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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.

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제1저자 이희선, 구본권 · 교신저자 김효수

소속 (14)
  1. 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.
  2. Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea; Cardiovascular Center, Seoul National University Hospital, Seoul, Republic of Korea.
  3. Ulsan University Hospital, Ulsan, Republic of Korea.
  4. CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea.
  5. Korea University Guro Hospital, Seoul, Republic of Korea.
  6. Chungbuk National University, College of Medicine, Cheongju, Republic of Korea.
  7. National Health Insurance Corporation Ilsan Hospital, Goyang, Republic of Korea.
  8. Wonkwang University Hospital, Iksan, Republic of Korea.
  9. Keimyung University Dongsan Medical Center, Daegu, Republic of Korea.
  10. Kangbuk Samsung Medical Center, Sungkyunkwan University, Seoul, Republic of Korea.
  11. Yeungnam University Medical Center, Daegu, Republic of Korea.
  12. Dong-A University Hospital, Busan, Republic of Korea.
  13. Kangnam Sacred Heart Hospital, Hallym University, Seoul, Republic of Korea.
  14. 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