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

## TL;DR

Direct oral anticoagulants are as effective and safe as vitamin K antagonists for patients needing anticoagulation after aortic valve replacement.

## Contribution

This study provides updated evidence comparing DOACs and VKAs in TAVR patients with anticoagulation needs.

## Key findings

- DOACs showed no significant difference in all-cause mortality, stroke, or bleeding compared to VKAs.
- Similar rates of cardiovascular death, hemorrhagic and ischemic stroke, and major bleeding were observed between DOACs and VKAs.
- Five scenario analyses confirmed the consistent results across different conditions.

## Abstract

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.

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.

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, I2: 90.6%), stroke (aHR: 0.86, 95% CI: 0.55–1.35,
I2: 44.3%), bleeding (aHR: 0.83, 95% CI: 0.61–1.13,
I2: 76.3%), and composite endpoint (aHR: 1.05, 95% CI:
0.88–1.24, I2: 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, I2: 34.1%), hemorrhagic stroke (aHR: 0.63, 95% CI:
0.23–1.75, I2: 22.7%), ischemic stroke (aHR: 0.79, 95% CI:
0.56–1.15, I2: 0.0%), transient ischemic attack (aHR: 0.75, 95% CI: 0.40–1.41, I2: 0.0%), major or life-threatening bleeding
(aHR: 0.96, 95% CI: 0.74–1.24, I2: 27.9%), and minor bleeding
(aHR: 0.90, 95% CI: 0.52–1.57, I2: 54.3%), also showed similar
rates among DOACs and VKAs groups. The results based on five scenarios confirmed
the said findings.

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.