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.
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.
['Kim|Chi-Hoon|CH|', 'Han|Jung-Kyu|JK|', 'Yang|Han-Mo|HM|', 'Park|Kyung Woo|KW|', 'Lee|Hae-Young|HY|', 'Kang|Hyun-Jae|HJ|', 'Koo|Bon-Kwon|BK|', 'Lee|Namho|N|', 'Cha|Tae-Joon|TJ|', 'Yang|Tae-Hyun|TH|', 'Jeong|Myung-Ho|MH|', 'Yoon|Myeong-Ho|MH|', 'Lee|Seung Uk|SU|', 'Lee|Seung Jin|SJ|', 'Kim|Jin Won|JW|', 'Cho|Jin-Man|JM|', 'Han|Kyoo-Rok|KR|', 'Pyun|Wook Bum|WB|', 'Kim|Hyo-Soo|HS|']
D020341:Absorbable Implants D002985:Clinical Protocols D017023:Coronary Angiography D023921:Coronary Stenosis D054855:Drug-Eluting Stents D004867:Equipment Design D005260:Female D006801:Humans D007166:Immunosuppressive Agents D008297:Male D009203:Myocardial Infarction D062645:Percutaneous Coronary Intervention D010975:Platelet Aggregation Inhibitors D011108:Polymers D020123:Sirolimus D013927:Thrombosis
stent antiplatelet therapy polymer