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)

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 f...

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Bibliographic Details
Published in:The American heart journal 2013-08, Vol.166 (2), p.224-229
Main Authors: Youn, Young Jin, MD, Lee, Jun-Won, MD, Ahn, Sung Gyun, MD, Lee, Seung-Hwan, MD, Choi, Hyun Hee, MD, Choi, Hyunmin, MD, Choi, Cheol Ung, MD, Lee, Jin Bae, MD, Cho, Jang Hyun, MD, Kang, Tae Soo, MD, Cho, Byung Ryul, MD, Cha, Kwang Soo, MD, Kim, Moo Hyun, MD, Hyon, Min Su, MD, Cheong, Sang-Sig, MD, Lim, Do-Sun, MD, Han, Kyoo Rok, MD, Jeong, Myung Ho, MD, Park, Keum Soo, MD, Yoon, Junghan, MD
Format: Article
Language:English
Subjects:
Adult
Algorithms
Cardiology
Cardiovascular
Coronary Disease - mortality
Coronary Disease - therapy
Coronary vessels
Drug-Eluting Stents - adverse effects
Everolimus
Female
Heart attacks
Humans
Male
Myocardial Infarction - therapy
Prosthesis Design
Sirolimus - administration & dosage
Sirolimus - analogs & derivatives
Stents
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Summary: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.
ISSN:0002-8703
1097-6744
DOI:10.1016/j.ahj.2013.04.014