AHA Scientific Sessions 2026 Abstract · Nov 2, 2026
Efficacy and Safety of Asundexian in Cardiovascular Diseases, Systemic Review and Meta-Analysis
By Siddiqui E, Khan M, ahmad N et al.
Background: Factor XIa inhibition has emerged as a promising antithrombotic strategy that may reduce thromboembolic events while minimizing bleeding complications. We performed an systematic review and meta-analysis to evaluate the efficacy and safety of asundexian across cardiovascular populations. Methods: PubMed, Embase, Scopus, and CENTRAL were searched through April 2026. Randomized controlled trials comparing asundexian with placebo or active anticoagulant therapy in adults with cardiovascular disease were included. Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled using random-effects models. Risk of bias was assessed using RoB 2 and certainty of evidence using GRADE. Results: Five randomized controlled trials involving 31,301 participants were included. Asundexian did not significantly affect all-cause mortality compared with control (RR 0.98, 95% CI 0.85–1.14) or ischemic stroke (RR 1.33, 95% CI 0.66–2.66). No significant differences were observed for cardiovascular death (RR 0.88, 95% CI 0.74–1.04), ISTH major bleeding (RR 0.79, 95% CI 0.30–2.09), major or clinically relevant non-major bleeding (RR 0.77, 95% CI 0.37–1.61), serious adverse events (RR 0.98, 95% CI 0.91–1.05), or overall adverse events (RR 0.99, 95% CI 0.97–1.01). Significant heterogeneity was observed for several thromboembolic and bleeding outcomes. Sensitivity analyses excluding an influential trial reduced heterogeneity substantially and demonstrated a lower risk of stroke or systemic embolism (RR 0.74, 95% CI 0.65–0.84). Conclusions: Across 31,301 patients with cardiovascular disease, asundexian demonstrated a safety profile comparable to control without significant effects on mortality or major bleeding. Sensitivity analyses suggest a potential reduction in thromboembolic events; however, findings remain influenced by study-level heterogeneity. Further adequately powered trials are needed to define the role of factor XIa inhibition in cardiovascular prevention.