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Background: 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 TAVI patients with atrial fibrillation. Renal insufficiency is a well-known risk factor.
Methods: 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.
Results: 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). Chronic renal failure was present in 44.7% in the apixaban and 48.9% in the VKA group. 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 (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 in patients on apixaban. In a subgroup analyses of patients with impairment of renal function and a creatinine clearance >15 ml/min, results were consistent with a significantly lower early safety endpoint (28.5% vs. 13.5%, p<0.01) and lower rate of acute kidney injury (5.7% vs. 2.1%, p<0.01).
Conclusions: In TAVI patients the presence of atrial fibrillation was associated with significantly higher rates of all-cause mortality throughout 12 months follow-up. The early safety endpoint in atrial fibrillation patients on apixaban was significantly lower compared with a VKA, also in the subgroup of patients with renal insufficiency.
Poster Hall, Hall C
Saturday, March 18, 2017, 3:45 p.m.-4:30 p.m.
Session Title: Interventional Cardiology: TAVR 3
Abstract Category: 17. Interventional Cardiology: Aortic Valve Disease
Presentation Number: 1243-182
- 2017 American College of Cardiology Foundation