Edoxaban may be effective treatment for atrial fibrillation after transcatheter aortic valve replacement

Date:
August 29, 2021
Source:
The Mount Sinai Hospital / Mount Sinai School of Medicine
Summary:
A new study compares edoxaban anticoagulant with the standard of
care in large randomized clinical trial.



FULL STORY ==========================================================================
The anticoagulant edoxaban may be just as effective as warfarin for
preventing heart attack or stroke in patients with atrial fibrillation
(AF) who undergo transcatheter aortic valve replacement (TAVR), according
to a large-scale international study led by Mount Sinai.


==========================================================================
The ENVISAGE-TAVI AF trial is the largest to investigate an edoxaban-based strategy in this patient population compared with warfarin, which
is currently the standard of care. It demonstrates that edoxaban
is non-inferior to warfarin. The results, which could lead to an
alternative treatment strategy, were announced Saturday, August 28,
as a late-breaking clinical trial at the ESC Congress 2021 from the
European Society of Cardiology and simultaneously published in The New
England Journal of Medicine.

"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 elderly and possess 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 at the Zena and Michael A. Wiener Cardiovascular Institute at 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 agents -- specifically warfarin,
a vitamin K antagonist -- to prevent thromboembolic complications in
patients who have TAVR, a minimally invasive heart procedure to replace
the aortic valve.

Choosing the optimal antithrombotic regimen remains challenging,
especially in patients with an underlying condition like AF -- irregular
rapid heartbeat that impacts blood flow -- that requires the use of anticoagulants. Past studies have shown anywhere between 20-40 percent
of TAVR patients have AF and a large proportion of them are frail, so
a main challenge in managing their care involves balancing the risks of bleeding and stroke.

Until now, there has been minimal research into the optimal oral anticoagulation therapy in TAVR patients.

Mount Sinai researchers led an international trial across 173 centers
in 14 countries to compare the safety and efficacy of edoxaban versus
warfarin in AF patients who need oral anticoagulation. To determine
efficacy, they looked at combined adverse clinical events including
all-cause death, thromboembolic events, and major bleeding. For safety
they looked at serious bleeding events.

Investigators randomized 1,426 patients 5 to 12 days after TAVR to
either warfarin (with or without antiplatelet therapy) or 60 mg daily
oral edoxaban (with or without antiplatelet therapy). They followed
up with patients for up to three years following TAVR (average of 18
months). The study findings showed that edoxaban was noninferior to
warfarin for efficacy as assessed by a composite set of ischemic and
bleeding adverse events. At the same time, edoxaban led to some higher
bleeding complications (mainly gastrointestinal) when compared to warfarin
(or its analogs as available in each country).

Interestingly, patients who received a lower dose of edoxaban (30 mg
instead of 60 mg) due to poor kidney function or low body weight appeared
to have similar rates of adverse thromboembolic and bleeding events to
those on warfarin.

"The next step would be to establish in large randomized trials the
optimal anticoagulant dose according to different bleeding-ischemic risk profiles," adds 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.

========================================================================== Story Source: Materials provided by The_Mount_Sinai_Hospital_/_Mount_Sinai_School_of Medicine. Note: Content
may be edited for style and length.


========================================================================== Journal Reference:
1. Nicolas M. Van Mieghem, Martin Unverdorben, Christian Hengstenberg,
Helge
Mo"llmann, Roxana Mehran, Diego Lo'pez-Otero, Luis Nombela-Franco,
Raul Moreno, Peter Nordbeck, Holger Thiele, Irene Lang, Jose'
L. Zamorano, Fayaz Shawl, Masanori Yamamoto, Yusuke Watanabe,
Kentaro Hayashida, Rainer Hambrecht, Felix Meincke, Pascal
Vranckx, James Jin, Eric Boersma, Josep Rode's-Cabau, Patrick
Ohlmann, Piera Capranzano, Hyo-Soo Kim, Thomas Pilgrim, Richard
Anderson, Usman Baber, Anil Duggal, Petra Laeis, Hans Lanz,
Cathy Chen, Marco Valgimigli, Roland Veltkamp, Shigeru Saito,
George D. Dangas. Edoxaban versus Vitamin K Antagonist for Atrial
Fibrillation after TAVR. New England Journal of Medicine, 2021;
DOI: 10.1056/NEJMoa2111016 ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2021/08/210829081922.htm

--- up 16 weeks, 2 days, 22 hours, 45 minutes
* Origin: -=> Castle Rock BBS <=- Now Husky HPT Powered! (1:317/3)