7 research outputs found
Efficacies of the new Paclitaxel-eluting Coroflex Pleaseā¢ Stent in percutaneous coronary intervention; comparison of efficacy between Coroflex Pleaseā¢ and Taxusā¢ (ECO-PLEASANT) trial: study rationale and design
<p>Abstract</p> <p>Background</p> <p>Previous randomized trials have showed the superiority of Paclitaxel-eluting stent over bare metal stent in angiographic and clinical outcomes. Coroflex Pleaseā¢ stent is a newly developed drug eluting stent using the Coroflexā¢ 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 Pleaseā¢ stent were within the range of those of Taxus, the 1<sup>st </sup>generation paclitaxel-eluting stent (PES). However, there have been no studies directly comparing the Coroflex Pleaseā¢ stent with the Taxus Liberteā¢ stent that is the newest version of Taxus. Therefore, prospective, randomized trial is required to demonstrate the non-inferiority of Coroflex Pleaseā¢ stent compared with Taxus Liberteā¢ stent in a head-to-head manner.</p> <p>Methods</p> <p>In the comparison of Efficacy between COroflex PLEASeā¢ ANd Taxusā¢ stent(ECO-PLEASANT) trial, approximately 900 patients are being prospectively and randomly assigned to the either type of Coroflex Pleaseā¢ stent and Taxus Liberteā¢ 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.</p> <p>Discussion</p> <p>The ECO-PLEASANT trial is the study not yet performed to directly compare the efficacy and safety of the Coroflex Pleaseā¢ versus Taxus Liberteā¢ stent. On the basis of this trial, we will be able to find out whether the Coroflex Pleaseā¢ stent is non-inferior to Taxus Liberteā¢ stent or not.</p> <p>Trial registration</p> <p>ClinicalTrials.gov number, NCT00699543.</p