Efficacy and safety of indobufen- versus aspirin-based dual antiplatelet therapy following percutaneous coronary intervention: a systematic review and meta-analysis

Background: Indobufen is a potential alternative to aspirin in dual antiplatelet therapy (DAPT) regimens after percutaneous coronary intervention (PCI) due to its superior safety profile and comparable efficacy. This systematic review and meta-analysis compares the efficacy and safety of indobufen-based DAPT versus aspirin-based DAPT following PCI. Methods: A systematic literature search was conducted on PubMed, Embase, Cochrane, and ClinicalTrials.gov using MeSH terms and keywords related to “Percutaneous Coronary Intervention,” “Platelet Aggregation Inhibitors,” and “Aspirin,” from inception to March 2026. Randomized controlled trials (RCTs) and cohort studies assessing indobufen post-PCI were included. A random-effects meta-analysis was performed using the Mantel–Haenszel method in RevMan to pool risk ratios (RR) and 95% confidence intervals (CIs). Results: Six studies comprising 13 044 patients were included. Indobufen use significantly reduced Bleeding Academic Research Consortium (BARC) type 2 bleeding (RR = 0.57, 95% CI 0.33–0.97), BARC type 2, 3, and 5 bleeding (RR = 0.63, 95% CI 0.45–0.90), and gastrointestinal adverse events (RR = 0.64, 95% CI 0.51–0.80). No significant differences were observed between both groups for cardiac death (RR = 1.23, 95% CI 0.72–2.12), myocardial infarction (RR = 0.92, 95% CI 0.52–1.64), ischemic stroke (RR = 0.90, 95% CI 0.58–1.39), stent thrombosis (RR = 1.12, 95% CI 0.45–2.82), and BARC type 3 or 5 bleeding (RR = 0.83, 95% CI 0.57–1.22). Conclusion: Indobufen demonstrates comparable antiplatelet efficacy to aspirin while improving safety. Further large-scale, high-quality RCTs are warranted to solidify evidence and inform future guidelines, particularly to assess the role of indobufen in patients at high bleeding risk.