Study protocol for a randomised controlled trial: harmonising optimal strategy for treatment of coronary artery stenosis - coronary intervention with next-generation drug-eluting stent platforms and abbreviated dual antiplatelet therapy (HOST-IDEA) trial

Chi-Hoon Kim, Jung-Kyu Han, Han-Mo Yang, Kyung Woo Park, Hae-Young Lee, Hyun-Jae Kang, Bon-Kwon Koo, Namho Lee, Tae-Joon Cha, Tae-Hyun Yang, Myung-Ho Jeong, Myeong-Ho Yoon, Seung Uk Lee, Seung Jin Lee, Jin Won Kim, Jin-Man Cho, Kyoo-Rok Han, Wook Bum Pyun, Hyo-Soo Kim, Chi-Hoon Kim, Jung-Kyu Han, Han-Mo Yang, Kyung Woo Park, Hae-Young Lee, Hyun-Jae Kang, Bon-Kwon Koo, Namho Lee, Tae-Joon Cha, Tae-Hyun Yang, Myung-Ho Jeong, Myeong-Ho Yoon, Seung Uk Lee, Seung Jin Lee, Jin Won Kim, Jin-Man Cho, Kyoo-Rok Han, Wook Bum Pyun, Hyo-Soo Kim

Abstract

Introduction: We have recently seen the introduction of newer generation drug-eluting stents with ultrathin struts that use advanced polymer technologies. However, the efficacy and safety of these newest stents have not yet been fully explored. In addition, there are still controversies over the optimal duration of dual antiplatelet therapy (DAPT) after stent implantation, particularly for ultrathin stents with the newest polymer technologies.

Methods and analysis: The HOST-IDEA trial is a randomised, open-label, multicentre, non-inferiority trial and the first study to directly compare two of these ultrathin sirolimus-eluting stents: Orsiro stent with biodegradable polymer, and polymer-free Coroflex ISAR (CX-ISAR) stent. This study has a scheme of 2×2 factorial design according to the stent type and DAPT duration (3 vs 12 months). A total of 2152 patients will be randomised and stratified to demonstrate the non-inferiority of CX-ISAR to Orsiro, or of the abbreviated DAPT duration to the conventional 12 months (both in 1:1 ratio). For the comparison of stent type, the primary endpoint is target lesion failure (TLF), which is a composite of cardiac death, target vessel-related myocardial infarction and clinically driven target lesion revascularisation. For the comparison of DAPT duration, the net adverse clinical event is the coprimary endpoint, which is defined as a composite of TLF, definite/probable stent thrombosis and major bleeding.

Ethic approval and dissemination: All the institutions involved in this study are required to have ethical approval prior to patient enrolment. This multicentre study will recruit patients through competitive registration, but institutions that have not yet obtained ethical approvals have made it impossible to enrol patients in a centralised web database. The final results will be presented at relevant international conferences and will be materialised in the form of papers.

Trial registration number: NCT02601157; Pre-results.

Keywords: antiplatelet therapy; polymer; stent.

Conflict of interest statement

Competing interests: None declared.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
Study outline and randomization scheme.

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