Aspirin versus clopidogrel for chronic maintenance monotherapy after percutaneous coronary intervention (HOST-EXAM): an investigator-initiated, prospective, randomised, open-label, multicentre trial.

Abstract

BACKGROUND:

Optimal antiplatelet monotherapy during the chronic maintenance period in patients who undergo coronary stenting is unknown. We aimed to compare head to head the efficacy and safety of aspirin and clopidogrel monotherapy in this population.

METHODS:

We did an investigator-initiated, prospective, randomised, open-label, multicentre trial at 37 study sites in South Korea. We enrolled patients aged at least 20 years who maintained dual antiplatelet therapy without clinical events for 6-18 months after percutaneous coronary intervention with drug-eluting stents (DES). We excluded patients with any ischaemic and major bleeding complications. Patients were randomly assigned (1:1) to receive a monotherapy agent of clopidogrel 75 mg once daily or aspirin 100 mg once daily for 24 months. The primary endpoint was a composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and Bleeding Academic Research Consortium (BARC) bleeding type 3 or greater, in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02044250.

FINDINGS:

Between March 26, 2014, and May 29, 2018, we enrolled 5530 patients. 5438 (98·3%) patients were randomly assigned to either the clopidogrel group (2710 [49·8%]) or to the aspirin group (2728 [50·2%]). Ascertainment of the primary endpoint was completed in 5338 (98·2%) patients. During 24-month follow-up, the primary outcome occurred in 152 (5·7%) patients in the clopidogrel group and 207 (7·7%) in the aspirin group (hazard ratio 0·73 [95% CI 0·59-0·90]; p=0·0035).

INTERPRETATION:

Clopidogrel monotherapy, compared with aspirin monotherapy during the chronic maintenance period after percutaneous coronary intervention with DES significantly reduced the risk of the composite of all-cause death, non-fatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and BARC bleeding type 3 or greater. In patients requiring indefinite antiplatelet monotherapy after percutaneous coronary intervention, clopidogrel monotherapy was superior to aspirin monotherapy in preventing future adverse clinical events.

FUNDING:

ChongKunDang, SamJin, HanMi, DaeWoong, and the South Korea Ministry of Health and Welfare.

• Authors: Bon-Kwon Koo, Jeehoon Kang, Kyung Woo Park, Tae-Min Rhee, Han-Mo Yang, Ki-Bum Won, Seung-Woon Rha, Jang-Whan Bae, Nam Ho Lee, Seung-Ho Hur, Junghan Yoon, Tae-Ho Park, Bum Soo Kim, Sang Wook Lim, Yoon Haeng Cho, Dong Woon Jeon, Sang-Hyun Kim, Jung-Kyu Han, Eun-Seok Shin, Hyo-Soo Kim, HOST-EXAM investigators
• Journal: Lancet (London, England) (Lancet) Vol. 397 Issue 10293 Pg. 2487-2496 (06 26 2021) ISSN: 1474-547X [Electronic] England
• PMID: 34010616 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2021 Elsevier Ltd. All rights reserved.

Chemical References

• Platelet Aggregation Inhibitors
• Clopidogrel
• Aspirin

Topics

• Aged
• Aspirin (therapeutic use)
• Clopidogrel (therapeutic use)
• Coronary Artery Disease (drug therapy, surgery)
• Drug-Eluting Stents
• Female
• Humans
• Male
• Middle Aged
• Percutaneous Coronary Intervention (methods)
• Platelet Aggregation Inhibitors (therapeutic use)
• Prospective Studies
• Republic of Korea