The enthusiasm for direct oral anticoagulants after transcatheter aortic valve replacements (TAVR) is waning. At least, when it combines with atrial fibrillation. The ENVISAGE-TAVI AF has shown excessive bleeding with endoxaban vs. the classical vitamin K antagonists.
Endoxaban resulted non-inferior to vitamin K antagonists in terms of net clinical adverse events, but major bleeding events rate resulted much higher with the new anticoagulant (9.7 vs 7 patients/year).
At these rates, the drug does not achieve non-inferiority. The difference was driven by more gastrointestinal bleeding with endoxaban (one was fatal). Intracranial bleeding resulted low and similar in both groups.
An exploratory analysis of this study suggests the risk/benefit ratio of endoxaban is better in patients who meet the criteria to receive half the dose and have not been receiving dual antiaggregation therapy.
The list of drawbacks had already started with the ATLANTIS, presented at ACC 2021.
Though the cohort B of the POPular TAVI had shown that, when anticoagulation is indicated, direct antagonists are the best option, as long as they do not combine with antiplatelet antiaggregation.
The present ENVISAGE-TAVI AF included 1426 patients from 173 centers in 14 countries successfully undergoing TAVR who had also been prescribed chronic anticoagulation for atrial fibrillation.
Read also: ESC 2021 | COVERT-MI: Colchicine Attempts to Reduce Infarct Size.
1,426 TAVR patients with atrial fibrillation (mean age 82.1 years, 47% women) were randomized to 60 mg/day of endoxaban vs vitamin K antagonists. Those with creatinine clearance between 15 and 50 ml or weighing less than 60 kg received half the dose. Almost half of the enrolled patients met one of these criteria and received only 30 mg/day.
Despite the net clinical benefit did reach non-inferiority, major bleeding rate with endoxaban resulted 40% higher.
Ischemic events such as strokes, all cause cardiac death or MI resulted identical and there were no valve thrombosis cases in the cohort.
ENVISAGE-TAVI AFOriginal Title: Edoxaban versus Vitamin K Antagonist for Atrial Fibrillation after TAVR.
Reference: N.M. Van Mieghem presentado en ESC 2021 y publicado simultáneamente en NEJM.
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