The outcomes had been introduced on the ESC Congress 2021 from the European Society of Cardiology and concurrently revealed in
“Atrial fibrillation after transcatheter aortic valve replacement is common, especially among older patients, but there has been little research on the optimal treatment strategies, and this has resulted in heterogeneous use of anticoagulants in clinical practice.
TAVR patients are typically very aged and have numerous comorbidities; therefore they are at high risk for all sorts of adverse events, both ischemic and bleeding.
It is important to further understand what treatment is most effective to prevent devastating complications,” says lead investigator George Dangas, MD, PhD, Professor of Medicine (Cardiology) and Director of Cardiovascular Innovation on the Zena and Michael A. Wiener Cardiovascular Institute on the Icahn School of Medicine at Mount Sinai.
“Based on these results, the trial met its primary endpoint of non-inferiority and edoxaban may be a plausible alternative to warfarin, albeit with attention to increased bleeding with this agent in this study population.”
Cardiologists prescribe antithrombotic brokerslike warfarin to stop thromboembolic problems in sufferers who’ve TAVR, a minimally invasive coronary heart process to switch the aortic valve.
Choosing the best antithrombotic routine stays difficult, particularly in sufferers with an underlying situation like AFirregular fast heartbeat that impacts blood circulatethat requires using anticoagulants.
Around 20-40 % of TAVR sufferers have AF and a big proportion of them are frail, so a essential problem in managing their care includes balancing the dangers of bleeding and stroke.
Mount Sinai researchers led a world trial throughout 173 facilities in 14 international locations to check the protection and efficacy of edoxaban versus warfarin in AF sufferers who want oral anticoagulation. To decide efficacy, they checked out mixed opposed medical occasions together with all-cause dying, thromboembolic occasions, and main bleeding. For security they checked out severe bleeding occasions.
Investigators randomized 1,426 sufferers 5 to 12 days after TAVR to both warfarin (with or with out antiplatelet remedy) or 60 mg each day oral edoxaban (with or with out antiplatelet remedy). They adopted up with sufferers for as much as three years following TAVR (common of 18 months).
The research findings confirmed that Edoxaban was noninferior to warfarin for efficacy as assessed by a composite set of ischemic and bleeding opposed occasions. At the identical time, edoxaban led to some greater bleeding problems (primarily gastrointestinal) when in comparison with warfarin (or its analogs as out there in every nation).
Patients who obtained a decrease dose of edoxaban (30 mg as a substitute of 60 mg) because of poor kidney perform or low physique weight appeared to have related charges of opposed thromboembolic and bleeding occasions to these on warfarin.
“The next step would be to establish in large randomized trials the optimal anticoagulant dose according to different bleeding-ischemic risk profiles,” provides Dr. Dangas.
“It seems that lowering the edoxaban dosage when indicated and avoiding patients with mandatory antiplatelet therapy because of their elevated bleeding risk is reasonable safety advice from the clinical point of view.
We will be conducting a detailed analysis on various types of bleeding in the near future. ENVISAGE-TAVI AF suggests that treatment with edoxaban can be valuable in the management of this high-risk population of AF patients after TAVI.”
ENVISAGE-TAVI AF was sponsored by Daiichi Sankyo Inc. with a scientific collaboration between scientists of Icahn Mount Sinai and Global Specialty Medical Affairs of Daiichi Sankyo.