Novel paclitaxel‐eluting, biodegradable polymer coated stent in the treatment of de novo coronary lesions: A prospective multicenter registry

作者：Paweł Eugeniusz Buszman, Stanisław Trznadel, Krzysztof P. Milewski, Janusz Rzeźniczak, Tadeusz Przewłocki, Maciej Kośmider, Jarosław Wójcik, Jacek Jańczak, Aleksander Żurakowski, Marek Kondys, Marek Król, Leszek Kinasz, Andrzej Jaklik, Łukasz Rzeszutko, Grzegorz L. Kałuża, Stephan Kiesz, Robert Julian Gil · 发表于：Catheterization and Cardiovascular Interventions · 年份：2007 · DOI：10.1002/ccd.21392 · 被引用次数：33 · 研究领域：Coronary Interventions and Diagnostics、Cerebrovascular and Carotid Artery Diseases、Cardiac and Coronary Surgery Techniques

OBJECTIVES: The purpose of the present study was to evaluate the efficacy and safety of a biodegradable polymer coated, paclitaxel eluting stent (Luc-Chopin(2)) based on 9-months angiographic and 12-months clinical follow-up results. BACKGROUND: First-generation drug-eluting stents utilize nonbioabsorbable polymeric coatings, whose persistent presence in the arterial wall may negatively affect long-term outcomes. Bioabsorbable coatings with a degradation period matched to that of the drug elution may be a better alternative, clinically and economically. METHODS: We conducted a prospective, multicenter first-in-man registry of a novel, locally developed, bioabsorbable-coated, paclitaxel-eluting coronary stent in 116 patients with single-lesion de novo coronary disease. RESULTS: Major adverse cardiac events occurred in 7.8% patients within 12 months. There were no late thrombotic events, death, stroke, or surgical revascularization in that period. There were two myocardial infarctions, one related to recent subacute stent thrombosis and another associated with restenosis. By 12 months, target vessel revascularization was performed in 7.8%; 2.9% were ischemia-driven and the rest were mandated at 9 months in accordance with a control angiography protocol. Core-lab assessed binary in-stent restenosis (> or =50% DS) was noted in 11.9% patients and mean late loss was 0.46 +/- 0.47 mm. CONCLUSIONS: This first-in-man experience obtained in a multicenter registry of real-world de novo ...