Published in:
Open Access
01-12-2009 | Study protocol
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 Seo, Hui-Kyung Jeon, Kyung-Woo Park, Jong-Seon Park, Jang-Ho Bae, Sang-Wook Kim, Keon-Woong Moon, Jae-Woong Choi, Sang-Gon Lee, Woo-Young Chung, Tae-Jin Youn, Soo-Joong Kim, Doo-Il Kim, Byung-Ok Kim, Min-Su Hyon, Keum-Soo Park, Tae-Joon Cha, Hweung-Kon Hwang, Seung-Ho Hur, Hyo-Soo Kim
Published in:
Trials
|
Issue 1/2009
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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.