong-Youn Kim, Sungha Park, Donghoon Choi, Yangsoo Jang, Won-Heum Shim, Seung-Yun Cho Cardiology Division, Yonsei Cardiovascular Center, Yonsei University College of Medicine, Seoul, Republic of Korea Background: The purpose of this study was to evaluate efficacy and clinical outcomes of intravascular ultrasound (IVUS)-guided stenting for the treatment of long coronary lesions in drug eluting stent (DES) era. Methods: Since January/03 to September/04, 64 long lesions (>25mm) in 58 patients treated with IVUS-guided DES implantation and 208 long lesions (>25mm) in 200 patients treated with angiography-guided DES implantation were enrolled. Primary end points were death, myocardial infarction, or ischemia-driven target vessel revascularization within 9 months of index stent procedure. Results: The baseline characteristics and clinical outcomes between 2 groups were similar. (Table)
TCT-486 Inhibition of Neointima Formation is Associated with Aberrant Endothelium-Dependent Relaxation Distal to Site of DES (Cypher) Implant in Pig Coronary Arteries Jinsheng Li, Yoritaka Otsuka, Stephen P. Mulkey, Keith A Robinson, Nicolas A F Chronos American Cardiovascular Research Institute, Norcross, GA Drug-eluting stents (DESs) have been shown to reduce neointima formation (NI) in the distal coronary segment downstream to the stent
The American Journal of Cardiology© OCTOBER 16-21, 2005 TCT ABSTRACTS/Poster
189H
P O S T E R A B S T R A C T S
WEDNESDAY 10/18/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) IVUS-guided (n=64) Age yrs 63.2 ± 9.3 Male.(%) 44 (69%) DM (%) 20 (31%) Hypertension (%) 36 (56%) Renal failure (%) 4 (6%) Hypercholesterolemia(%) 19 (30% ) Non-MI/MI(%). 51/13 ( 80%/ 20%) 60/30 ( 67%/ 33%) Cypher/Taxus stent (%) Overlapping stents (%) 25 (39%) Lesion Length (%) 35.2 ± 9.85 PreRD/PostRD (%) 2.90 ± 0.47/ 2.98 ± 0.45 PreMLD/PostMLD (%) 0.57 ± 0.39/ 2.62 ± 0.48 Acute gain (%) 2.05 ± 0.61 FU RD/MLD(%) 2.81 ± 0.35/ 2.37 ± 0.63 Late loss - 9 months (%) 0.32 ± 0.65 (n=29/64) In-stent restenosis (%) 4 (13%) (n=29/64) 30 days MACE (%) 0 (0%) 9 months MACE (%) 4 (6.3%) Death (%) 0 (0%) MI (%) 0 (0%) TVR (%) 4 (6.3%)
PAngio-guided(n=208) value 61.43 ± 10.2 NS 148 (71%) NS 85 (40%) NS 131 (62%) NS 28 (13%) NS 53 (25%) NS 156/53 ( 75% /25%) NS 258/64 ( 80%/ 20%) NS 94 (45%) NS 35.9 ± 12.99 NS 2.85 ± 0.44/ 2.91 ± 0.45 NS 0.56 ± 0.46/ 2.58 ± 0.49 NS 2.01 ± 0.62 NS 2.85 ± 0.44/ 2.35 ± 0.57 NS 0.26 ± 0.65 (n=114/208) NS 11 (9%) (n=114/208) NS 1 (0.5%) NS 13 (6.2%) NS 2 (0.9%) NS 1 (0.5%) NS 10 (4.8%) NS
Conclusions: Clinical outcomes of IVUS-guided stenting for the treatment of long de novo coronary lesions in DES era is not superior to those of angiography-guided stenting. These data suggest that the routine performance of IVUS during long lesion intervention in DES era does not improve angiographic and clinical outcome at 9 months. TCT-488 Histopathologic Features of Restenotic Lesions within Drug- Eluting Stents in Humans Alaide Chieffo1, Chiara Foglieni1, Laura Rota Nodari1, Carlo Briguori2, Gloria Melzi1, Matteo Montorfano1, Giuseppe Sangiorgi1, Alessio Giazzon1, Anton E Becker1, Antonio Colombo1, Attilio Maseri1 1 San Raffaele Scientific Institute, Milan, Italy2Clinica Mediterranea, Naples, Italy
P O S T E R A B S T R A C T S
Drug-eluting stents (DES) are associated with a lower rate of in-stent restenosis (ISR). Features about neo-intimal tissue involved in restenosis after either sirolimus- (SES) or paclitaxel-eluting stent (PES) implantation are still scanty. Methods From October 2004 to May 2005 8 pts previously treated with DES (4 PES, 4 SES) underwent directional atherectomy for ISR after 4 to 13 months. Morphology was evaluated on sections from 5 pts by Movat’s stain. Confocal microscopy was performed in all 8 pts, assessing the proliferation rate by Ki67 and inflammatory cells (lymphocytes, granulocytes, macrophages) by CD3 and CD18. Smooth muscle cells (SMC) were characterized by alpha-SM actin (SMA), Factin, myosin heavy chain type 1 - 2 (Mhc) and Collagen type I (Coll). Endothelial cells were assessed by VE-cadherin, CD34 and CD31. Results A focal restenosis was found by angiography in 7 out of 8 DES ISR. In all pts histology showed that restenotic lesions were mainly composed of intimal-media tissue, with polymer residues and fibro-lipidic areas. Confocal microscopy confirmed histology, showing prevalence of SMCs with a synthetic phenotype, absence of both inflammatory cells and endothelial lining. On serial sections sparse Ki67 positive cells were identified as SMCs. SMCs expressed SMA and F-actin in all restenotic lesions. Distinctive features between SES and PES were: 1) mean proliferation index: 0,85 % in SES, 0,41% in PES; 2) a lower expression of Mhc and Coll in SES than in PES; 3) several Mhc negative areas were observed in all PES, but not in SES; 4) no endothelial cells were detected in PES, whereas small clusters of CD 31/VE-cadherin or CD31/CD34 double positive cells were present in SES tissues, far from the polymer. Conclusions: Intra-DES restenotic tissue is mainly composed by SMCs of a synthetic phenotype, still proliferating up to 13-months follow-up. Cell phenotype differences between PES and SES, proliferation features and incomplete endothelialization are under investigation. These preliminary results suggest different mechanisms of restenosis in the two DES types. These findings may have relevant implications for the optimal duration of anti-platelets pts therapy for different types of DES.
