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.

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.

• Authors: 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, HOST-EXAM investigators
• Journal: American heart journal (Am Heart J) Vol. 185 Pg. 17-25 (Mar 2017) ISSN: 1097-6744 [Electronic] United States
• PMID: 28267471 (Publication Type: Comparative Study, Journal Article, Multicenter Study)
• Copyright: Copyright © 2016 Elsevier Inc. All rights reserved.

Chemical References

• Platelet Aggregation Inhibitors
• Clopidogrel
• Ticlopidine
• Aspirin

Topics

• 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