Indobufen Versus Aspirin in Acute Ischemic Stroke: A Systematic Review and Meta-Analysis

Background: Acute ischemic stroke (AIS) is a major cause of death and disability worldwide. Early antiplatelet therapy reduces recurrence and improves outcomes. Although aspirin is standard treatment, its use is limited by bleeding risk. Indobufen, a reversible cyclooxygenase inhibitor with shorter platelet inhibition, may offer a safer alternative. Objective: To compare the efficacy and safety of indobufen versus aspirin in patients with AIS. Methods: A systematic review and meta-analysis was performed according to PRISMA guidelines. PubMed, Embase, Cochrane Library, and ScienceDirect were searched through February 2026 for randomized controlled trials comparing indobufen with aspirin in adults with AIS. Primary outcomes were functional outcomes (modified Rankin Scale), neurological improvement (NIHSS) at 90 days, recurrent ischemic stroke at 90 days, and composite vascular events. Secondary outcomes included bleeding and other adverse events. Pooled estimates were calculated using fixed- or random-effects models based on heterogeneity. The risk of bias was assessed using Cochrane RoB 2.0. Results: Four randomized controlled trials (278 records screened) were included. Indobufen showed no significant difference versus aspirin in NIHSS improvement at 90 days (MD: 0.01, 95% CI: −0.07 to 0.09) or recurrent ischemic stroke (OR: 0.54, 95% CI: 0.05-5.61). However, indobufen significantly improved modified Rankin Scale outcomes (MD: −1.11, 95% CI: −1.32 to −0.90) and reduced moderate-to-severe bleeding at 3 months (OR: 0.57, 95% CI: 0.35-0.92). Conclusions: Indobufen provides efficacy comparable to aspirin, with better functional outcomes and lower short-term bleeding risk, supporting its potential as an alternative antiplatelet therapy in AIS. Larger, international, multicenter trials are warranted. Larger, high-quality, multicenter international trials are warranted to confirm these findings.