Abstract 12577: The Efficacy and Safety of Third Generation P2Y12 Inhibitors in Women versus Men: A Sex-Specific Meta-Analysis

Abstract

Introduction: Sex-specific differences in the response to antiplatelet therapies have been described. Whether women and men derive comparable efficacy and safety from intensification of antiplatelet therapy with 3rd generation P2Y12 inhibitors is uncertain. Methods: A sex-specific meta-analysis was conducted of phase III or IV randomized trials that examined the efficacy and safety of 3 rd generation P2Y12 inhibitors in patients with CAD, including prasugrel, ticagrelor, and cangrelor. Five trials were included that enrolled a total of 19,536 women and 52,043 men based on published data. MACE was defined as the primary endpoint for each trial (components included CV death and MI for all trials). The safety endpoint was defined as non-CABG major bleeding for each trial. Data used for analyses were obtained from published reports. Results: Administration of a 3 rd generation P2Y12 inhibitor significantly reduced the risk of MACE by 14% in women (HR 0.86, 95% CI 0.77-0.95) and by 17% in men (HR 0.83, 95% CI 0.79-0.88) with no heterogeneity in the magnitude of effect (P interaction =0.66; Figure). The 3 rd generation P2Y12 inhibitors increased the risk of non-CABG major bleeding by 38% in women (HR 1.38, 95% CI 1.05-1.81) and by 50% in men (HR 1.50, 95% CI 1.09-2.07), again without heterogeneity (P interaction = 0.88). Conclusions: In randomized trials, the efficacy and safety of the 3 rd generation P2Y12 inhibitors were comparable between men and women. Since women remain undertreated with guideline-recommended therapies, these data support the administration of 3 rd generation P2Y12 inhibitors in women with appropriate indications for use.