Novel paclitaxel-eluting, biodegradable polymer coated stent in the treatment of de novo coronary lesions: A prospective multicenter registry
Autor: | Tadeusz Przewłocki, Leszek Kinasz, Maciej Kośmider, Marek Kondys, Jacek Janczak, Grzegorz L. Kaluza, Paweł Buszman, Jarosław Wójcik, Janusz Rzeźniczak, Stanislaw Trznadel, Robert J. Gil, Aleksander Zurakowski, Jaklik A, Stephan Kiesz, Marek Król, Łukasz Rzeszutko, Krzysztof Milewski |
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Rok vydání: | 2007 |
Předmět: |
Male
medicine.medical_specialty Paclitaxel medicine.medical_treatment Coronary Disease Comorbidity Coronary Angiography Coronary Restenosis chemistry.chemical_compound Coated Materials Biocompatible Restenosis Coronary stent medicine Humans Radiology Nuclear Medicine and imaging Prospective Studies Registries Prospective cohort study Stroke Aged business.industry Coronary Stenosis Stent Percutaneous coronary intervention Drug-Eluting Stents General Medicine Middle Aged medicine.disease Thrombosis Surgery chemistry Female Radiology Cardiology and Cardiovascular Medicine business |
Zdroj: | Catheterization and Cardiovascular Interventions. 71:51-57 |
ISSN: | 1522-726X 1522-1946 |
Popis: | Objectives: The purpose of the present study was to evaluate the efficacy and safety of a biodegradable polymer coated, paclitaxel eluting stent (Luc-Chopin2) 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 (≥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 lesions (almost half of lesions were class B2 or C by AHA classification) showed a favorable safety profile and acceptable efficacy through 12 months. Randomized comparison with a benchmark nonbioabsorbable polymer coated paclitaxel eluting stent should be undertaken to validate this initial positive experience. © 2008 Wiley-Liss, Inc. |
Databáze: | OpenAIRE |
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