DOAC or VKA for TAVR Patients Requiring Anticoagulation
Quick Takes
- Among patients undergoing TAVR, 36.4% had an indication for long-term anticoagulation therapy.
- Use of direct oral anticoagulant (DOAC) therapy was associated with lower risks of mortality and major bleeding as compared to vitamin K antagonist (VKA) for TAVR patients with an indication for anticoagulation.
- Use of DOAC and VKA anticoagulation had similar rates of ischemic stroke and acute coronary syndrome for TAVR patients with an indication for anticoagulation.
Study Questions:
What are the rates of long-term mortality, bleeding, and ischemic events after TAVR in patients requiring oral anticoagulation (OAC) with either a direct oral anticoagulant (DOAC) or vitamin K antagonist (VKA)?
Methods:
Data from the France-TAVI and FRANCE-2 registries were linked to the French national health single-payer claims database between 2010-2017. Propensity score matching was used to reduce treatment-selection bias. The primary endpoints were death from any cause (efficacy) and major bleeding (safety).
Results:
Among 24,581 patients who underwent TAVR, 8,962 (36.4%) were treated with OAC. Among anticoagulated patients, 2,180 (24.3%) were on DOAC therapy with the remainder using VKA. After propensity matching, 3-year outcomes were higher for mortality (35.6% vs. 31.2%, hazard ratio [HR], 1.37; 95% confidence interval [CI], 1.12-1.67) and major bleeding (12.3% vs. 8.4%, HR, 1.64; 95% CI, 1.17-2.29) for patients treated with VKA versus DOAC. There was no difference in the rate of ischemic stroke (4.8% vs. 3.3%, HR, 1.32; 95% CI, 0.81-2.15) or acute coronary syndrome (4.3% vs. 4.0%, HR, 1.17; 95% CI, 0.68-1.99).
Conclusions:
The authors concluded that long-term mortality and major bleeding were lower among patients treated with DOAC than VKA who underwent TAVR.
Perspective:
Since the publication of the GALILEO trial (Dangas GD, et al., N Engl J Med 2020;382:120-9), clinicians have been concerned about the safety of DOAC therapy in patients who require long-term OAC therapy. In GALILEO, enrolled patients had undergone successful TAVR but did not have an indication for long-term OAC therapy. In contrast, this large French registry included patients who underwent successful TAVR and had an indication for long-term OAC therapy. In such patients, use of DOAC therapy was associated with similar thromboembolic risk and lower bleeding risk as compared to VKA therapy. These data should provide reassurance to clinicians that it is safe to continue DOAC therapy for patients who have an indication for long-term anticoagulation (e.g., atrial fibrillation) and successfully undergo TAVR.
Clinical Topics: Acute Coronary Syndromes, Anticoagulation Management, Arrhythmias and Clinical EP, Cardiac Surgery, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Anticoagulation Management and ACS, Anticoagulation Management and Atrial Fibrillation, Atrial Fibrillation/Supraventricular Arrhythmias, Cardiac Surgery and Arrhythmias, Cardiac Surgery and VHD, Interventions and ACS, Interventions and Structural Heart Disease
Keywords: Acute Coronary Syndrome, Anticoagulants, Atrial Fibrillation, Brain Ischemia, Cardiac Surgical Procedures, Geriatrics, Heart Valve Diseases, Hemorrhage, Stroke, Thromboembolism, Transcatheter Aortic Valve Replacement, Vascular Diseases, Vitamin K
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