190H
TCT-489 Long-term Outcomes of Repeat Revascularization for Treatment of Drug-Eluting Stent Restenosis Bong-Ki Lee, Seong-Wook Park, Duk-Woo Park, Kyoung-Ha Park, MiJeong Kim, Bong-Ryong Choi, Il-Woo Suh, Young-Hak Kim, Cheol Whan Lee, Myeong-Ki Hong, Jae-Joong Kim, Seung-Jung Park Asan Medical Center, Seoul, Republic of Korea Background: Outcomes of various treatment approaches for restenosis of drug-eluting stent (DES) are not well known. Methods: This study included 1,835 patients with 2,352 lesions who underwent percutaneous coronary interventions using sirolimus-eluting stents (SES, 1,856 lesions) or paclitaxel-eluting stents (PES, 488 lesions) from February 2003 to September 2004. Results: Restenosis in analysis segment was documented in 68 lesions (5.5%) of the SES group and 63 lesions (19.9%) of the PES group (p<0.001). In lesions with restenosis, 70% of the SES group and 50% of the PES group were found as a focal restenotic pattern (p=0.02). Target lesion revascularization (TLR) was performed in 23 patients (1.6%) with 24 lesions of the SES group and 27 patients (6.9%) with 35 lesions of the PES group (p<0.001). For treatment of restenosis, cutting balloon angioplasty for focal restenosis was performed in 6 lesions (10.2 %). SES implantation was used in 11 (45.8 %) and 16 (45.7 %) restenoses in the SES and PES groups, respectively. PES implantation was performed in 1 (4.2 %) restenosis of the SES group. Intracoronary brachytherapy was used in 6 (25.0 %) and 7 (20.0 %) diffuse restenoses in the SES and PES group, respectively. Bypass surgery was performed in 3 (12.5%) SES and 6 (17.1%) PES patients. During follow-up period (median, 11.5 months), death, myocardial infarction or stent thrombosis did not occur in patients with TLR. Recurrent restenosis was documented in 4 (12.5%) lesions (1 after cutting balloon angioplasty and 3 after brachytherapy) from 32 eligible lesions. Repeat TLR was performed in 2 recurrent restenoses including SES implantation for one patient after cutting balloon angioplasty and bypass surgery for one patient after coronary brachytherapy. Conclusion: Repeat revascularization with DES appears to be a safe and effective treatment approach for treatment of drug-eluting stent restenosis. TCT-490 Multibiomarker Measurement for the Prediction of One-Year FollowUp after Elective PCI; A New Benchmark for Clinical Outcome? Saskia Z H Rittersma1, Pascalle S Monraats2, J Wouter Jukema2, Aeilko H Zwinderman1, Moniek P M de Maat3, Pieter A F Doevendans4, Rene A Tio5, Arnoud van der Laarse2, Jan G P Tijssen1, Jan P van Straalen1, Johan Fischer1, Robbert J de Winter1 1 Academic Medical Center, Amsterdam, The Netherlands2Leiden University Medical Center, Leiden, The Netherlands3Erasmus Medical Center, Rotterdam, The Netherlands4University Medical Center, Utrecht, The Netherlands5University Medical Center, Groningen, The Netherlands Background: Baseline biomarker levels may be useful in risk stratification for target vessel revascularization (TVR) and for the prediction of long-term clinical outcome. However, little is known about the use of a multibiomarker strategy in patients treated non-urgently with PCI. Methods: The GENDER project, a multicenter prospective study, included consecutive patients after successful PCI and was designed to study the predictive value of various risk factors for clinical restenosis (TVR) or the combined endpoint of death, myocardial infarction andTVR (MACE). Baseline plasma samples were available in 1325 patients, in whom off-line analysis of CRP, NT-proBNP, Creatinine and cardiac Troponin t (cTnT) was performed. Results: Median follow-up duration was 11 months (IQR 8.9-13.5). During follow-up, TVR occurred in 155 patients (11.7%), MI in 20 (1.5%), cardiac death in 17 (1.3%), noncardiac death in 8 (0.6%);
The American Journal of Cardiology© OCTOBER 16-21, 2005 TCT ABSTRACTS/Poster
WEDNESDAY 10/18/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) MACE occurred in 184 patients (13.9%). Elevated biomarkers were not associated with TVR, but individual biomarkers were predictive for allcause mortality. Multivariate stepwise Cox regression analysis showed that age >65 years (Hazard ratio [HR] 3.2, 95% CI 1.1-8.9) and elevated NT-proBNP (HR 4.4, 95% CI 1.7-11.0) were independent predictors for mortality. There was no relationship between the number of elevated biomarkers and TVR, MI or MACE. However, the number of elevated biomarkers corresponded positively to the risk of death (P = 0.001). Comparison between the 2 participating centers showed no differences in mortality in each group stratified to the number of elevated biomarkers. Conclusions: Elevated NT-proBNP is a strong independent risk factor for 1-year mortality after non-urgent PCI. A multibiomarker strategy with CRP, NT-proBNP, Creatinine and cTnT provides additional prognostic information for the risk of death after PCI and may be useful in daily practice as a benchmark for the comparison of PCI centers.
P O S T E R A B S T R A C T S
The American Journal of Cardiology© OCTOBER 16-21, 2005 TCT ABSTRACTS/Poster
191H
WEDNESDAY 10/18/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) Drug Eluting Stent Restenosis Exhibit Halls A and B Wednesday, October 19, 2005, 9:00 am - 5:00 pm (Abstract Nos. 475-490) TCT-475 Evaluation of Neointimal Hyperplasia by Optical Coherence Tomography at Six Month after Sirolimus Eluting Stent Deployment Daisuke Matsumoto, Daisuke Matsumoto, Junya Shite, Toshiro Shinke, Satoshi Watanabe, Toru Ozawa, Hiromasa Otake, Oscar Luis Paredes, Yusuke Tanino, Daisuke Ogasawara, Mitsuhiro Yokoyama Kobe University Hospital, Kobe, Japan BACKGROUND: Sirolimus eluting stent (SES) inhibits neointimal hyperplasia and has a risk of late stent thrombosis. Our aim is to evaluate the neointimal coverage on SES struts at chronic phase using optical coherence tomography(OCT). METHODS:OCT was performed for 13 stents (9 patients)six month after intravascular ultrasound (IVUS) guided implantation of SES. Whole SES were observed by OCT and the thickness of neointima on struts was measured by every 1mm cross section and were compared with IVUS image. RESULTS:At implantation, all SES were seemed well-apposed by IVUS. At 6month later, no restenosis was found by angiography. Among 1371 struts observed by OCT by 1mm cross section, 1206 struts are well-apposed with neointima, 135 struts are well-apposed without neointima and 62 struts are 28 at malapposition(12 at stent overlapped and 14 at calcified site). Average neointimal growth was 65.4μm. Average neointimal thickness of calcified leision was 55.7 μm and average neointimal thickness of non-calcified leision was 68.5 μm. CONCLUSION:Struts malapposition of SES were observed at stent overlapped and at calcified site. Neointimal hyperplasia was more prominent at non-calcified leision than calcified leision 6 month after SES deployment.
