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

Paweł Buszman, Stanisław Trznadel, Krzysztof Milewski, Janusz Rzeźniczak, Tadeusz Przewłocki, Maciej Kośmider, Jaroslaw Wójcik, Jacek Janczak, Aleksander Zurakowski, Marek Kondys, Marek Król, Leszek Kinasz, Andrzej Jaklik, Łukasz Rzeszutko, Grzegorz L. Kałuza, Stephan Kiesz, Robert Gil

Research output: Contribution to journalArticlepeer-review

40 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)51-57
Number of pages7
JournalCatheterization and Cardiovascular Interventions
Volume71
Issue number1
DOIs
StatePublished - Jan 1 2008

Keywords

  • Percutaneous coronary intervention
  • Quantitative coronary angiography
  • Restenosis
  • Thrombosis

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

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