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)

Young Jin Youn, Jun Won Lee, Sung Gyun Ahn, Seung Hwan Lee, Hyun Hee Choi, Hyunmin Choi, Cheol Ung Choi, Jin Bae Lee, Jang Hyun Cho, Tae Soo Kang, Byung Ryul Cho, Kwang Soo Cha, Moo Hyun Kim, Min Su Hyon, Sang Sig Cheong, Do Sun Lim, Kyoo Rok Han, Myung Ho Jeong, Keum Soo Park, Junghan Yoon

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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.

Original languageEnglish
Pages (from-to)224-229
Number of pages6
JournalAmerican heart journal
Volume166
Issue number2
DOIs
Publication statusPublished - 2013 Aug 1

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All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Youn, Y. J., Lee, J. W., Ahn, S. G., Lee, S. H., Choi, H. H., Choi, H., Choi, C. U., Lee, J. B., Cho, J. H., Kang, T. S., Cho, B. R., Cha, K. S., Kim, M. H., Hyon, M. S., Cheong, S. S., Lim, D. S., Han, K. R., Jeong, M. H., Park, K. S., & Yoon, J. (2013). 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). American heart journal, 166(2), 224-229. https://doi.org/10.1016/j.ahj.2013.04.014