P O S T E R A B S T R A C T S
TCT-476 Intravascular Ultrasonic Predictors of Angiographic Restenosis after Sirolimus-Eluting Stent Implantation Myeong-Ki Hong, Cheol Whan Lee, Young-Hak Kim, Bong-Ki Lee, DukHyun Kang, Sang-Sig Cheong, Jae-Kwan Song, Jae-Joong Kim, SeongWook Park, Seung-Jung Park Asan Medical Center, Seoul, Republic of Korea It is clinically important to estimate the expected restenosis rate in various lesions subsets of different characteristics. Using intravascular ultrasound (IVUS), we evaluated the predictors of angiographic restenosis after sirolimus-eluting stent (SES) implantation in native lesions. IVUS-guided SES implantation and 6-month follow-up angiogram was performed in 449 patients with 543 lesions. Results were evaluated using conventional (clinical, angiographic, and IVUS) methodology. The overall angiographic restenosis rate of SES implantation was 3.9% (21/ 543). Using multivariate logistic regression analysis, the independent predictors of angiographic restenosis were the IVUS stent area (odds ratio=0.584, 95% CI 0.3850.885, p=0.011) and total stent length (odds ratio=1.028, 95% CI 1.002-
186H
1.055, p=0.038). The angiographic restenosis rate according to stent area and stent length is shown in Table. Angiographic restenosis rate (%) according to post-intervention stent area and stent length. Stent CSA (mm2) Stent length < 5.0 5.0< < 7.0 7.0 < P Total (mm) 21/543 (3.9) 12/129 (9.3%) 8/ 233 (3.4) 1/ 181 (0.6) <0.001 Total <20 1/ 152 (0.7) 0/ 19 (0.0) 1/ 66 (1.5) 0/ 67 (0.0) 0.519 20 < <33 1/ 166 (0.6) 1/ 33 (3.0) 0/ 74 (0.0) 0/ 59 (0.0) 0.132 > 33 19/ 225 (8.4) 11/ 77 (14.3) 7/ 93 (7.5) 1/ 55 (1.8) 0.036 P 0.001 0.056 0.018 0.316
TCT-477 Clinical and Angiographic Predictors of Restenosis after Drug-Eluting Stent Implantation in Long Atherosclerotic Lesions with Small Coronary Arteries Moo Hyun Kim1, Soon Jun Hong2, Tae Hoon Ahn3, Jang Ho Bae4, Young Keun Ahn5, Wan Joo Shim2, Young Moo Ro2, Do-Sun Lim2 1 Donga University Hospital, Pusan, Republic of Korea2Korea University Hospital, Seoul, Republic of Korea3Gachon University Hospital, Incheon, Republic of Korea4Konyang University Hospital, Daejeon, Republic of Korea5Chonnam University Hospital, Kwangju, Republic of Korea Background: Although drug-eluting stents (DES) have reduced the rate of restenosis, patients with long diffuse lesions in addition to small vessels are at an increased risk for in-stent restenosis after DES implantation. We investigated the predictors of restenosis after DES implantation in long atherosclerotic lesions with small coronary arteries. Methods and Results: Stented patients (n=278) with DESs were retrospectively reviewed for inclusion in the study from the PCI database. Patients with either sirolimus-eluting stent implantation (SES, n=212) (Cypher®, Cordis, Johnson & Johnson Corp., Miami, Florida) or paclitaxeleluting stent implantation (PES, n=66) (Taxus®, Boston Scientific Corp., Natick, Massachusetts) with angiographic reference vessel diameter of <2.75mm and lesion length of > 15 mm were included. At six months follow-up, 42 patients (25 patients [11.8%] with SES vs. 17 patients [25.6%] with PES) showed binary restenosis within the lesion (restenosis of ≥ 50% diameter, including 5 mm vessel segments proximal and distal to stented segment). Baseline clinical and angiographic characteristics were similar except for greater percent diameter stenosis before DES implantation (79.8 ± 13.6% vs. 70.3 ± 26.1%, p=0.02) and smaller minimal luminal diameter after DES implantation (2.34 ± 0.41 mm vs. 2.43 ± 0.26 mm, p=0.05) in the restenosis group. Univariate predictors of restenosis were the use of PES implantation (odds ratios [OR] 2.595, 95% confidence interval [CI] 1.2995.183, p=0.007) and smaller vessel reference diameter (OR 0.592, 95% CI 0.361-0.970, p=0.038) and greater percent diameter stenosis (OR 1.024, 95% CI 1.002-1.046, p=0.029) before DES implantation. By stepwise multivariate logistic regression analysis, only greater percent diameter stenosis (OR 1.033, 95% CI 1.011-1.055, p=0.003) before DES implantation and the use of PES (OR 3.977, 95% CI 1.876-8.428, p<0.001) were associated with restenosis. Conclusion: Greater percent diameter stenosis before DES implantation and the use of PES are significant predictors of restenosis in long atherosclerotic lesions with small coronary arteries. TCT-478 Target Lesion Revascularization after Implantation of Sirolimus and Paclitaxel Eluting Stents Michael Maeng1, Lisette O. Jensen2, Per Thayssen2, Klaus Rasmussen3, Leif Thuesen1 1 Skejby Sygehus, Aarhus, Denmark2Odense University Hospital, Odense, Denmark3Aalborg Hospital, Aalborg, Denmark
The American Journal of Cardiology© OCTOBER 16-21, 2005 TCT ABSTRACTS/Poster
ine.com/SUPT/1/1602/
WEDNESDAY 10/18/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) Background: Recent studies have shown that sirolimus (Cypher™) and paclitaxel (Taxus™) eluting stents reduce restenosis after percutaneous coronary intervention (PCI). Further, randomized comparisons of these stents have shown more late loss in the Taxus ™ than in the Cypher™ stent in selected patients. The purpose of the present register study was to compare the clinical revascularization rate in Cypher™ and Taxus™ stents in unselected patients. Methods: We used the Western Denmark Heart Database to identify 4163 patients with 5955 lesions treated with a Cypher (n=3683 lesions) or Taxus (n=2272 lesions) stent from January 1, 2003 to May 18, 2004. All types of lesions were included. For each patient a number of clinical characteristics and procedural data were collected prospectively. Any re-admittance for one of these interventions was registered in the same database. The choice of stent was at the operator’s discretion. Reintervention was driven by clinical symptoms. The primary endpoint was target lesion revascularization (TLR) defined as either new PCI or CABG of the target lesion within 9 months