Edoxaban noninferior to vitamin K antagonists for atrial fibrillation after successful TAVR: ENVISAGE-TAVI AF trial
Delhi: Findings from the ENVISAGE-TAVI AF trial showed edoxaban to be noninferior to vitamin K antagonists in patients with mainly prevalent atrial fibrillation who underwent successful transcatheter aortic valve replacement (TAVR). The noninferiority was determined by a hazard ratio margin of 38% for a composite primary outcome of adverse clinical events. However, edoxaban was associated with a higher risk of major bleeding than with vitamin K antagonists.
Nicolas M. Van Mieghem and colleagues aimed to determine the role of direct oral anticoagulants as compared with vitamin K antagonists in patients with prevalent or incident atrial fibrillation as the indication for oral anticoagulation after successful TAVR. The study was published in the New England Journal of Medicine on August 28, 2021.
For achieving their objective, the researchers conducted a multicenter, prospective, randomized, open-label, adjudicator-masked trial. The primary efficacy outcome was a composite of adverse events consisting of death from any cause, myocardial infarction, ischemic stroke, systemic thromboembolism, valve thrombosis, or major bleeding. The primary safety outcome was major bleeding.
A total of 1426 patients were enrolled (713 in each group). The mean age of the patients was 82.1 years, and 47.5% of the patients were women.
The study yielded the following findings:
- Almost all the patients had atrial fibrillation before TAVR. The rate of the composite primary efficacy outcome was 17.3 per 100 person-years in the edoxaban group and 16.5 per 100 person-years in the vitamin K antagonist group (hazard ratio, 1.05).
- Rates of major bleeding were 9.7 per 100 person-years and 7.0 per 100 person-years, respectively (hazard ratio, 1.40); the difference between groups was mainly due to more gastrointestinal bleeding with edoxaban.
- Rates of death from any cause or stroke were 10.0 per 100 person-years in the edoxaban group and 11.7 per 100 person-years in the vitamin K antagonist group (hazard ratio, 0.85).
"In patients with mainly prevalent atrial fibrillation who underwent successful TAVR, edoxaban was noninferior to vitamin K antagonists as determined by a hazard ratio margin of 38% for a composite primary outcome of adverse clinical events," wrote the authors. "The incidence of major bleeding was higher with edoxaban than with vitamin K antagonists."
Reference:
The study titled, "Edoxaban versus Vitamin K Antagonist for Atrial Fibrillation after TAVR," is published in the New England Journal of Medicine.
DOI: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2111016
