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

摘要

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.