from the index procedure. Results: The Cypher stent was implanted in longer lesions (16.6±10.0 mm vs. 15.4±8.8 mm, p<0.001) with the use of longer stents (19.7±9.3 mm vs. 19.0±8.6 mm, p<0.001). The Cypher stent was implanted in more patients with diabetes mellitus (58.3% vs. 41.7%, p=0.047). TLR within 9 months was performed in 2.2% of lesions treated with the Cypher stent and in 3.0% of lesions treated with the Taxus stent (odds ratio, 95% confidence interval: 1.39, 1.001 to 1.928; p=0.049). Conclusions: These registry data indicate that implantation of the two current commercially available drug-eluting stents are associated with a low risk of re-intervention and that the Cypher stent is associated with a lower TLR rate than the Taxus stent. TCT-479 Predictors of Target Lesion Revascularization after Drug-Eluting Stent Implantation: A Angiographic and Intravascular Ultrasound of the TAXUS IV and VI Studies Esteban Escolar1, Gary S. Mintz2, Joerg Koglin3, Lam Peter3, Jeffrey J. Popma4, Mary Russell3, Stephen G. Ellis5, Gregg W. Stone2, Eberhard Grube6, Keith Dawkins7, Neil J. Weissman1 1 Washington Hospital Center, Washington, DC;2Cardiovascular Research Fundation, New York, NY;3Boston Scientific, Boston, MA;4Brigham and Women’s Hospital, Boston, MA;5Cleveland Clinic, Cleveland, OH;6Heart Center, Siegburg, Germany7Southampton University Hospital, Southampton, United Kingdom Intravascular ultrasound (IVUS) and quantitative coronary angiographic (QCA) measures of restenosis have been used to assess drug eluting stent (DES) effectiveness. We performed a sub-analysis of TAXUS IV and VI to determine which parameter correlated best with target lesion revascularization (TLR) Method: We analyzed the subset of 112 TAXUS stents (68 from TAXUS IV and 44 from TAXUS VI) and 107 control bare metal stents (BMS) (68 TAXUS IV and 39 TAXUS VI) with complete post-intervention and follow-up (FU) IVUS and QCA. By IVUS, stent and intimal hyperplasia (IH) area and IH thickness (each degree for 360°) were measured every mm throughout the stent; and maximum IH thickness per mm and per stent and %volume obstruction (IH/stent volume) were calculated. By QCA, in-stent late lumen loss (LLL) and FU %diameter stenosis (DS) were calculated. Results: ROC curves combining all patients (TAXUS and BMS) were plotted, and the areas under the curve (AUC) were calculated (Table). The best predictor of TLR (6.2% overall) was the FU QCA %DS. IVUS maximum IH thickness was a better predictor of TLR than %volume obstruction, but both were weaker predictors of TLR than either QCA parameter. Conclusion: In DES trials QCA %DS should be used as the best surrogate of clinical restenosis (TLR).
ROC - c statistics (AUC) 0.911 0.889 0.783 0.692
QCA In-stent %DS QCA In-stent LLL IVUS Maximum IH Thickness IVUS %Volume Obstruction
TCT-480 Intimal Hyperplasia Thickness is Independent of Stent Size in Paclitaxel Polymer Coated (TAXUS) Stents Esteban Escolar1,2, Gary S. Mintz3, Joerg Koglin4, Peter Lam4, Jeffrey J. Popma5, Mary Russell4, Stephen G. Ellis6, Gregg W. Stone3, Eberhard Grube7, Keith Dawkins8, Neil J. Weissman1,2 1 Washington Hospital Center, Washington, DC;2Cardiovascular Research Institute, Washington, DC;3Cardiovascular Research Fundation, New York, NY;4Boston Scientific, Boston, MA;5Brigham and Women’s Hospital, Boston, MA;6Cleveland Clinic, Cleveland, OH;7Heart Center, Seigburg, Germany8Southampton University Hospital, Southampton, United Kingdom Intravascular ultrasound studies have shown that intimal hyperplasia (IH) thickness is independent of stent size in bare metal and non-polymer coated paclitaxel stents. This study extends these observations to polymer-coated (TAXUS) paclitaxel stents. Methods. We analyzed the subset of 112 TAXUS (68 from TAXUS IV and 44 from TAXUS VI) and 107 control (68 TAXUS IV and 39 TAXUS VI) stents with complete post-intervention and follow-up IVUS and angiography. IH thickness was measured each degree (for 360°) and every mm throughout the stent. Maximum (Max) IH thickness was calculated and correlated with stent size. The data was analyzed in terciles according to QCA reference vessel diameter (QCA RD). Results. There was a weak correlation between Max IH thickness and mean stent area for TAXUS (r=0.23 p=0.01) and for controls (r=0.32, p=0.0012). When stents were analyzed according to QCA RD terciles (Table), Max IH thickness was similar among the groups for both TAXUS and control pts; and Max IH was thinner in TAXUS than control pts independent of stent size. Conclusion. IH thickness is independent of stent size in polymeric paclitaxelcoated stents, similar to bare metal stents and non-polymeric paclitaxel coated stents. These findings are consisted across QCA reference vessel sizes. Table.
TAXUS (per stent) Max IH Thickness (mm) Control (per stent) Max IH Thickness (mm)
QCA Reference vessel size <2.5 mm 2.5-3.00 mm
>3.00 mm
P (ANOVA)
0.38±0.38
0.40 ± 0.35
0.50±0.43
0.23
0.7±0.31
0.67± 0.32
0.81±0.39
0.11
TCT-481 Impact of Lesion Length on Angiographic Outcomes in Patients with Small Coronary Arteries Treated with the 2.25 Sirolimus-Eluting BX VelocityTM Stent Jeffrey W Moses1, Eugenia Nikolsky1, Patrick Cambier2, Bill Bachinsky3, Charles O’Shaughnessy4, Roxana Mehran1, Fred Leya5, Rick Kuntz6, Sidney A Cohen7, Paul Tierstein8, Shing Chiu Wong9, Martin B Leon1 1 Columbia University Medical Center, New York, NY;2Morton Plant Hospital, Clearwater, FL;3Harrisburg Hospital, Harrisburg, PA;4North Ohio Heart Center, Eylria, OH;5Loyola University Medical Center, Chicago, IL;66Brigham and Women’s Hospital, Boston, MA;7Cordis Corporation, Warren, NJ;8Scripps Clinic and Research, La Jolla, CA;9New York Presbyterian Hospital, New York, NY Background: Longer lesion length (LL) is one of the determinants of in-stent restenosis, even in the drug-eluting stent era. Impact of LLon outcomes of pts with small vessels treated with sirolimus-eluting stents (SES) is poorly understood.
