Key result
DOACs linked to ~68% higher all-cause mortality vs standard of care after TAVR.
Why the study?
The optimal antithrombotic therapy in patients without indications for an oral anticoagulant after TAVR has yet to be identified.
Does DOAC treatment improve clinical outcomes compared to standard of care in patients without an indication for anticoagulation after TAVR?
Meta-Analysis (n=2,922)
Does DOAC treatment improve clinical outcomes compared to standard of care in patients without an indication for anticoagulation after TAVR?
Relative Risk: 1.68 (95% CI 1.22–2.3)
p-value: p=0.001
In patients without an indication for oral anticoagulation after TAVR, routine use of DOACs is associated with increased all-cause mortality and adverse clinical events despite reducing subclinical leaflet thrombosis.
DOACs raise mortality and ischemic risks after TAVR without OAC indication; challenges routine use and supports antiplatelet standard in RCTs.
Transcatheter aortic valve replacement (TAVR) is now considered the mainstay of aortic stenosis management; however, the optimal antithrombotic therapy in patent without indications for an oral anticoagulant (OAC) is yet to be identified. Therefore, we conducted a systematic review and meta-analysis to evaluate the efficacy and safety of direct oral anticoagulant (DOAC) treatment versus the standard of care in patients without indications of OACs after TAVR. We synthesized randomized controlled trials (RCTs) from Web of Science, SCOPUS, EMBASE, PubMed, and Cochrane until 18 August 2022. We used the risk ratio (RR) for dichotomous outcomes with the corresponding 95% confidence interval (CI). We registered our protocol in PROSPERO with ID: CRD42022357027. Three RCTs with 2922 patients were identified. DOACs were significantly associated with higher incidence of all-cause mortality (RR: 1.68 with 95% CI [1.22, 2.30], p = 0.001), mortality due to non-cardiovascular causes (RR: 2.34 with 95% CI [1.36, 4.02], p = 0.002), and the composite outcome of death, myocardial infarction, or stroke (RR: 1.41 with 95% CI [1.13, 1.76], p = 0.002). However, DOACs were associated with decreased incidence of reduced leaflet motion (RLM) (RR: 0.19 with 95% CI [0.09, 0.41], p = 0.0001) and hypoattenuated leaflet thickening (HALT) (RR: 0.50 with 95% CI [0.36, 0.70], p = 0.0001). DOACs were effective to reduce RLM and HALT; however, the clinical effect of this is still controversial. DOACs were associated with worse efficacy and safety outcomes, including all-cause mortality. Further RCTs investigating the optimal antithrombotic regimen after TAVR.
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Abuelazm et al. (2022) conducted a meta-analysis in Aortic stenosis post-transcatheter aortic valve replacement (TAVR) without indication for oral anticoagulants (n=2,922). Direct oral anticoagulants (DOACs) vs. Standard of care was evaluated on All-cause mortality (RR 1.68, 95% CI 1.22, 2.30, p=0.001). Direct oral anticoagulants were associated with a higher incidence of all-cause mortality compared to standard of care after TAVR (RR 1.68; 95% CI 1.22-2.30; p=0.001).
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