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Edoxaban (Savaysa) has been shown to be non-inferior to vitamin K antagonist (warfarin) therapy for the treatment of atrial fibrillation in patients who have successfully undergone aortic valve replacement catheter (TAVR) ), according to new findings presented to the European Society of Cardiology (ESC). ) Congress 2021 this weekend.
Researchers in the ENVISAGE-TAVI AF trial confirmed that the direct oral anticoagulant (DOA), previously approved for the prevention of stroke and non-CNS systemic embolism, offered a non-inferior benefit for prevention composite of adverse events to the standard care vitamin K antagonist in the observed patient. population.
About a third of all patients scheduled for TAVR have atrial fibrillation, the researchers explained, with oral anticoagulants without vitamin K being the primary method of treatment.
“The effects of various antithrombotic strategies to prevent thromboembolic events with atrial fibrillation after TAVR have not been well studied,” they wrote. “An exploratory subgroup analysis involving 191 patients with previous bioprosthetic valve implantation, the results of which are reported in a separate article, suggested that clinical outcomes may have been better with edoxaban than with warfarin. . “
The multicenter, prospective, randomized, open-label, masked adjudicator evaluation compared edoxaban to the competitor class of drugs in patients with prevalent or incident atrial fibrillation.
Led by George Dangas, MD, PhD, professor of medicine at Icahn School of Medicine at Mount Sinai, the researchers sought a primary endpoint of the efficacy of composite adverse events associated with post-TAVR atrial fibrillation, notably :
- Death from any cause
- Myocardial infarction
- Ischemic stroke
- Systemic thromboembolism
- Valve thrombosis
- Major bleeding
The ENVISAGE-TAVI AF team also looked for a primary endpoint of the safety of major bleeding. Efficacy and safety results were tested sequentially for non-inferiority; the non-inferiority of edoxaban has been established within the upper limit of the 95% confidence interval for a relative risk (HR) of composite events not exceeding 1.38.
Through hierarchical testing, superiority testing for DOAC treatment over vitamin K antagonist would be performed if edoxaban achieved non-inferiority and superiority for the risk of major bleeding.
The trial population included 1426 patients enrolled 1: 1 with edoxaban (n = 713) or vitamin K antagonist (n = 713). The mean age of the patients was 82.1 years, with 47.5% of the population being women. Atrial fibrillation was prevalent in most patients before the TAVR procedure.
Dangas and colleagues observed the composite primary efficacy result 17.3 times per 100 person-years in patients treated with edoxaban, compared with 16.5 timers per 100 person-years in patients treated with a vitamin K antagonist. , indicating an RR of 1.05 (95% CI, 0.85 – 1.31; P = .01) and showing the non-inferiority of the DOAC.
The major bleeding rates were 9.7 per 100 person-years and 7.0 per 100 person-years in the 2 groups, respectively, indicating an RR of 1.40 (95% CI, 1.03 – 1 , 91; P = .93). Edoxaban did not achieve non-inferiority in the primary endpoint of safety, primarily due to the significant increase in the rate of gastrointestinal bleeding in patients treated with edoxaban.
Deaths from all causes or the prevalence of stroke were 10.0 per 100 person-years in patients treated with edoxaban and 11.7 per 100 person-years in patients treated with a vitamin K antagonist, showing the potential superiority of edoxaban in the 2 outcomes (RR: 0.85; 95% CI, 0.66 – 1.11).
Dangas and colleagues concluded that edoxaban was non-inferior to the vitamin K antagonist in reducing composite adverse clinical events in post-TAVR patients with atrial fibrillation. However, the incidence of major bleeding was observed to be higher with treatment with DOAC.
“Due to the hierarchical design of our statistical analysis, the inability to show non-inferiority for major bleeding precluded formal superiority testing of edoxaban, but the point estimate of the risk ratio favored antagonists of edoxaban. vitamin K and the confidence interval included 1, indicating that the superiority of edoxaban would not have been shown, ”they wrote.
The study, “Edoxaban versus Vitamin K Antagonist for Atrial Fibrillation after TAVR”, has been published online in The New England Journal of Medicine.
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