Efficacies of the new Paclitaxel-eluting Coroflex Please (TM) Stent in percutaneous coronary intervention; comparison of efficacy between Coroflex Please (TM) and Taxus (TM) (ECO-PLEASANT) trial: study rationale and design

Title
Efficacies of the new Paclitaxel-eluting Coroflex Please (TM) Stent in percutaneous coronary intervention; comparison of efficacy between Coroflex Please (TM) and Taxus (TM) (ECO-PLEASANT) trial: study rationale and design
Authors
Park, K.S.
Keywords
MUSCLE-CELL PROLIFERATION, MUSCLE-CELL PROLIFERATION, ARTERY LESIONS, SLOW-RELEASE
Issue Date
2009-10
Publisher
BIOMED CENTRAL LTD
Abstract
Background: Previous randomized trials have showed the superiority of Paclitaxel-eluting stent over bare metal stent in angiographic and clinical outcomes. Coroflex Please (TM) stent is a newly developed drug eluting stent using the Coroflex (TM) stent platform combined with the drug paclitaxel contained in a polymer coating. PECOPS I trial, one-arm observational study, showed that the clinical and angiographic outcomes of Coroflex Please (TM) stent were within the range of those of Taxus, the 1(st) generation paclitaxel-eluting stent (PES). However, there have been no studies directly comparing the Coroflex Please (TM) stent with the Taxus Liberte (TM) stent that is the newest version of Taxus. Therefore, prospective, randomized trial is required to demonstrate the non-inferiority of Coroflex Please (TM) stent compared with Taxus Liberte (TM) stent in a head-to-head manner.
Methods: In the comparison of Efficacy between COroflex PLEASe (TM) ANd Taxus (TM) stent(ECO-PLEASANT) trial, approximately 900 patients are being prospectively and randomly assigned to the either type of Coroflex Please (TM) stent and Taxus Liberte (TM) stent via web-based randomization. The primary endpoint is clinically driven target vessel revascularization at 9 months. The secondary endpoints include major cardiac adverse events, target vessel failure, stent thrombosis and angiographic efficacy endpoints.
URI
http://dspace.inha.ac.kr/handle/10505/1861
ISSN
1745-6215
Appears in Collections:
Medical School/College of Medicine (의학전문대학원/의과대학) > Medical Science (의학) > Journal Papers, Reports(의학 논문, 보고서)
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