Novel oral anticoagulants versus vitamin K antagonists in patients with atrial fibrillation after transcatheter aortic valve replacement: A systematic review and meta‐analysis

Abstract

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.

Efficacy and Safety of NOACs Compared With VKAs for Patients With Atrial Fibrillation After Transcatheter Aortic Valve Implantation: A System Review and Meta-Analysis

“…33 Another meta-analysis conducted by Memon et al showed no significant difference in stroke or systemic embolism, all-cause mortality, major bleeding, intracranial hemorrhage, and myocardial infarction between NOACs versus VKAs for AF patients undergoing TAVI. 32 Our metaanalysis revealed that the patients prescribed NOACs had a lower incidence of bleeding and intracranial bleeding. However, sensitivity analyses found that the effects of NOACs and VKAs were equivalent in bleeding and intracranial bleeding after the exclusion of Tanawuttiwat et al study.…”

“…The largest observational study by Tanawuttiwat et al was not included in prior meta-analysis. 32 Interestingly, the patients prescribed NOACs tended to have a lower incidence of all-cause mortality with the RRs less than 1 despite no statistical difference. Qualitative analysis showed that the three studies might be the source of the large heterogeneity of all-cause mortality, yet meta-regression did not find the specific factors leading to heterogeneity.…”

“…To date, the latest guidelines do not specify the preference of NOACs or VKAs for anticoagulant therapy in AF patients after TAVI. 1 Although the meta-analyses on the clinical outcomes of NOACs versus VKAs after TAVI in patients with AF have been published, 32,33 the search was more comprehensive with an increase in the number of patients enrolled and only studies with AF patients accounting for more than 90% of all TAVI patients were included in our meta-analysis. Most importantly, the results of our meta-analysis differed from those metaanalyses.…”

Bioprosthetic Aortic Valve Thrombosis: Definitions, Clinical Impact, and Management: A State-of-the-Art Review

“…83 A subsequent meta-analysis comparing NOACs to warfarin after TAVR in patients with atrial fibrillation found no significant difference in stroke or systemic embolism, major bleeding, or all-cause mortality. 84…”