Background: Antithrombotic recommendations following transcatheter aortic valve replacement (TAVR) are largely based on previous trial protocols. The efficacy and risk of anticoagulation has not been systematically assessed. The aim of this study was to determine the efficacy and safety of oral anticoagulation in patients with atrial fibrillation (AF) following TAVR with the Lotus Valve System (Boston Scientific, Marlborough, MA, USA). Methods: Consecutive patients with severe aortic stenosis who underwent Lotus valve implantation were prospectively recruited (n = 164). Atrial fibrillation patients prescribed oral anticoagulation (standard AF therapy) were compared to non-AF patients prescribed aspirin and clopidogrel (standard non-AF therapy). Twenty (20) of 164 patients were excluded, as they were not prescribed standard therapy. The primary endpoint was 6-month incidence of death, myocardial infarction, stroke/transient ischaemic attack (TIA) or major/life-threatening bleeding. Secondary endpoints included each component of the primary endpoint, defined according to VARC-2. Results: Overall, the primary endpoint occurred in 20.8% and 17.7% of the standard AF and standard non-AF therapy groups respectively (p = 0.82). There was no statistically significant difference in bleeding (12.5% versus 9.4%, p = 0.77) or stroke/TIA (2.1% versus 8.3%, p = 0.27) between the standard AF and standard non-AF therapy groups respectively. Conclusions: This study supports the safety of anticoagulation in AF patients, which did not result in excess risk of bleeding or stroke/TIA compared with dual antiplatelet therapy in non-AF patients.
- Transcatheter aortic valve replacement