Safety and Efficacy of Aspirin and Indobufen in the Treatment of Atherosclerotic Diseases: Systematic Review and Meta-Analysis.

Abstract

Background: The pathogenesis of atherosclerotic thrombosis primarily involves platelet activation and aggregation, making antiplatelet therapy the cornerstone of treatment for such diseases.

Objective: This meta-analysis aimed to compare the safety and efficacy of aspirin and indobufen in antiplatelet therapy for patients with atherosclerotic diseases.

Methods: We searched the Cochrane Library, PubMed, Embase, Web of Science, and the Chinese Wanfang databases. The literature was screened according to predefined inclusion and exclusion criteria. Risk ratio (RR) was used to assess the magnitude of risk associated with exposure and our inclusion criteria are as follows: (1) the study population comprised adults (aged 18 years and older) with coronary heart disease caused by coronary artery atherosclerosis or stroke caused by intracranial atherosclerosis; (2) the intervention was represented by indobufen in the study groups versus aspirin in the control groups; (3) the primary outcome was the incidence of major adverse cardiovascular and cerebrovascular events or any bleeding or Bleeding Academic Research Consortium 2/3/5 bleeding; (4) the secondary outcomes were cardiovascular death, myocardial infarction, and ischemic stroke; adverse cardiovascular events such as coronary thrombus reformation, heart failure, myocardial infarction, stroke, angina pectoris, and cardiovascular death; stroke; myocardial infarction; and cardiovascular death; and (5) the studies were randomized clinical trials with either crossover or parallel designs or prospective observational trials.

Results: Eighteen trials with a total of 12,981 patients were included in this study. Compared to aspirin, indobufen reduced the risk of (1) bleeding events (RR 0.54, 95% CI 0.41-0.71; P<.0001), (2) Bleeding Academic Research Consortium 2/3/5 bleeding (RR 0.50, 95% CI 0.26-0.94; P=.03), (3) adverse cardiovascular events (RR 0.43, 95% CI 0.30-0.61; P<.00001), and (4) myocardial infarction (RR 0.60, 95% CI 0.41-0.89; P=.01). However, there were no significant differences between the 2 groups in terms of major adverse cardiovascular and cerebrovascular events, stroke, or cardiovascular mortality.

Conclusions: Compared with aspirin, indobufen demonstrated better safety and was not inferior to aspirin in terms of efficacy, with superior results in some aspects (eg, fewer risks of adverse cardiovascular events and myocardial infarction). Further studies with larger sample sizes or longer follow-up periods may provide additional evidence.