When Direct Oral Anticoagulants Should Not Be Standard Treatment
Antoine BejjaniCandrika D. KhairaniAli AssiGregory PiazzaParham SadeghipourAzita H. TalasazJohn FanikosJean M. ConnorsDeborah SiegalGeoffrey D. BarnesKarlyn A. MartinDominick J. AngiolilloDawn KleindorferManuel MonréalDavid JiménezSaskia MiddeldorpMitchell S.V. ElkindChristian T. RuffSamuel Z. GoldhaberHarlan M. KrumholzRoxana MehranMary CushmanJohn W. EikelboomGregory Y.H. LipJeffrey I. WeitzRenato D. LópesBehnood Bikdeli
Key result
DOACs appear inferior to standard care for mechanical valves, thrombotic antiphospholipid syndrome, and rheumatic AF.
Journal of the American College of Cardiology published a graphical abstract
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Why the study?
DOACs are preferred for many indications, but their efficacy and safety remain suboptimal or uncertain across several specific cardiovascular and thromboembolic conditions.
In which clinical conditions do direct oral anticoagulants lack efficacy or safety compared to standard of care?
Key Points
- To synthesize randomized controlled trial evidence regarding specific clinical settings where direct oral anticoagulants should not be standard treatment or where their clinical efficacy remains uncertain.
- Evidence-based review synthesizing randomized controlled trials evaluating direct oral anticoagulants against standard-of-care therapies (such as vitamin K antagonists) across various thromboembolic and cardiovascular conditions.
- Study show direct oral anticoagulants are inferior in safety or efficacy compared to standard of care for mechanical heart valves, thrombotic antiphospholipid syndrome, and atrial fibrillation with rheumatic heart disease.
- Direct oral anticoagulants provide no net clinical benefit in embolic stroke of undetermined source.
- Evidence remains inconclusive regarding direct oral anticoagulant efficacy and safety for left ventricular thrombus, catheter-associated deep vein thrombosis, cerebral venous sinus thrombosis, and end-stage renal disease.
Structured PICO
In which clinical conditions do direct oral anticoagulants lack efficacy or safety compared to standard of care?
P
Population
Patients with mechanical heart valves, thrombotic antiphospholipid syndrome, atrial fibrillation associated with rheumatic heart disease, embolic stroke of undetermined source, left ventricular thrombus, catheter-associated deep vein thrombosis, cerebral venous sinus thrombosis, or end-stage renal disease
I
Intervention
Direct oral anticoagulants (DOACs)
C
Comparator
Current standard of care (e.g., vitamin K antagonists)
O
Outcome
Efficacy and safety (stroke prevention and venous thromboembolism treatment)
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“There's a large portion of people either with A-fib who require anticoagulation or with VTE, and potentially even for some other indication, who would truly benefit from DOACs, because in many scenarios, they're at least as effective and not infrequently they are safer. Without question, they're more convenient for patients and for clinicians. So there's a lot of good that they do, but that doesn't mean that they get carte blanche for every single condition, every single indication.”
“The results we reviewed here have significant implications for optimizing anticoagulation therapy and improving patient outcomes in clinical practice. There is a critical need for further research regarding why DOACs are less efficacious or safe than the standard of care in certain scenarios.”
“It's from a large group of real experts in this field, and I think it adds quite a lot to our understanding and our practical management of patients.”
Implication
While DOACs are preferred for most patients, they should not be standard treatment for mechanical heart valves, thrombotic antiphospholipid syndrome, rheumatic atrial fibrillation, and embolic stroke of undetermined source.
Abstract
For most patients, direct oral anticoagulants (DOACs) are preferred over vitamin K antagonists for stroke prevention in atrial fibrillation and for venous thromboembolism treatment. However, randomized controlled trials suggest that DOACs may not be as efficacious or as safe as the current standard of care in conditions such as mechanical heart valves, thrombotic antiphospholipid syndrome, and atrial fibrillation associated with rheumatic heart disease. DOACs do not provide a net benefit in conditions such as embolic stroke of undetermined source. Their efficacy is uncertain for conditions such as left ventricular thrombus, catheter-associated deep vein thrombosis, cerebral venous sinus thrombosis, and for patients with atrial fibrillation or venous thrombosis who have end-stage renal disease. This paper provides an evidence-based review of randomized controlled trials on DOACs, detailing when they have demonstrated efficacy and safety, when DOACs should not be the standard of care, where their safety and efficacy are uncertain, and areas requiring further research.
Discussion
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Cite This Study
Bejjani et al. (2024) conducted a review in Conditions requiring anticoagulation. Direct oral anticoagulants (DOACs) vs. Vitamin K antagonists or standard of care was evaluated. Direct oral anticoagulants may not be as efficacious or safe as standard care for mechanical heart valves, thrombotic antiphospholipid syndrome, and rheumatic atrial fibrillation.