The Extended Safety and Efficacy of Indobufen in Conjunction With P2Y12 Receptor Inhibitors Among Patients Undergoing Revascularization: A Meta-Analysis and Overview.

Background/Objectives: Dual antiplatelet therapy (DAPT), which combines aspirin with a P2Y12 receptor inhibitor for platelets, is crucial for the prevention of cardiac and systemic ischemic events in patients with coronary artery disease who have undergone revascularization procedures. Although indobufen is suggested as an alternative for individuals who exhibit intolerance to aspirin, the long-term safety and efficacy of indobufen-based DAPT treatment for the prevention of cardiac and systemic ischemic events in these patients remain ambiguous. This meta-analysis seeks to examine the long-term safety and efficacy of DAPT based on indobufen in the context of revascularization procedures for patients. Methods: A thorough search was performed across PubMed, Embase, the Cochrane Library, Web of Science, ClinicalTrials.gov, and CNKI, covering all records from each database's inception to October 10, 2024. Included were randomized trials analyzing oral DAPT antiplatelet agents for coronary artery disease patients who received revascularization. Two reviewers independently handled the selection process: screening articles, overview, extracting data, and assessing study quality in accordance with PRISMA guidelines. The pooled data were later subjected to analysis using a random-effects model meta-analysis. Results: The final analysis included three randomized controlled trials, which yielded the following findings regarding major adverse cardiovascular and cerebrovascular events (MACCEs): The relative risk (RR) was 1.58 (95% CI, 0.72-3.38); for BARC Type 2, 3, or 5 bleeding events, the RR was 0.35 (95% CI, 0.18-0.67); and for gastrointestinal intolerance events, the RR was 0.06 (95% CI, 0.03-0.18). Conclusions: Indobufen-based DAPT may potentially increase the risk of ischemic events without compromising safety for revascularization, as its upper RR limit exceeds 1 for MACCEs.