The American Journal of Cardiology© OCTOBER 16-21, 2005 TCT ABSTRACTS/Poster
187H
P O S T E R A B S T R A C T S
WEDNESDAY 10/18/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) Aim: We assessed the impact of LL on angiographic and clinical outcome after implantation of the 2.25 SES for the treatment of a single native coronary artery lesion (vessel diameter 2.0-2.5mm, LL<20mm). Methods and Results: Pts from the prospective SIRIUS-2.25mm registry were divided into tertiles of target LL (Table). Pts with longer LL had higher prevalence of diabetes, longer total stent length, more stents per lesion and more overlapping stents (p value 0.03 to <0.0001). Inhospital MACE were not related to LL (0%, 6.3% and 0% for 1st to 3rd tertiles, respectively; p=0.12). At 6-month angiographic FU available for 82 pts (84.5%) [Table], longer LL was associated with greater instent/in-lesion late loss and higher rates of binary restenosis. 6-month TLR tended to be higher in pts with longer LL. There were 2 cases of stent thrombosis (in 1st and 3rd tertiles). Longer LL was an independent predictor of 6-month in-stent late loss (p=0.009) while implantation of >1 stent/lesion was an independent predictor of TLR (p=0.034). Conclusion: Despite the efficacy of SES in reducing restenosis compared with bare metal stents, even in smaller vessels treated with 2.25mm SES, longer LL and use of multiple stents may still be important predictors for restenosis and repeat revascularization. Lesion length (mm) 2nd tertile 1st tertile 3rd tertile (>8.66 to (<8.66mm) (>13.4mm) <13.4mm) n=32 n=33 n=32 6.35±1.35 10.35±1.19 19.53±7.22
P value
Lesion length, mm <0.0001 Angiographic outcome In-lesion late loss, mm 0.18±0.39 0.18±0.27 0.36±0.55 0.19 In-stent late loss, mm 0.26±0.49 0.28±0.31 0.51±0.65 0.12 In-lesion binary restenosis, % 7.7 14.8 27.6 0.13 In-stent binary restenosis, % 7.7 3.7 24.1 0.045 Clinical outcome Death, % 3.6 0 0 0.32 MI, % 2.4 5.0 8.3 0.60 TLR, % 0 0 12.6 0.024 MACE*, % 3.6 0 12.6 0.089 *MACE=death, myocardial infarction (MI), emergent CABG and target lesion revascularization (TLR).
TCT-482
P O S T E R A B S T R A C T S
Restenosis after Sirolimus Stent Implantation: A Rare but Challenging Condition. Data from Real-World Experience Massimo Fineschi, Tommaso Gori, Carlo Pierli, Stefano Casini, Giuseppe Sinicropi, Alberto Buti, Achille Bravi U.O.Emodinamica Azienda Ospedaliera -Universitaria Senese, Siena, Italy Background: Sirolimus eluting stents (SES) have dramatically reduced the incidence of in-stent restenosis, but a small percentage of patients still requires repeat revascularization. Little information is available regarding angiographic characteristics and clinical presentation of in-SES restenosis. As well, there is no controlled trial to show the superiority of one particular treatment strategy over another. Methods and results: The incidence of clinically-driven target lesion revascuarization due to in-SES restenosis in our laboratory is 2.2% (27 lesions in 25 patients out of 1424 SES implanted in 1159 patients between may 2002 and december 2004) at a follow-up of 6-36 months. Patients with in-SES restenosis presented at 10±5 (range 4-23) months for stable angina (n=15), acute myocardial infarction (n=3), unstable angina (n=7). Two patients had restenosis in 2 separate SES. Predictors of restenosis included diabetes, treatment of chronic total occlusion, geographic miss and stent underexpansion. The angiographic pattern of in-SES restenosis was type Ia (gap between two SES, 1 case), Ib (focal margin: proximal edge in 7 cases, distal in 3), Ic (focal body of SES, 9 cases), type II (diffuse, 1 case), type III (proliferative, 1 case) and type IV (totally occlusive, 5 cases). The first 20 patients were treated with the following strategy: type Ic in-SES restenosis with balloon-only angioplasty (8 lesions, 7 patients), while other patterns of restenosis with repeat drug eluting
188H
stent implantation (13 lesions, 12 patients). Reintervention failed only in one case (type IV restenosis). Clinical and angiographic follow-up data were obtained from all patients at least 9 months after treatment of in-SES restenosis and will be presented at Scientific Sessions. Conclusions: Restenosis after SES occurs more commonly in a focal pattern and in the majority of the cases involves the body or the proximal edge of the stent. We report data on the outcome of a treatment strategy adjusted according to the type of lesion (balloon angioplasty for focal body SES restenosis, restenting for all other patterns). TCT-483 Focal Sirolimus-Eluting Stent Restenosis: An Emerging Problem Gloria Melzi1, John Cosgrave2, Giuseppe Biondi-Zoccai1, Alaide Chieffo1, Flavio Airoldi1, Ioannis Iakovou2, Giuseppe M. Sangiorgi2, Iassen Michev1, Matteo Montorfano1, Antonio Colombo3 1 San Raffaele Hospital, Milano, Italy2Emo Centro Cuore Columbus, Milano, Italy3San Raffaele Hospital and Emo Centro Cuore Columbus, Milano, Italy Background: While sirolimus-eluting stent (SES) restenosis is uncommon, the optimum management remains to be defined. We assessed the hypothesis that POBA and repeat drug-eluting stent (DES) implantation would have similar outcomes in the treatment of focal SES restenosis. Methods: Our study population comprised all consecutive patients who underwent reintervention for focal (defined as <10 mm) SES restenosis between November 2002 and July 2004. Results: Seventy-five patients (89 lesions) were included: 35 (39.3%) lesions were treated with POBA and 54 (60.7%) with DES implantation. No patients were lost to clinical follow-up. Forty-three (57.3%) patients underwent angiographic follow-up and the rate of angiographic followup was the same in both groups. At follow-up (mean 14.5±6.7 months) there were no cases of myocardial infarction and 2 (2.5%) cardiac deaths, both in the POBA treatment group. Target vessel revascularization (TVR) occurred in 15 (16.9%) lesions and target lesion revascularization (TLR) in 13 (14.6%) lesions. When the outcome was analysed according to the treatment of the restenotic lesion, TLR occurred in 6 (17.1%) lesions in the POBA group and 7 (13%) in the DES group (p 0.76). Conclusions: Overall the treatment of focal SES restenosis is associated with favourable early and mid-term results in this challenging cohort of patients. These preliminary data demonstrate no clear advantages for any of modalities analysed. Thus POBA is likely the most cost-effective treatment of focal SES-restenosis. TCT-484 A New and Simple Risk Score to Predict Target Vessel Revascularization After Coronary Stenting Alexandre S Quadros, Carlos A M Gottschall, Rogério Sarmento-Leite Institute of Cardiology of Rio Grande do Sul / FUC, Porto Alegre, RS, Brazil Background: The TIMI risk score has gained wide clinical acceptance not only because of its discriminatory ability to stratify high and low risk patients with unstable angina, but also because it is a simple and easy to use clinical tool. However, reported models of a new target vessel revascularization (TVR) after coronary stenting are complicated and have not been incorporated in daily practice. Objective: We sought to develop a simple predictive score for the possibility of a new TVR after coronary stenting based on preprocedural variables. Methods: Clinical and angiographic characteristics of a prospective cohort of 848 consecutive patients (pts) submitted to 895 bare metal stent implantations were included in a dedicated database. Excluded from the study were those with unsuccessful procedures or residual stenosis>30%.
