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About half of patients undergoing transfemoral aortic valve implantation (TAVI) suffer from atrial fibrillation. Non-vitamin K antagonist oral anticoagulants have not been systematically used in patients after TAVI with atrial fibrillation.
We enrolled 617 patients undergoing transfemoral aortic valve replacement. 55.9% (N=345) were in sinus rhythms (SR) and 44.1% (N=272) in atrial fibrillation (AF). Follow-up was 12 months. AF patients were significantly older, presenting with more comorbidities.
Early safety endpoint at 30 days was significantly higher in AF, with 23.2% versus 11.0% in SR (p<0.01) with a significantly higher rate of life-threatening bleedings. During late follow-up (12 months) the secondary endpoint was significantly higher in AF patients (20.6% vs. 9.7%, p=0.02) driven by a significantly higher rate of all-cause mortality (19.1% vs. 7.8%, p=0.01). There was no difference in stroke rate. In AF, 141 (51.8%) patients were on oral anticoagulation with apixaban and 131 (48.2%) with a vitamin k antagonist (VKA). Early safety endpoint with apixaban was significantly lower (13.5% vs. 30.5%, p<0.01), driven by a lower rate of acute kidney injuries and life threatening bleedings (3.5% vs. 5.3%, p<0.01), with a lower stroke rate of 2.1% compared with 5.3% on a VKA (p=0.17). The secondary endpoint was similar between groups at 30 days and long-term follow-up within 12 months (2.1% vs. 3.8%, p=0.42), with no major bleeding in neither group. There was a persisting tendency to a lower stroke rate on apixaban.
Apixaban is safe and effective in the prevention of thromboembolic events in atrial fibrillation patients undergoing TAVI.
STRUCTURAL: Valvular Disease: Aortic