Post-TAVR oral anticoagulation tied to greater mortality vs. antiplatelet therapy
Direct oral anticoagulation in patients not previously indicated for it who underwent transcatheter aortic valve replacement was associated with increased mortality compared with antiplatelet therapy, researchers reported.
According to a meta-analysis of three randomized controlled trials published in Circulation: Cardiovascular Interventions, the mortality risk conferred by post-TAVR direct oral anticoagulants (DOACs) was driven by bleeding events. However, DOAC was associated with lower risk for leaflet thickening and restricted leaflet motion compared with antiplatelet therapy.
“We demonstrated that, compared with antiplatelet therapy, DOACs were associated with higher risk of all-cause mortality and noncardiac mortality, which seemed to be driven by a numerical higher number of major/life-threatening bleeding events,” Ayman Elbadawi, MD, advanced training fellow of structural interventional cardiology at the University of Texas Southwestern Medical Center, and colleagues wrote. “DOACs were not associated with a reduction in the risk of clinical thromboembolic events and cerebrovascular accident, but DOACs were associated with reduced risk for leaflet thickening and reduced motion. Importantly, there was minimal heterogeneity for all study outcomes.”
Elbadawi and colleagues conduced a meta-analysis of the ADAPT-TAVR, ATLANTIS and GALILEO studies, including 2,922 participants without an indication for post-TAVR chronic oral anticoagulation, to evaluate the efficacy and safety of post-TAVR oral anticoagulation compared with antiplatelet therapy. For valve leaflet data, the researchers used the ATLANTIS 4D-CT and GALILEO imaging substudies.
Compared with antiplatelet therapy, researchers reported that post-TAVR DOAC use in patients not previously indicated for anticoagulation was associated with higher incidence of all-cause mortality (6.7% vs. 4%; RR = 1.68; 95% CI, 1.22-2.30; I2 = 0%) and noncardiac mortality (2.9% vs. 1.2%; RR = 2.33; 95% CI' 1.13-4.8; P = .02).
In addition, there was a trend toward higher incidence of cardiac mortality with DOACs compared with antiplatelet therapy (3.8% vs. 2.7%; RR = 1.33; 95% CI, 0.89-1.99; P = .16). There was also a trend toward elevated risk for major bleeding in the DOAC group (6.4% vs. 5%; RR = 1.26; 95% CI, 0.94-1.7; P = .12), and there was no significant difference in all bleeding events, acute cerebrovascular accident and systemic thromboembolic events, the researchers wrote.
Moreover, DOACs compared with antiplatelet therapy were associated with lower incidence of hypoattenuated leaflet thickening (9.1% vs. 18.3%; RR = 0.5; 95% CI, 0.36-0.7) and restricted leaflet motion (1.7% vs. 8.6%; RR = 0.21; 95% CI, 0.1-0.44).
“Collectively, these findings support the notion that hypoattenuated leaflet thickening and restricted leaflet motion may not carry significant clinical implications in short-term outcomes after TAVR, but rather represent subclinical advanced-imaging phenomena,” the researchers wrote. “It would be of interest to identify subgroups of patients with a favorable risk/benefit profile with DOACs who could possibly attain the prevention of leaflet thrombosis without excess bleeding harm. However, the lack of patient-level data in the current analysis prevented such granular assessment.”
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