Efficacy and safety of novel oral anticoagulants in patients with bioprosthetic valves.

PURPOSE: Prosthetic valve replacement is performed in several hundred thousand patients worldwide annually, and many of these patients have or will ultimately develop atrial fibrillation or flutter (AF). Novel oral anticoagulants (NOACs) are not recommended in patients with AF and mechanical valves but have not been evaluated in patients with bioprosthetic valves. This study sought to evaluate the efficacy and safety of NOACs in patients with AF and bioprosthetic valves.

METHODS: A retrospective single-center cohort study was performed on all patients with bioprosthetic valve implantation, for whom a NOAC was prescribed for the indication of AF. Patients were evaluated for thromboembolic events including imaging confirmed ischemic stroke, clinically suspected transient ischemic attack, and major bleeding events (according to International Society on Thrombosis and Hemostasis definition).

RESULTS: In total, 73 patients (26 female, 35.6 %) were identified. NOAC therapy began, on average, 990.0 ± 1029.1 days after bioprosthetic valve implantation for an average duration of 511.8 ± 400.8 days. Aspirin was used concomitantly in a majority of patients (72.6 %). There were no ischemic strokes identified (0.0 %) and one possible TIA (1.4 %). There were 6 (8.2 %) minor and 5 (6.9 %) major bleeding events.

CONCLUSION: The use of NOAC therapy for AF in patients with bioprosthetic valves appears safe and effective in the occurrence of thromboembolic events, however, at the expense of increased bleeding. Larger studies are necessary to confirm these findings.