Clinical Outcomes and Safety Profiles of Generic Versus Brand-Name Clopidogrel in Patients Following Coronary Artery Stent Placement

Abstract

Coronary artery disease remains a significant global health issue and is a leading cause of mortality. Dual antiplatelet therapy, including clopidogrel, is essential for preventing stent thrombosis after coronary artery stenting. This study assessed the comparative efficacy and safety of generic versus brand-name clopidogrel in a large Taiwanese cohort. A retrospective cohort study was conducted using the National Health Insurance database, identifying patients who underwent coronary stenting and received either generic or brand-name clopidogrel between January 1, 2008, and December 31, 2021. Propensity score matching was employed to balance baseline characteristics. The primary efficacy outcome was a composite of myocardial infarction, ischemic stroke, or cardiovascular death over a two-year follow-up. The primary safety outcome was major bleeding requiring hospitalization. A total of 211,509 patients were included, of which 2686 received generic clopidogrel and 208,823 received brand-name clopidogrel. After matching, 2686 patients from each group were analyzed. The hazard ratio for the primary efficacy outcome was 0.92 (95% confidence interval: 0.78–1.10), indicating no significant difference between the two groups. The subdistribution hazard ratio for the primary safety outcome was 1.06 (95% confidence interval: 0.84–1.33), suggesting no significant difference in bleeding risk. Subgroup analyses showed consistent results across various patient demographics and clinical conditions. In conclusion, among patients undergoing coronary stenting, the risks of ischemic and bleeding events were comparable between those receiving generic and brand-name clopidogrel.