Why the study?
The efficacy and safety of NOACs compared to guideline-recommended VKAs in patients with AF undergoing TAVR had not been well established.
Do NOACs reduce stroke, bleeding, or mortality compared to VKAs in patients with atrial fibrillation undergoing TAVR?
Do NOACs reduce stroke, bleeding, or mortality compared to VKAs in patients with atrial fibrillation undergoing TAVR?
In patients with atrial fibrillation undergoing TAVR, NOACs have comparable efficacy and safety to VKAs, with no significant differences in stroke, bleeding, or mortality.
NOACs yield similar outcomes to VKAs in AF patients after TAVR; extends pooled evidence without establishing superiority.
BACKGROUND: The efficacy and safety of novel oral anticoagulants (NOACs) compared to the current guideline-recommended vitamin K antagonists (VKAs) in atrial fibrillation (AF) patients undergoing transcatheter aortic valve replacement (TAVR) has not been well established. We pooled evidence from all available studies to assess the risks and benefits of this drug class. METHODS: We queried electronic databases (MEDLINE, Scopus, and Cochrane central) up until January 28th, 2022 for studies comparing NOACs to VKAs in AF patients undergoing TAVR. Results from studies were presented as risk ratios (RR) and pooled using a random-effects model. Subgroup analysis by study design and meta-regression analysis were performed to explore heterogeneity. RESULTS: A total of 12 studies (3 RCTs and 9 observational) containing 12,203 patients (mean age 81.2 years; 50.5% men) were identified and included in the analysis. Pooled analysis revealed no significant difference between NOACs and VKAs in terms of stroke or systemic embolism (RR: 0.78; p = 0.18), major bleeding (RR: 0.84; p = 0.32), intracranial hemorrhage (RR 0.61; p = 0.06), all-cause mortality (RR: 0.69; p = 0.07), and myocardial infarction (RR: 1.60; p = 0.24) at a mean length of follow-up of 15.1 months. RCTs and observational studies did not significantly differ across outcomes on subgroup analysis. Meta-regression analysis found heterogeneity in all-cause mortality to be significantly explained by percentage of males (coefficient: 0.049, p = 0.007), mean age (coefficient: 0.221, p < 0.001), and CHA2DS2-VASc score (coefficient: -1.657, p < 0.001). CONCLUSIONS: This meta-analysis suggests that outcomes with NOACs do not significantly differ compared to VKAs following TAVR in patients with AF.
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Memon et al. (2022) studied this question.
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