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Trials  2009 

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

DOI: 10.1186/1745-6215-10-98

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Abstract:

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.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.ClinicalTrials.gov number, NCT00699543.Previous randomized trials have shown the efficacy of a slow-release polymeric sirolimus-eluting stent (Cypher?, Cordis, Warren, NJ, USA), paclitaxel-eluting stent (Taxus?, Boston Scientific, Natick, MA, USA), and zotarolimus-eluting stent (Endeavor?, Medtronic, Minneapolis, MN, USA) over bare metal stents in reducing neointimal hyperplasia, late luminal loss, and angiographic restenosis leading to decreased target lesion revascularization [1-11] The Paclitaxel-eluting 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[12]In the PECOPS I, which was one-arm observational study, the results of Coroflex Please? stent were within the range of other Paclitaxel-eluting coronary stents [12,13] Compared with binary restenosis rate of 7.9% in Taxus IV trial, Coroflex? Please stent showed 7.8% of restenosis rate[7] The 3.1% of 30 day MACE rate is within the range of other trials with stents eluting Paclitaxel or Sirolimus. The 6 month MACE rates in PECOPS I were 8.0%, which was similar to 7.8%, and 8.5% in Taxus II MR and SR, respectively[6] In Taxus IV, 9 month f

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