The American Journal of Cardiology© OCTOBER 16-21, 2005 TCT ABSTRACTS/Poster
WEDNESDAY 10/18/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) Independent predictors of 1-year TVR were identified by multivariate analysis, and the Hosmer-Lemeshow goodness-of-fit test was used to choose the model which most appropriately fit the data. The score points were assigned according to the relative risk ratio of 1-year TVR. Results: The mean age of our sample was 60±10.8 years, and 28.4% were women. Diabetes mellitus was present in 23 % of the pts, and 76% had an acute coronary syndrome. The mean reference vessel diameter was 3.3±0.4 mm, and the mean lesion length was 10.14±10.7 mm. The 1-year TVR rate in the 848 pts was 7.4%. By multivariate analysis, the reference vessel diameter, the lesion length and the presence of diabetes mellitus were retained in the final model (Hosmer-Lemeshow goodness-of-fit test=2.339; p=0.969). The increase of 1-year TVR rates was almost linear with each score level (0 = 1.4%, 1 = 4.5%, 2 = 7.1%, 3 = 10,4% and 4/5 = 15.7%; r =0.90; p < 0.001). The c-statistic was 0.64, similar to the TIMI risk score. Conclusions: The score herein described stratifies patients with high and low risk for a new TVR after bare metal stent implantation. It can be used as a simple clinical tool for the prediction of a new revascularization procedure in daily practice. TCT-485 Incidence and Predictors of Restenosis after Drug-Eluting Stents Placement in Real-World Patients Cheol Whan Lee, Duk-Woo Park, Bong-Ki Lee, Young-Hak Kim, MyeongKi Hong, Jae-Joong Kim, Seong-Wook Park, Seung-Jung Park Asan Medical Center, Seoul, Republic of Korea Background: Drug-eluting stents (DES) has been increasingly used in a wide variety of clinical and anatomic situations. However, data are limited regarding the predictors of DES failure in unselected lesions. Methods: We investigated the incidences and predictors of restenosis after DES implantation in routine clinical practice. A total of 1,795 consecutive patients underwent successful implantation of sirolimus-eluting (1,374 patients, 1,788 lesions) or paclitaxel-eluting (421 patients, 517 lesions) stents between Feb 2003 and Nov 2004. Of the 1,743 ligible patients (2,221 lesions), follow-up angiography at 6 months was obtained at 70.5% (1,228 patients, 1.577 lesions).All data were prospectively recorded and analyzed for the ability to predict the occurrence of restenosis defined as a diameter stenosis ≥50%. Results: Restenosis was documented in 125 patients with 138 lesions (8.8%) and target lesion revascularization was required in 70 patients with 82 lesions (5.2%). The pattern of restenosis was 85 focal (62%), 29 diffuse (21%), 11 diffuse proliferative (8%) and 13 total (9%). Lesion length, stent length, final minimal lumen diameter, preintervention minimal lumen diameter, reference artery size, complex lesions, and use of paclitaxel-eluting stent were univariate predictors of restenosis. In multivariate analysis, however, use of paclitaxel-eluting stent (OR 4.37, 95%CI 2.90-6.58, p<0.001), post-intervention final minimal lumen diameter (OR 0.32, 95%CI 0.20-0.50, p<0.001) and lesion length (OR 1.02, 95%CI 1.01-1.04, p<0.001) were independent predictors of restenosis. Conclusions: Restenosis after DES implantation in “real-world” patients was similar to the rate reported in clinical trials, confirming the efficacy of using the DES in routine clinical practice.
