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Am Heart J. 2013 Aug;166(2):224-9. doi: 10.1016/j.ahj.2013.04.014. Epub 2013 Jun 19.

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).

Author information

1
Division of Cardiology, Yonsei University Wonju Christian Hospital, Wonju, South Korea.

Abstract

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01397175.

PMID:
23895804
DOI:
10.1016/j.ahj.2013.04.014
[Indexed for MEDLINE]

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