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)

Youngjin Youn, Junwon Lee, Sung Gyun Ahn, Seunghwan 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

Research output: Contribution to journalArticle

3 Citations (Scopus)

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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Drug-Eluting Stents
Stents
Randomized Controlled Trials
Safety
Patient Safety
Random Allocation
Polymers
Myocardial Infarction

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Youn, Youngjin ; Lee, Junwon ; Ahn, Sung Gyun ; Lee, Seunghwan ; Choi, Hyun Hee ; Choi, Hyunmin ; Choi, Cheol Ung ; Lee, Jin Bae ; Cho, Jang Hyun ; Kang, Tae Soo ; Cho, Byung Ryul ; Cha, Kwang Soo ; Kim, Moo Hyun ; Hyon, Min Su ; Cheong, Sang Sig ; Lim, Do Sun ; Han, Kyoo Rok ; Jeong, Myung Ho ; Park, Keum Soo ; Yoon, Junghan. / 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). In: American heart journal. 2013 ; Vol. 166, No. 2. pp. 224-229.
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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.",
author = "Youngjin Youn and Junwon Lee and Ahn, {Sung Gyun} and Seunghwan Lee and Choi, {Hyun Hee} and Hyunmin Choi and Choi, {Cheol Ung} and Lee, {Jin Bae} and Cho, {Jang Hyun} and Kang, {Tae Soo} and Cho, {Byung Ryul} and Cha, {Kwang Soo} and Kim, {Moo Hyun} and Hyon, {Min Su} and Cheong, {Sang Sig} and Lim, {Do Sun} and Han, {Kyoo Rok} and Jeong, {Myung Ho} and Park, {Keum Soo} and Junghan Yoon",
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Youn, Y, Lee, J, Ahn, SG, Lee, S, Choi, HH, Choi, H, Choi, CU, Lee, JB, Cho, JH, Kang, TS, Cho, BR, Cha, KS, Kim, MH, Hyon, MS, Cheong, SS, Lim, DS, Han, KR, Jeong, MH, Park, KS & 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, vol. 166, no. 2, pp. 224-229. https://doi.org/10.1016/j.ahj.2013.04.014

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). / Youn, Youngjin; Lee, Junwon; Ahn, Sung Gyun; Lee, Seunghwan; Choi, Hyun Hee; Choi, Hyunmin; Choi, Cheol Ung; Lee, Jin Bae; Cho, Jang Hyun; Kang, Tae Soo; Cho, Byung Ryul; Cha, Kwang Soo; Kim, Moo Hyun; Hyon, Min Su; Cheong, Sang Sig; Lim, Do Sun; Han, Kyoo Rok; Jeong, Myung Ho; Park, Keum Soo; Yoon, Junghan.

In: American heart journal, Vol. 166, No. 2, 01.08.2013, p. 224-229.

Research output: Contribution to journalArticle

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T1 - 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)

AU - Youn, Youngjin

AU - Lee, Junwon

AU - Ahn, Sung Gyun

AU - Lee, Seunghwan

AU - Choi, Hyun Hee

AU - Choi, Hyunmin

AU - Choi, Cheol Ung

AU - Lee, Jin Bae

AU - Cho, Jang Hyun

AU - Kang, Tae Soo

AU - Cho, Byung Ryul

AU - Cha, Kwang Soo

AU - Kim, Moo Hyun

AU - Hyon, Min Su

AU - Cheong, Sang Sig

AU - Lim, Do Sun

AU - Han, Kyoo Rok

AU - Jeong, Myung Ho

AU - Park, Keum Soo

AU - Yoon, Junghan

PY - 2013/8/1

Y1 - 2013/8/1

N2 - 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.

AB - 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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