Study Design and Rationale of “A Multicenter, Open-Labeled, Randomized Controlled Trial Comparing Three 2nd-Generation Drug-Eluting Stents in Real-World Practice” (CHOICE trial) - 28/07/13

Doi : 10.1016/j.ahj.2013.04.014

Young Jin Youn, MD ^a, Jun-Won Lee, MD ^a, Sung Gyun Ahn, MD ^a, Seung-Hwan Lee, MD ^a, Hyun Hee Choi, MD ^b, Hyunmin Choi, MD ^c, Cheol Ung Choi, MD ^d, Jin Bae Lee, MD ^e, Jang Hyun Cho, MD ^f, Tae Soo Kang, MD ^g, Byung Ryul Cho, MD ^h, Kwang Soo Cha, MD ⁱ, Moo Hyun Kim, MD ^j, Min Su Hyon, MD ^k, Sang-Sig Cheong, MD ^l, Do-Sun Lim, MD ^m, Kyoo Rok Han, MD ⁿ, Myung Ho Jeong, MD ^o, Keum Soo Park, MD ^p, Junghan Yoon, MD ^a,^{^⁎}
^a Division of Cardiology, Yonsei University Wonju Christian Hospital, Wonju, South Korea
^b Division of Cardiology, Chuncheon Hallym University Hospital, Chuncheon, South Korea
^c Division of Cardiology, Inje University Ilsan-Paik Hospital, Goyang, South Korea
^d Division of Cardiology, Korea University Guro Hospital, Seoul, South Korea
^e Division of Cardiology, Daegu Catholic University Hospital, Daegu, South Korea
^f Division of Cardiology, Suncheon St. Carollo Hospital, Suncheon, South Korea
^g Division of Cardiology, Dankook University Hospital, Cheonan, South Korea
^h Division of Cardiology, Kangwon National University Hospital, Chuncheon, South Korea
ⁱ Division of Cardiology, Pusan National University Hospital, Busan, South Korea
^j Division of Cardiology, Dong-A University Hospital, Busan, South Korea
^k Division of Cardiology, Soonchunhyang University Hospital, Seoul, South Korea
^l Division of Cardiology, Ulsan University Gangneung Asan Hospital, Gangneung, South Korea
^m Division of Cardiology, Korea University College of Medicine Anam Hospital, Seoul, South Korea
ⁿ Division of Cardiology, Kangdong Sacred Heart Hospital, Seoul, South Korea
^o Division of Cardiology, Chonnam National University Hospital, Gwangju, South Korea
^p Division of Cardiology, Inha University Hospital, Incheon, South Korea

^⁎Reprint requests: Junghan Yoon, MD, PhD, Division of Cardiology, Department of Internal Medicine, Wonju College of Medicine, Yonsei University, 162 Ilsan, Wonju, 220-060, South Korea.

Résumé

Background

The second-generation drug-eluting stents (DES) have shown superiority in many studies relating to safety and efficacy when compared with the first-generation DES. However, it is unclear whether there are differences in efficacy and safety among the second-generation DES after long-term follow-up.

Methods

This multicenter, prospective, randomized, open-labeled trial will directly compare the efficacy and safety among the patients treated with either everolimus-eluting stent (EES), zotarolimus-eluting stent with biolinx polymer (ZES-R), or biolimus-eluting stent (BES) with minimal exclusion criteria. The primary end point is a patient-oriented composite consisted of cardiac death, myocardial infarction not clearly attributable to a nontarget vessel and clinically indicated target lesion revascularization at 24-month clinical follow-up post-index procedure. With the hypothesis that “BES is non-inferior to EES” or “BES is non-inferior to ZES-R” in primary end point, approximately 2,600 patients will be assigned to one of the types of stents using a web-based randomization system.

Conclusions

The CHOICE trial will directly compare the efficacy and safety of EES, ZES-R, and BES in everyday clinical practice for long-term follow-up.

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Plan

Trial registration number: National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier #NCT01397175).

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Vol 166 - N° 2

P. 224-229 - août 2013 Retour au numéro

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Study Design and Rationale of “A Multicenter, Open-Labeled, Randomized Controlled Trial Comparing Three 2nd-Generation Drug-Eluting Stents in Real-World Practice” (CHOICE trial) - 28/07/13

Résumé

Background

Methods

Conclusions

Plan

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