Direct Oral Anticoagulants (DOACs) are Non-Inferior to Vitamin K Antagonists for Patients Undergoing Transcatheter Aortic Valve Replacement with Indications of Anticoagulation.

BACKGROUND

The best anticoagulation choice for patients undergoing transcatheter aortic valve replacement (TAVR) with indications of oral anticoagulation (OAC) remains uncertain. We carried out a comprehensive analysis adopting updated evidence that investigated the efficacy and safety of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) in this population.

METHODS

A systematic search has been conducted through PubMed, Embase, and Cochrane Library to collect randomized controlled trials (RCTs) and real-world studies comparing the therapy outcomes of DOACs with VKAs in patients undergoing TAVR with indications of OAC up to Dec 2021. Included studies reported all-cause mortality, bleeding, stroke, or composite endpoint. A random-effects model was used and followed a sensitivity analysis based on the heterogeneity. In addition, five scenario analyses were performed to robust our findings.

RESULTS

Our analysis included 11 articles enrolling a total of 8934 patients undergone TAVR with indications of OAC (DOACs group = 3890, VKAs group = 5044). Pooled analysis revealed no significant different risk of all-cause mortality (aHR: 0.95, 95% CI: 0.65-1.39, : 90.6%), stroke (aHR: 0.86, 95% CI: 0.55-1.35, : 44.3%), bleeding (aHR: 0.83, 95% CI: 0.61-1.13, : 76.3%), and composite endpoint (aHR: 1.05, 95% CI: 0.88-1.24, : 11.7%) in the DOACs and VKAs groups. Various forms of death, stroke and bleeding, including cardiovascular death (aHR: 0.92, 95% CI: 0.64-1.33, : 34.1%), hemorrhagic stroke (aHR: 0.63, 95% CI: 0.23-1.75, : 22.7%), ischemic stroke (aHR: 0.79, 95% CI: 0.56-1.15, : 0.0%), transient ischemic attack (aHR: 0.75, 95% CI: 0.40-1.41, : 0.0%), major or life-threatening bleeding (aHR: 0.96, 95% CI: 0.74-1.24, : 27.9%), and minor bleeding (aHR: 0.90, 95% CI: 0.52-1.57, : 54.3%), also showed similar rates among DOACs and VKAs groups. The results based on five scenarios confirmed the said findings.

CONCLUSIONS

Compared with VKAs, the efficacy and safety of DOACs were comparable for treating TAVR patients combined with anticoagulation indications. Further large-scale RCTs investigating more detailed scenarios are still needed to confirm the optimal anticoagulation strategy.