ABSTRACT NUMBER: ESOC2026A2114 STROKE PREVENTION IN WOMEN (SERENE): AN INDIVIDUAL PATIENT DATA LEVEL META-ANALYSIS OF FOUR RANDOMIZED CONTROLLED TRIALS ON SECONDARY STROKE PREVENTION IN WOMEN

Abstract Background and aims Women experience worse outcomes after stroke than men. Evidence guiding optimal secondary stroke prevention (SSP) in women remains limited. Using individual patient data from large randomized SSP trials, we evaluated gender-specific risks of recurrent stroke and the potential heterogeneity in antithrombotic treatment effects. Methods SERENE is an individual participant–level meta-analysis of four randomized trials comparing oral anticoagulation with antiplatelet therapy for SSP (DATAS-II, AXIOMATIC, PACIFIC-STROKE, and NAVIGATE-ESUS). The primary outcome was recurrent stroke in women versus men; secondary outcomes included all-cause mortality, major adverse cardiovascular events (MACE), and bleeding. Analyses were adjusted for confounders and were performed on the intention-to-treat populations. Results Among 11,692 patients (37.4% women), 58.4%, anticoagulation and 42.2% received antiplatelets. Women were older, more hypertensive, smoked less, and had less CAD and PAD than men. Over a median follow-up of 7.9 months, women had lower rates of recurrent stroke (4.24% vs. 5.37%; HR 0.83, 95% CI 0.68–0.96; P = 0.014) and MACE (4.97% vs. 6.36%; HR 0.80, 95% CI 0.68–0.93; P < 0.01) compared with men, with no differences in all-cause mortality or major bleeding. Women experienced fewer ischemic (HR 0.83, 95% CI 0.70–1.00; P = 0.045) and hemorrhagic strokes (HR 0.19, 95% CI 0.04–0.81; P = 0.02). Gender differences in these outcomes were consistent across antithrombotic treatment strategies, and no heterogeneity in treatment effect was observed. Conclusions In a large cohort of SSP trials, women demonstrated lower rates of recurrent stroke and MACE than men, with no differences in mortality or bleeding. These findings were consistent across antithrombotic strategies. Conflict of interest Luciana Catanese, angela wang, Lizhen Xu and Abhilekh Srivastava: nothing to disclose; Kanjana Perera: Bayer AG grant support and honoraria and CIHR grant support, Mukul Sharma: Bayer AG grant support and honoraria, Ashkan Shoamanesh: Bayer AG grant support and honoraria. Executive committee of Pacific and Navigate ESUS.