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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

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Author(s): Seo Jae-Bin | Jeon Hui-Kyung | Park Kyung-Woo | Park Jong-Seon | Bae Jang-Ho | Kim Sang-Wook | Moon Keon-Woong | Choi Jae-Woong | Lee Sang-Gon | Chung Woo-Young | Youn Tae-Jin | Kim Soo-Joong | Kim Doo-Il | Kim Byung-Ok | Hyon Min-Su | Park Keum-Soo | Cha Tae-Joon | Hwang Hweung-Kon | Hur Seung-Ho | Kim Hyo-Soo

Journal: Trials
ISSN 1745-6215

Volume: 10;
Issue: 1;
Start page: 98;
Date: 2009;
Original page

ABSTRACT
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.
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Tango Rapperswil
Tango Rapperswil