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

Heesun Lee, Bon Kwon Koo, Kyung Woo Park, Eun Seok Shin, Sang Wook Lim, Seung-Woon Rha, Jang Whan Bae, Dong Woon Jeon, Seok Kyu Oh, Seung Ho Hur, Bum Su Kim, Jung Hee Lee, Tae Ho Park, Nam Ho Lee, Hyo Soo Kim

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)17-25
Number of pages9
JournalAmerican Heart Journal
Volume185
DOIs
Publication statusPublished - 2017 Mar 1

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clopidogrel
Drug-Eluting Stents
Coronary Stenosis
Aspirin
Randomized Controlled Trials
Percutaneous Coronary Intervention
Therapeutics
Stents
Safety
Platelet Aggregation Inhibitors
Acute Coronary Syndrome
Random Allocation
Cause of Death
Thrombosis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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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. / Lee, Heesun; Koo, Bon Kwon; Park, Kyung Woo; Shin, Eun Seok; Lim, Sang Wook; Rha, Seung-Woon; Bae, Jang Whan; Jeon, Dong Woon; Oh, Seok Kyu; Hur, Seung Ho; Kim, Bum Su; Lee, Jung Hee; Park, Tae Ho; Lee, Nam Ho; Kim, Hyo Soo.

In: American Heart Journal, Vol. 185, 01.03.2017, p. 17-25.

Research output: Contribution to journalArticle

Lee, Heesun ; Koo, Bon Kwon ; Park, Kyung Woo ; Shin, Eun Seok ; Lim, Sang Wook ; Rha, Seung-Woon ; Bae, Jang Whan ; Jeon, Dong Woon ; Oh, Seok Kyu ; Hur, Seung Ho ; Kim, Bum Su ; Lee, Jung Hee ; Park, Tae Ho ; Lee, Nam Ho ; Kim, Hyo Soo. / 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. In: American Heart Journal. 2017 ; Vol. 185. pp. 17-25.
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