The Paclitaxel‐Eluting Coroflex™ Stent Study II (PECOPS II) Acute and 6‐Month Clinical and Angiographic Follow‐Up, 1‐Year Clinical Follow‐Up |
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| Authors: | MARCUS WIEMER MD RALF DEGENHARDT PhD CHRISTIAN VALLBRACHT MD DIETER HORSTKOTTE MD HENRIK SCHNEIDER MD CHRISTOPH NIENABER MD WOLFGANG BOCKSCH MD MICHAEL BOXBERGER MD PhD MARTIN UNVERDORBEN MD PhD for the PECOPS II Investigators |
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| Institution: | 1. Department of Cardiology, Heart and Diabetes Center North Rhine‐Westphalia, Ruhr University Bochum, Bad Oeynhausen, Germany;2. Clinical Research Institute, Center for Cardiovascular Diseases, Rotenburg an der Fulda, Germany;3. Cardiologic Clinic, Center for Cardiovascular Diseases, Rotenburg an der Fulda, Germany;4. University of Rostock, Clinic for Internal Medicine, Department of Cardiology, Rostock, Germany;5. Medizinische Klinik, Kardiologie, Charité ‐ Hochschulmedizin Berlin, Berlin, Germany;6. B.Braun Melsungen AG, Division Vascular, Systems, Berlin, Germany |
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| Abstract: | Background and Objectives: Paclitaxel‐coated stents have proven their efficacy for reducing restenosis in de novo coronary artery lesions and in‐stent restenoses with superiority compared to bare metal stents. This study was performed to evaluate the procedural and 1 year results of the Paclitaxel‐eluting Coroflex? Please stent in coronary artery lesions. Methods: One‐hundred and twenty‐nine patients (66.2 ± 8.2 years, 31.0% diabetics, 20.2% unstable angina, 41.8% multivessel disease) were enrolled per protocol for elective single stent deployment into native de novo or post‐PTCA restenotic coronary lesions.The mean reference diameter was 2.84 ± 0.43 mm, the lesion length 12.51 ± 4.6 mm, and the minimal lumen diameter 0.75 ± 0.29 mm. Follow‐up was performed clinically in 129/129 (100%) after 6 and 12 months and angiographically in 120/129 (93%) patients after 6 months. Results: The success rates of the procedure and deployment were 100% and 95.3%, respectively. The in‐stent late loss and the late‐loss index were 0.27 ± 0.59 mm and 0.17 ± 0.40 resulting in binary in‐stent restenoses in 16/120 (13.3%) subjects and in‐segment restenoses in 20/120 (16.7%) subjects. Major adverse cardiac events occurred in 23/129 (17.8%) during the first 6 months of follow‐up with 3/129 (2.3%) myocardial infarctions, 1/129 (0.8%) secondary to stent thrombosis. From 6 to 12 months, 2/129 (1.6%) nonlesion related PCI were performed. Conclusion: The data of the Paclitaxel‐eluting Coroflex? Please stent evaluated in PECOPS II are within the range of the other currently available Paclitaxel‐eluting stent. (J Interven Cardiol 2010;23:160‐166) |
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