Am Heart J. 2017;185:17-25.
A randomized clinical trial comparing long-term clopidogrel vs aspirin monotherapy beyond dual antiplatelet therapy after drug-eluting coronary stent implantation: Design and rationale of the Harmonizing Optimal Strategy for Treatment of coronary artery stenosis-Extended Antiplatelet Monotherapy (HOST-EXAM) trial.
제1저자 이희선, 구본권 · 교신저자 김효수
소속 (14)
- Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea; Healthcare System Gangnam Center, Seoul National University Hospital, Seoul, Republic of Korea.
- Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea; Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
- Ulsan University Hospital, Ulsan, Republic of Korea.
- CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea.
- Korea University Guro Hospital, Seoul, Republic of Korea.
- Chungbuk National University, College of Medicine, Cheongju, Republic of Korea.
- National Health Insurance Corporation Ilsan Hospital, Goyang, Republic of Korea.
- Wonkwang University Hospital, Iksan, Republic of Korea.
- Keimyung University Dongsan Medical Center, Daegu, Republic of Korea.
- Kangbuk Samsung Medical Center, Sungkyunkwan University, Seoul, Republic of Korea.
- Yeungnam University Medical Center, Daegu, Republic of Korea.
- Dong-A University Hospital, Busan, Republic of Korea.
- Kangnam Sacred Heart Hospital, Hallym University, Seoul, Republic of Korea.
- Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea; Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea. Electronic address: usahyosoo@gmail.com.
Abstract
UNLABELLED Percutaneous coronary intervention (PCI) has been developed by drug-eluting stent (DES), but stent implantation has brought the issue of stent thrombosis and optimal antiplatelet therapy. Guidelines recommend at least 6- to 12 months of dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor such as clopidogrel. Beyond DAPT after PCI with DES, however, there has been still a debate for antiplatelet regimen. Therefore, we report on the upcoming HOST-EXAM trial (NCT02044250), which will evaluate the efficacy and safety of aspirin and clopidogrel monotherapies beyond DAPT after DES implantation.
TRIAL DESIGN The HOST-EXAM is a prospective, randomized, open-label, multicenter, comparative effectiveness trial, to compare between clopidogrel (75 mg once daily) and aspirin (100 mg once daily) as long-term antiplatelet agents. A total of 5,530 patients with no clinical events during combined antiplatelet therapy for 12±6 months after index PCI will be screened, enrolled, and randomized to either group (1:1 ratio) receiving antiplatelet monotherapy for 2 years. The primary endpoint will be the rate of clinical events defined as a composite of all-cause death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, or major bleeding at 24 months after randomization.
CONCLUSIONS The HOST-EXAM will be the first large-scale randomized controlled study to directly compare the efficacy and safety of long-term antiplatelet monotherapy beyond DAPT after DES implantation. This study will provide clinical evidence to establish optimal regimen for long-term antiplatelet therapy after DES implantation.
Copyright © 2016 Elsevier Inc. All rights reserved.
그 밖의 정보
- 출판 형태
- Comparative Study, Journal Article, Multicenter Study
- 저널
- American heart journal · eISSN 1097-6744
- 전자 출판
- 2016-12-09
- MeSH
- Acute Coronary Syndrome / epidemiology · Aspirin / administration & dosage · Cause of Death · Clopidogrel · Coronary Stenosis / therapy · Drug Therapy, Combination · Drug-Eluting Stents* · Hemorrhage / chemically induced · Humans · Mortality · Myocardial Infarction / epidemiology · Percutaneous Coronary Intervention* · Platelet Aggregation Inhibitors / administration & dosage · Stroke / epidemiology · Ticlopidine / administration & dosage / analogs & derivatives · Time Factors · Treatment Outcome
- Substances
- Platelet Aggregation Inhibitors · Clopidogrel · Ticlopidine · Aspirin