but not in the proximal segment. Whether distal coronary vasomotor functions might be affected by proximal DES implant has not been determined. In this study, we investigated in-stent NI, as well as vasomotor function distal sites of bare metal (BM), polyurethanecoated (PLU) and DES (Cypher) stent implant after one month. BM, PLU and Cypher stents were implanted in pig coronary arteries (stent: artery = 1.15:1) and the hearts were harvested at 4 weeks. Stented segments of vessels were analyzed by histomorphometry; arterial segments <2 cm distal to the stents were studied in an organ-chamber apparatus (BM=7, PLU=5 & Cypher=6). Endothelium-dependent (EDR) and -independent relaxation (EIDR) and contraction responses to classical agonists were investigated. NI thickness of Cypher was significantly less than BM & PLU (0.18±0.04 vs. 0.31±0.06 & 0.62±0.3mm; P<0.05). The in-stent luminal area for Cypher was higher (4.87±0.27 vs. 3.37±0.25 & 2.31±0.41mm2; P<0.05). NI area was also smaller in Cypher than in PLU (P<0.05). In the presence of L-NAME, the ratio of contractions elicited by endothelin-1/ KCl of distal to the stents segments was greater for Cypher than for BM & PLU (1.67±0.15 vs. 1.15±0.03 and 1.17±0.07%; P<0.05). The maximal dose of EDR to substance P in Cypher was less than BM & PLU (46.4±5.9 vs. 77.5±2.2 & 77.9±3.1%; P<0.05). The maximal EDR to Ca++ ionophore A23187 for Cypher was decreased (64.9±8.5 vs. 86.4±5.3 in BM & 81.8±3.9% in PLU; P=0.068). The maximal dose of EIDR to sodium nitroprusside for Cypher was higher than BM & PLU (100±4.7 vs. 69.4±7.1 & 77.1±4.6%; P<0.05). Cypher stent profoundly inhibits in-stent NI at one month post-implant in pig coronary arteries compared to bare metal. Alterations in the vasomotor function of the distal conduit artery were observed in parallel to this effect, including augmented contractile and EIDR, as well as decreased EDRs responses. These observations suggest that distal vascular spasm may be induced by elution of rapamycin from DES at 4 weeks and contribute to pathophysiological events such as abrupt closure. TCT-487 IVUS Guidance Stenting in Long De Novo Coronary Lesions is Not Associated with Improved Clinical Outcomes in Drug-Eluting Stent Era Chul-Min Ahn, Young-Guk Ko, Jaemin Shim, Jeong Geun Moon, Jin-Bae Kim, Tae-Soo Kang, Jong-Youn Kim, Sungha Park, Donghoon Choi, Yangsoo Jang, Won-Heum Shim, Seung-Yun Cho Cardiology Division, Yonsei Cardiovascular Center, Yonsei University College of Medicine, Seoul, Republic of Korea Background: The purpose of this study was to evaluate efficacy and clinical outcomes of intravascular ultrasound (IVUS)-guided stenting for the treatment of long coronary lesions in drug eluting stent (DES) era. Methods: Since January/03 to September/04, 64 long lesions (>25mm) in 58 patients treated with IVUS-guided DES implantation and 208 long lesions (>25mm) in 200 patients treated with angiography-guided DES implantation were enrolled. Primary end points were death, myocardial infarction, or ischemia-driven target vessel revascularization within 9 months of index stent procedure. Results: The baseline characteristics and clinical outcomes between 2 groups were similar. (Table)
TCT-486 Inhibition of Neointima Formation is Associated with Aberrant Endothelium-Dependent Relaxation Distal to Site of DES (Cypher) Implant in Pig Coronary Arteries Jinsheng Li, Yoritaka Otsuka, Stephen P. Mulkey, Keith A Robinson, Nicolas A F Chronos American Cardiovascular Research Institute, Norcross, GA Drug-eluting stents (DESs) have been shown to reduce neointima formation (NI) in the distal coronary segment downstream to the stent
The American Journal of Cardiology© OCTOBER 16-21, 2005 TCT ABSTRACTS/Poster
189H
P O S T E R A B S T R A C T S
WEDNESDAY 10/18/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) IVUS-guided (n=64) Age yrs 63.2 ± 9.3 Male.(%) 44 (69%) DM (%) 20 (31%) Hypertension (%) 36 (56%) Renal failure (%) 4 (6%) Hypercholesterolemia(%) 19 (30% ) Non-MI/MI(%). 51/13 ( 80%/ 20%) 60/30 ( 67%/ 33%) Cypher/Taxus stent (%) Overlapping stents (%) 25 (39%) Lesion Length (%) 35.2 ± 9.85 PreRD/PostRD (%) 2.90 ± 0.47/ 2.98 ± 0.45 PreMLD/PostMLD (%) 0.57 ± 0.39/ 2.62 ± 0.48 Acute gain (%) 2.05 ± 0.61 FU RD/MLD(%) 2.81 ± 0.35/ 2.37 ± 0.63 Late loss - 9 months (%) 0.32 ± 0.65 (n=29/64) In-stent restenosis (%) 4 (13%) (n=29/64) 30 days MACE (%) 0 (0%) 9 months MACE (%) 4 (6.3%) Death (%) 0 (0%) MI (%) 0 (0%) TVR (%) 4 (6.3%)
PAngio-guided(n=208) value 61.43 ± 10.2 NS 148 (71%) NS 85 (40%) NS 131 (62%) NS 28 (13%) NS 53 (25%) NS 156/53 ( 75% /25%) NS 258/64 ( 80%/ 20%) NS 94 (45%) NS 35.9 ± 12.99 NS 2.85 ± 0.44/ 2.91 ± 0.45 NS 0.56 ± 0.46/ 2.58 ± 0.49 NS 2.01 ± 0.62 NS 2.85 ± 0.44/ 2.35 ± 0.57 NS 0.26 ± 0.65 (n=114/208) NS 11 (9%) (n=114/208) NS 1 (0.5%) NS 13 (6.2%) NS 2 (0.9%) NS 1 (0.5%) NS 10 (4.8%) NS
Conclusions: Clinical outcomes of IVUS-guided stenting for the treatment of long de novo coronary lesions in DES era is not superior to those of angiography-guided stenting. These data suggest that the routine performance of IVUS during long lesion intervention in DES era does not improve angiographic and clinical outcome at 9 months. TCT-488 Histopathologic Features of Restenotic Lesions within Drug- Eluting Stents in Humans Alaide Chieffo1, Chiara Foglieni1, Laura Rota Nodari1, Carlo Briguori2, Gloria Melzi1, Matteo Montorfano1, Giuseppe Sangiorgi1, Alessio Giazzon1, Anton E Becker1, Antonio Colombo1, Attilio Maseri1 1 San Raffaele Scientific Institute, Milan, Italy2Clinica Mediterranea, Naples, Italy
P O S T E R A B S T R A C T S
Drug-eluting stents (DES) are associated with a lower rate of in-stent restenosis (ISR). Features about neo-intimal tissue involved in restenosis after either sirolimus- (SES) or paclitaxel-eluting stent (PES) implantation are still scanty. Methods From October 2004 to May 2005 8 pts previously treated with DES (4 PES, 4 SES) underwent directional atherectomy for ISR after 4 to 13 months. Morphology was evaluated on sections from 5 pts by Movat’s stain. Confocal microscopy was performed in all 8 pts, assessing the proliferation rate by Ki67 and inflammatory cells (lymphocytes, granulocytes, macrophages) by CD3 and CD18. Smooth muscle cells (SMC) were characterized by alpha-SM actin (SMA), Factin, myosin heavy chain type 1 - 2 (Mhc) and Collagen type I (Coll). Endothelial cells were assessed by VE-cadherin, CD34 and CD31. Results A focal restenosis was found by angiography in 7 out of 8 DES ISR. In all pts histology showed that restenotic lesions were mainly composed of intimal-media tissue, with polymer residues and fibro-lipidic areas. Confocal microscopy confirmed histology, showing prevalence of SMCs with a synthetic phenotype, absence of both inflammatory cells and endothelial lining. On serial sections sparse Ki67 positive cells were identified as SMCs. SMCs expressed SMA and F-actin in all restenotic lesions. Distinctive features between SES and PES were: 1) mean proliferation index: 0,85 % in SES, 0,41% in PES; 2) a lower expression of Mhc and Coll in SES than in PES; 3) several Mhc negative areas were observed in all PES, but not in SES; 4) no endothelial cells were detected in PES, whereas small clusters of CD 31/VE-cadherin or CD31/CD34 double positive cells were present in SES tissues, far from the polymer. Conclusions: Intra-DES restenotic tissue is mainly composed by SMCs of a synthetic phenotype, still proliferating up to 13-months follow-up. Cell phenotype differences between PES and SES, proliferation features and incomplete endothelialization are under investigation. These preliminary results suggest different mechanisms of restenosis in the two DES types. These findings may have relevant implications for the optimal duration of anti-platelets pts therapy for different types of DES.
