The paclitaxel‐eluting coroflex™ please stent study (PECOPS I): The 3‐year clinical follow‐up |
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Authors: | Martin Unverdorben MD PhD Ralf Degenhardt PhD Marcus Wiemer MD Dieter Horstkotte MD Henrik Schneider MD Christoph Nienaber MD Wolfgang Bocksch MD Michael Gross MD Michael Boxberger PhD Christian Vallbracht MD |
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Affiliation: | 1. Clinical Research Institute, Center for Cardiovascular Diseases, Rotenburg an der Fulda, Germany;2. Email:r.degenhardt@ hkz‐rotenburg.de;5. Heart and Diabetes Center NRW, Cardiologic Clinic, Bad Oeynhausen, Germany;6. Clinic for Internal Medicine, Department of Cardiology, University of Rostock, Rostock, Germany;7. Medizinische Klinik, Kardiologie, Charité‐Hochschulmedizin Berlin, Berlin, Germany;8. B.Braun Melsungen AG, Division Vascular, Systems, Berlin, Germany;9. Cardiologic Clinic, Center for Cardiovascular Diseases, Rotenburg an der Fulda, Germany |
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Abstract: | Background : The evaluation of drug‐eluting devices in humans should include longterm follow‐up owing to risk of late target vessel thrombosis with the possible fatal sequel. Methods and Results : Therefore, the three‐year clinical outcome of the paclitaxeleluting Corofiex® Please stent in patients with de‐novo coronary lesions was evaluated in the single‐arm PECOPS I pilot study. The clinical data of 123/125 (98.4%) of all patients included were available 3.05 ± 0.12 years following stent deployment. In the intention‐to‐treat analysis the incidence of cardiac death was 9/123 (7.3%), of myocardial infarction 4/123 (3.3%), and of in‐segment target lesion revascularization 14/123 (11.4%). Target lesion revascularizations tended (p = 0.30) to occur less frequently (9/96 (16.6%)) in those patients in whom the stent length was longer than the lesion (4.80 ± 2.71 mm) compared to 5/27 (18.5%) in those patients in whom the stent was shorter than the lesion (?3.0 ± 2.43 mm). Stent thromboses occurred in 2/123 (1.6%) patients during the first 6 months, one of which two days after premature discontinuation of clopidogrel. The total 3‐year MACE rate was 22/123 (17.9%). Conclusion : The present study describes the paclitaxel‐eluting Corotlex Please stent as a safe device with good long term performance when deployed in native coronary arteries. The occurrence of late major adverse events and late thromboses in particular seem to be very low. © 2009 Wiley‐Liss, Inc. |
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Keywords: | restenosis paclitaxel drug‐eluting stents PECOPS I 3‐year follow‐up |
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