Why the study?
It remained unclear whether the bleeding and thromboembolic benefits of dabigatran dual therapy versus warfarin triple therapy after PCI in nonvalvular AF were consistent between males and females.
Does dual therapy with dabigatran and a P2Y12 inhibitor reduce bleeding without increasing thromboembolic events compared to triple therapy with warfarin in male and female patients with nonvalvular atrial fibrillation undergoing PCI?
Does dual therapy with dabigatran and a P2Y12 inhibitor reduce bleeding without increasing thromboembolic events compared to triple therapy with warfarin in male and female patients with nonvalvular atrial fibrillation undergoing PCI?
Dual antithrombotic therapy with dabigatran reduces bleeding risk compared to triple therapy with warfarin in patients with atrial fibrillation undergoing PCI, with consistent safety and efficacy benefits observed in both men and women.
Sex-specific consistency of dabigatran dual therapy bleeding reduction in AF-PCI remains uncertain; leaves open dedicated sex-stratified trials before practice change.
Background The RE‐DUAL PCI trial demonstrated that in patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), dual therapy with dabigatran and a P2Y12 inhibitor, either clopidogrel or ticagrelor, reduced the risk of bleeding without an increased risk of thromboembolic events as compared to triple therapy with warfarin in addition to a P2Y12 inhibitor and aspirin. What remains unclear is whether this effect is consistent between males and females undergoing PCI. Hypothesis The reduction in risk of bleeding without increased risk of thromboembolic events with dual therapy with dabigatran and a P2Y12 inhibitor in comparison to triple therapy with warfarin, a P2Y12 inhibitor and aspirin is consistent in females and males. Methods The primary safety endpoint was the first International Society on Thrombosis and Hemostasis (ISTH) major bleeding event (MBE) or clinically relevant non‐major bleeding event (CRNMBE). The efficacy endpoint was the composite of death, thromboembolic event (stroke, myocardial infarction, and systemic embolism) or unplanned revascularization. Cox proportional hazard regression analyses were applied to calculate corresponding hazard ratios and interaction p values for each endpoint. Results A total of 655 women and 2070 men were enrolled. The risk of major or CRNM bleeding was lower with both dabigatran 110 mg dual therapy and dabigatran 150 mg dual therapy compared with warfarin triple therapy in female and male patients (for 110 mg: females: HR 0.69, 95% CI 0.47–1.01, males: HR 0.46, 95% CI 0.37–0.59, interaction p value: 0.084 and for 150 mg: females HR 0.74, 95% CI 0.48–1.16, males HR 0.71, 95% CI 0.56–0.90, interaction p value: 0.83). There was also no detectable difference in the composite efficacy endpoint of death, thromboembolic events or unplanned revascularization between dabigatran dual therapy and warfarin triple therapy, with no statistically significant interaction between sex and treatment (interaction p values: 0.73 and 0.72, respectively). Conclusions Consistent with the overall study results, the risk of bleeding was lower with dabigatran 110 mg and 150 mg dual therapy compared with warfarin triple therapy, and risk of thromboembolic events was comparable with warfarin triple therapy independent of the patient's sex.
No takes yet. Share an insight, caveat, or question.
Eccleston et al. (2021) studied this question.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: