Edoxaban Noninferior to Warfarin in Atrial Fibrillation After TAVI

September 2, 2021
By Walter Alexander VIRTUAL -- September 1, 2021 -- Edoxaban is noninferior to warfarin in regards to adverse events among patients with atrial fibrillation after transcatheter aortic valve implantation (TAVI), according to a study presented at the Virtual 2021 European Society of Cardiology (ESC) Congress. However, major bleeding incidence was higher with edoxaban than with vitamin K antagonists, said George Dangas, MD, Icahn School of Medicine at Mount Sinai, New York, New York. Because of the high prevalence (20%-40%) of pre-existing or new-onset atrial fibrillation after TAVI, stroke prophylaxis with oral anticoagulation is recommended. However, few data comparing the safety and efficacy of direct-acting oral anticoagulants versus vitamin K antagonists after TAVI appear in the literature. To address that uncertainty, investigators compared safety and efficacy of the direct-acting oral anticoagulant edoxaban (60 mg/day) versus vitamin K antagonists (including warfarin) after TAVI. The ENVISAGE-TAVI AF trial comprised 1,426 patients with atrial fibrillation treated at 173 medical centres in 14 countries on 3 continents. The primary efficacy endpoint was a composite of net adverse clinical events, including all-cause death, myocardial infarction, ischaemic stroke, systemic thromboembolism, valve thrombosis, and major bleeding. The primary safety endpoint was the incidence of major bleeding. After an average follow-up of 18 months, edoxaban was found to be noninferior to vitamin K antagonists for the composite efficacy endpoint, with an annual rate of 17.5% versus 16.5%, respectively (hazard ratio [HR] = 1.05; 95% confidence interval [CI], 0.85-1.31; P = .01 for noninferiority). The risk for major bleeding was higher in the edoxaban group (9.7% vs 7.0%; HR = 1.40; 95% CI, 1.03-1.91). Major bleeding rates in the edoxaban group were driven by major gastrointestinal bleeding (1 fatal bleed). Dr. Dangas noted that among patients who needed dose-adjustment and received edoxaban 30 mg, net adverse clinical events and major bleeding rates were similar between groups. Major bleeding in patients with prespecified antiplatelet therapy was also higher with edoxaban. Major bleeding differences started emerging after several months and continued to diverge. “The hazard is with long-term use,” said Dr. Dangas. “It seems that lowering the edoxaban dosage when indicated and avoiding patients on mandatory antiplatelet therapy is reasonable safety advice from a clinical point of view.” A more-detailed bleeding analysis is forthcoming. [Presentation title: Edoxaban Noninferior to Warfarin for Adverse Events After Heart Valve Replacement]