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, 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, 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

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.

References

    1. Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnàr F, Falotico R, RAVEL Study Group, Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions A randomized comparison of a sirolimus eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002;346:1773–80. doi: 10.1056/NEJMoa012843.
    1. Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE, SIRIUS Investigators Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003;349:1315–23. doi: 10.1056/NEJMoa035071.
    1. Schofer J, Schlüter M, Gershlick AH, Wijns W, Garcia E, Schampaert E, Breithardt G, E-SIRIUS Investigator Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomized controlled trial (E-SIRIUS) Lancet. 2003;362:1093–9. doi: 10.1016/S0140-6736(03)14462-5.
    1. Schampaert E, Cohen EA, Schlüter M, Reeves F, Traboulsi M, Title LM, Kuntz RE, Popma JJ, C-SIRIUS Investigators The Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries (C-SIRIUS) J Am Coll Cardiol. 2004;43:1110–5. doi: 10.1016/j.jacc.2004.01.024.
    1. Ardissino D, Cavallini C, Bramucci E, Indolfi C, Marzocchi A, Manari A, Angeloni G, Carosio G, Bonizzoni E, Colusso S, Repetto M, Merlini PA, SES-SMART Investigators Sirolimus-eluting vs uncoated stents for prevention of restenosis in small coronary arteries: a randomized trial. JAMA. 2004;292:2727–34. doi: 10.1001/jama.292.22.2727.
    1. Colombo A, Drzewiecki J, Banning A, Grube E, Hauptmann K, Silber S, Dudek D, Fort S, Schiele F, Zmudka K, Guagliumi G, Russell ME, TAXUS II Study Group Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation. 2003;108:788–794. doi: 10.1161/01.CIR.0000086926.62288.A6.
    1. Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME, TAXUS-IV Investigators A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004;350:221–231. doi: 10.1056/NEJMoa032441.
    1. Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME, TAXUS-IV Investigators One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting TAXUS stent: the TAXUS-IV trial. Circulation. 2004;109:1942–7. doi: 10.1161/01.CIR.0000127110.49192.72.
    1. Dawkins KD, Grube E, Guagliumi G, Banning AP, Zmudka K, Colombo A, Thuesen L, Hauptman K, Marco J, Wijns W, Popma JJ, Koglin J, Russell ME. Clinical efficacy of polymer-based paclitaxel-eluting stents in the treatment of complex, long coronary artery lesions from a multicenter, randomized trial: support for the use of drug-eluting stents in contemporary clinical practice. Circulation. 2005;112:3306–3313. doi: 10.1161/CIRCULATIONAHA.105.552190.
    1. Meredith IT, Ormiston JA, Whitbourn R, Kay IP, Miller D, Bonan R, Popma JJ, Cutlip DE, Fitzgerald P, Prpic R, Kuntz RE. First-in-human study of the endeavor zotarolimus-eluting Phosphorylcholine-encapsulated stent system in de novo native coronary artery lesions: Endeavor I trial. EuroIntervention. 2005;1:157–164.
    1. Fajadet J, Wijns W, Laarman GJ, Kuck KH, Ormiston J, Münzel T, Popma JJ, Fitzgerald PJ, Bonan R, Kuntz RE, ENDEAVOR II Investigators Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for treatment of native coronary artery lesions: clinical and angiographic results of the ENDEAVOR II trial. Circulation. 2006;114:798–806. doi: 10.1161/CIRCULATIONAHA.105.591206.
    1. Unverdorben M, Degenhardt R, Vallbracht C, Wiemer M, Horstkotte D, Schneider H, Nienaber C, Bocksch W, Gross M, Boxberger M, PECOPS I Investigators The paclitaxel-eluting Coroflex Please stent pilot study (PECOPS I): acute and 6-month clinical and angiographic follow-up. Catheter Cardiovasc Interv. 2006;67:703–710. doi: 10.1002/ccd.20731.
    1. Unverdorben M, Degenhardt R, Wiemer M, Horstkotte D, Schneider H, Nienaber C, Bocksch W, Gross M, Boxberger M, Vallbracht C, for the PECOPS I Investigators The Paclitaxel-Eluting Coroflex™ Please Stent Pilot Study (PECOPS I): The one-year clinical follow-up. Clin Res Cardiol. 2007;96:803–811. doi: 10.1007/s00392-007-0560-6.
    1. Turco MA, Ormiston JA, Popma JJ, Mandinov L, O'Shaughnessy CD, Mann T, McGarry TF, Wu CJ, Chan C, Webster MW, Hall JJ, Mishkel GJ, Cannon LA, Baim DS, Koglin J. Polymer-based, paclitaxel-eluting TAXUS Liberté stent in de novo lesions: the pivotal TAXUS ATLAS trial. J Am Coll Cardiol. 2007;49:1676–83. doi: 10.1016/j.jacc.2007.01.069.
    1. Walsh V, Goodman J. From taxol to Taxol: the changing identities and ownership of an anti-cancer drug. Med Anthropol. 2002;21:307–336. doi: 10.1080/01459740214074.
    1. Halkin A, Stone GW. Polymer-based paclitaxel-eluting stents in percutaneous coronary intervention: a review of the TAXUS trials. J Interv Cardiol. 2004;17:271–282. doi: 10.1111/j.1540-8183.2004.04040.x.
    1. Rowinsky EK, Donehower RC. Paclitaxel (Taxol) N Engl J Med. 1995;332:1004–1014. doi: 10.1056/NEJM199504133321507.
    1. Axel DI, Kunert W, Göggelmann C, Oberhoff M, Herdeg C, Küttner A, Wild DH, Brehm BR, Riessen R, Köveker G, Karsch KR. Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and in vivo using local drug delivery. Circulation. 1997;96:636–645.
    1. Wiskirchen J, Schöber W, Schart N, Kehlbach R, Wersebe A, Tepe G, Claussen CD, Duda SH. The effects of paclitaxel on the three phases of restenosis: Smooth muscle cell proliferation, migration, and matrix formation: an in vitro study. Invest Radiol. 2004;39:565–571. doi: 10.1097/01.rli.0000133815.22434.55.
    1. Carter AJ, Aggarwal M, Kopia GA, Tio F, Tsao PS, Kolata R, Yeung AC, Llanos G, Dooley J, Falotico R. Long-term effects of polymer-based, slow-release, sirolimus-eluting stents in a porcine coronary model. Cardiovasc Res. 2004;63:617–24. doi: 10.1016/j.cardiores.2004.04.029.
    1. Farb A, Heller PF, Shroff S, Cheng L, Kolodgie FD, Carter AJ, Scott DS, Froehlich J, Virmani R. Pathological analysis of local delivery of paclitaxel via a polymer-coated stent. Circulation. 2001;104:473–9. doi: 10.1161/hc3001.092037.
    1. Park DW, Hong MK, Mintz GS, Lee CW, Song JM, Han KH, Kang DH, Cheong SS, Song JK, Kim JJ, Weissman NJ, Park SW, Park SJ. Two-year follow-up of the quantitative angiographic and volumetric intravascular ultrasound analysis after nonpolymeric paclitaxel-eluting stent implantation: late "catch-up" phenomenon from ASPECT Study. J Am Coll Cardiol. 2006;48:2432–9. doi: 10.1016/j.jacc.2006.08.033.

Source: PubMed

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

3
Se inscrever