190H
TCT-489 Long-term Outcomes of Repeat Revascularization for Treatment of Drug-Eluting Stent Restenosis Bong-Ki Lee, Seong-Wook Park, Duk-Woo Park, Kyoung-Ha Park, MiJeong Kim, Bong-Ryong Choi, Il-Woo Suh, Young-Hak Kim, Cheol Whan Lee, Myeong-Ki Hong, Jae-Joong Kim, Seung-Jung Park Asan Medical Center, Seoul, Republic of Korea Background: Outcomes of various treatment approaches for restenosis of drug-eluting stent (DES) are not well known. Methods: This study included 1,835 patients with 2,352 lesions who underwent percutaneous coronary interventions using sirolimus-eluting stents (SES, 1,856 lesions) or paclitaxel-eluting stents (PES, 488 lesions) from February 2003 to September 2004. Results: Restenosis in analysis segment was documented in 68 lesions (5.5%) of the SES group and 63 lesions (19.9%) of the PES group (p<0.001). In lesions with restenosis, 70% of the SES group and 50% of the PES group were found as a focal restenotic pattern (p=0.02). Target lesion revascularization (TLR) was performed in 23 patients (1.6%) with 24 lesions of the SES group and 27 patients (6.9%) with 35 lesions of the PES group (p<0.001). For treatment of restenosis, cutting balloon angioplasty for focal restenosis was performed in 6 lesions (10.2 %). SES implantation was used in 11 (45.8 %) and 16 (45.7 %) restenoses in the SES and PES groups, respectively. PES implantation was performed in 1 (4.2 %) restenosis of the SES group. Intracoronary brachytherapy was used in 6 (25.0 %) and 7 (20.0 %) diffuse restenoses in the SES and PES group, respectively. Bypass surgery was performed in 3 (12.5%) SES and 6 (17.1%) PES patients. During follow-up period (median, 11.5 months), death, myocardial infarction or stent thrombosis did not occur in patients with TLR. Recurrent restenosis was documented in 4 (12.5%) lesions (1 after cutting balloon angioplasty and 3 after brachytherapy) from 32 eligible lesions. Repeat TLR was performed in 2 recurrent restenoses including SES implantation for one patient after cutting balloon angioplasty and bypass surgery for one patient after coronary brachytherapy. Conclusion: Repeat revascularization with DES appears to be a safe and effective treatment approach for treatment of drug-eluting stent restenosis. TCT-490 Multibiomarker Measurement for the Prediction of One-Year FollowUp after Elective PCI; A New Benchmark for Clinical Outcome? Saskia Z H Rittersma1, Pascalle S Monraats2, J Wouter Jukema2, Aeilko H Zwinderman1, Moniek P M de Maat3, Pieter A F Doevendans4, Rene A Tio5, Arnoud van der Laarse2, Jan G P Tijssen1, Jan P van Straalen1, Johan Fischer1, Robbert J de Winter1 1 Academic Medical Center, Amsterdam, The Netherlands2Leiden University Medical Center, Leiden, The Netherlands3Erasmus Medical Center, Rotterdam, The Netherlands4University Medical Center, Utrecht, The Netherlands5University Medical Center, Groningen, The Netherlands Background: Baseline biomarker levels may be useful in risk stratification for target vessel revascularization (TVR) and for the prediction of long-term clinical outcome. However, little is known about the use of a multibiomarker strategy in patients treated non-urgently with PCI. Methods: The GENDER project, a multicenter prospective study, included consecutive patients after successful PCI and was designed to study the predictive value of various risk factors for clinical restenosis (TVR) or the combined endpoint of death, myocardial infarction andTVR (MACE). Baseline plasma samples were available in 1325 patients, in whom off-line analysis of CRP, NT-proBNP, Creatinine and cardiac Troponin t (cTnT) was performed. Results: Median follow-up duration was 11 months (IQR 8.9-13.5). During follow-up, TVR occurred in 155 patients (11.7%), MI in 20 (1.5%), cardiac death in 17 (1.3%), noncardiac death in 8 (0.6%);
The American Journal of Cardiology© OCTOBER 16-21, 2005 TCT ABSTRACTS/Poster
WEDNESDAY 10/18/05 9:00 AM - 5:00 PM (Exhibit Halls A and B) MACE occurred in 184 patients (13.9%). Elevated biomarkers were not associated with TVR, but individual biomarkers were predictive for allcause mortality. Multivariate stepwise Cox regression analysis showed that age >65 years (Hazard ratio [HR] 3.2, 95% CI 1.1-8.9) and elevated NT-proBNP (HR 4.4, 95% CI 1.7-11.0) were independent predictors for mortality. There was no relationship between the number of elevated biomarkers and TVR, MI or MACE. However, the number of elevated biomarkers corresponded positively to the risk of death (P = 0.001). Comparison between the 2 participating centers showed no differences in mortality in each group stratified to the number of elevated biomarkers. Conclusions: Elevated NT-proBNP is a strong independent risk factor for 1-year mortality after non-urgent PCI. A multibiomarker strategy with CRP, NT-proBNP, Creatinine and cTnT provides additional prognostic information for the risk of death after PCI and may be useful in daily practice as a benchmark for the comparison of PCI centers.
P O S T E R A B S T R A C T S
The American Journal of Cardiology© OCTOBER 16-21, 2005 TCT ABSTRACTS/Poster
191H