TY - JOUR
T1 - Novel paclitaxel-eluting, biodegradable polymer coated stent in the treatment of de novo coronary lesions
T2 - A prospective multicenter registry
AU - Buszman, Paweł
AU - Trznadel, Stanisław
AU - Milewski, Krzysztof
AU - Rzeźniczak, Janusz
AU - Przewłocki, Tadeusz
AU - Kośmider, Maciej
AU - Wójcik, Jaroslaw
AU - Janczak, Jacek
AU - Zurakowski, Aleksander
AU - Kondys, Marek
AU - Król, Marek
AU - Kinasz, Leszek
AU - Jaklik, Andrzej
AU - Rzeszutko, Łukasz
AU - Kałuza, Grzegorz L.
AU - Kiesz, Stephan
AU - Gil, Robert
N1 - Copyright:
Copyright 2008 Elsevier B.V., All rights reserved.
PY - 2008/1/1
Y1 - 2008/1/1
N2 - 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.
AB - 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.
KW - Percutaneous coronary intervention
KW - Quantitative coronary angiography
KW - Restenosis
KW - Thrombosis
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U2 - 10.1002/ccd.21392
DO - 10.1002/ccd.21392
M3 - Article
C2 - 18098182
AN - SCOPUS:38549103648
VL - 71
SP - 51
EP - 57
JO - Catheterization and Cardiovascular Interventions
JF - Catheterization and Cardiovascular Interventions
SN - 1522-1946
IS - 1
ER -