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

Authors
Jae-Bin SeoHui-Kyung JeonKyung-Woo ParkJong-Seon ParkJang-Ho BaeSang-Wook KimKeon-Woong MoonJae-Woong ChoiSang-Gon LeeWoo-Young ChungTae-Jin YounSoo-Joong KimDoo-Il KimByung-Ok KimMin-Su HyonKeum-Soo ParkTae-Joon ChaHweung-Kon HwangSeung-Ho HurHyo-Soo Kim
Department
Dept. of Internal Medicine (내과학)
Issue Date
2009
Citation
Trials, Vol.10(1) : 98-98, 2009
ISSN
1745-6215
Abstract
Background Previous randomized trials have showed the superiority of Paclitaxel-eluting stent over bare metal stent in angiographic and clinical outcomes. Coroflex Please™ stent is a newly developed drug eluting stent using the Coroflex™ 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™ stent were within the range of those of Taxus, the 1st generation paclitaxel-eluting stent (PES). However, there have been no studies directly comparing the Coroflex Please™ stent with the Taxus Liberte™ stent that is the newest version of Taxus. Therefore, prospective, randomized trial is required to demonstrate the non-inferiority of Coroflex Please™ stent compared with Taxus Liberte™ stent in a head-to-head manner. Methods In the comparison of Efficacy between COroflex PLEASe™ ANd Taxus™ stent(ECO-PLEASANT) trial, approximately 900 patients are being prospectively and randomly assigned to the either type of Coroflex Please™ stent and Taxus Liberte™ 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. Discussion The ECO-PLEASANT trial is the study not yet performed to directly compare the efficacy and safety of the Coroflex Please™ versus Taxus Liberte™ stent. On the basis of this trial, we will be able to find out whether the Coroflex Please™ stent is non-inferior to Taxus Liberte™ stent or not. Trial registration ClinicalTrials.gov number, NCT00699543
URI
http://kumel.medlib.dsmc.or.kr/handle/2015.oak/34773
Appears in Collections:
1. Journal Papers (연구논문) > 1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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