Clopidogrel Effective for Reducing Risk for Thrombotic Events and Major Bleeding After PCI

Clopidogrel is associated with a decreased risk for thrombotic events and major bleeding compared with aspirin monotherapy in patients who have had percutaneous coronary intervention (PCI), according to a study in the Journal of the American College of Cardiology.

The post hoc analysis of the HOST-EXAM (Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases-Extended Antiplatelet Monotherapy; ClinicalTrials.gov Identifier: NCT02044250) trial evaluated whether the benefits of clopidogrel vs aspirin were consistent among high clinical risk situations with use of the Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention (TRS 2°P) and the dual antiplatelet therapy (DAPT) scores.

Participants received PCI with drug-eluting stents and maintained DAPT after PCI without clinical events for 6 to 18 months. They were randomly assigned in a 1:1 ratio to clopidogrel (75 mg once daily) or aspirin (100 mg once daily) between March 26, 2014, and May 29, 2018.

Follow-up was scheduled at 12 and 24 months (±3 months). The primary composite endpoint included all-cause death, nonfatal myocardial infarction, stroke, readmission owing to acute coronary syndrome, and major bleeding events.

The analysis included 5403 patients (median age, 64.0 years; 74.7% men). The primary composite endpoint occurred in 357 (6.6%) patients, the thrombotic composite endpoint in 243 patients (4.5%), and major bleeding in 86 (1.6%) patients.

Clopidogrel monotherapy was associated with a reduced risk for the primary composite endpoint (hazard ratio [HR], 0.73; 95% CI, 0.59-0.90; P =.003), the thrombotic composite endpoint (HR, 0.68; 95% CI, 0.52-0.87; P =.003), and major bleeding (HR, 0.63; 95% CI, 0.41-0.97; P =.035) vs aspirin monotherapy.

The trends for clopidogrel’s benefits were consistent for the primary composite endpoint after outcomes were compared between aspirin and clopidogrel based on the TRS 2°P (HR, 0.65; 95% CI, 0.44-0.96; P =.032 in the high TRS 2°P group; HR, 0.77; 95% CI, 0.60-0.99; P =.042 in the low TRS 2°P group; P_interaction =.454).

The clopidogrel group’s lower event rate for the primary endpoint was consistent in the high-DAPT score group (HR, 0.68; 95% CI, 0.46-1.00; P =.051) and the low-DAPT score group (HR, 0.75; 95% CI, 0.59-0.96; P =.025) without significant interaction (P_interaction =.662). A similar trend occurred for the thrombotic composite endpoint and major bleeding and individual outcome components with no interaction.

Limitations of the study include the open-label design and lack of information on the specific interventions and modifications for clinical risk factors during the follow-up. Also, the number of events was small and there may be limited generalizability.

“Compared with aspirin monotherapy, the benefit of clopidogrel in reducing the composite thrombotic and bleeding outcomes was consistent and maintained in patients with high and low clinical, ischemic, and bleeding risks,” wrote the investigators.

Disclosure: Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

This article originally appeared on The Cardiology Advisor