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

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

doi:10.1186/1745-6215-10-98

Abstract

BackgroundPrevious 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.MethodsIn 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.DiscussionThe 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 registrationClinicalTrials.gov number, NCT00699543.

Highlights

Previous randomized trials have showed the superiority of Paclitaxel-eluting stent over bare metal stent in angiographic and clinical outcomes
In the PECOPS I, which was one-arm observational study, the results of Coroflex PleaseTM 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, CoroflexTM Please stent showed 7.8% of restenosis rate[7] The 3.1% of 30 day Major Cardiac Adverse Events (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 follow up revealed a MACE rate of 8.5%[7] In Taxus ATLAS trial, Taxus LiberteTM stent was proved to be non-inferior to TAXUS ExpressTM with 9 month Target Vessel Revascularization (TVR) 8.0%[14] (Table 1) In other words, the efficacy of Coroflex Please stent has not been evaluated in wide range of lesion complexity met in the real world and not been compared with the similar taxol-eluting stents like Taxus stent

Summary

Introduction

Previous randomized trials have showed the superiority of Paclitaxel-eluting stent over bare metal stent in angiographic and clinical outcomes. Previous randomized trials have shown the efficacy of a slow-release polymeric sirolimus-eluting stent (CypherTM, Cordis, Warren, NJ, USA), paclitaxel-eluting stent (TaxusTM, Boston Scientific, Natick, MA, USA), and zotarolimus-eluting stent (EndeavorTM, Medtronic, Minneapolis, MN, USA) over bare metal stents in reducing neointimal hyperplasia, late luminal loss, and angiographic restenosis leading to decreased target lesion revascularization [1,2,3,4,5,6,7,8,9,10,11] The Paclitaxel-eluting Coroflex PleaseTM stent is a newly developed drug eluting stent using the Coroflex® stent platform combined with the drug paclitaxel contained in a polymer coating[12]. 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 follow up revealed a MACE rate of 8.5%[7] In Taxus ATLAS trial, Taxus LiberteTM stent was proved to be non-inferior to TAXUS ExpressTM with 9 month TVR 8.0%[14] (Table 1) In other words, the efficacy of Coroflex Please stent has not been evaluated in wide range of lesion complexity met in the real world and not been compared with the similar taxol-eluting stents like Taxus stent.

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