Effect of valve design and anticoagulation strategy on 30-day clinical outcomes in transcatheter aortic valve replacement: Results from the BRAVO 3 randomized trial

Background: Selection of valve and procedural anticoagulant type may impact bleeding and vascular complications in transfemoral transcatheter aortic valve replacement (TAVR). We sought to compare outcomes by valve [balloon expandable (BE) or non-BE] and anticoagulant [bivalirudin vs. unfractionated heparin (UFH)] type from the BRAVO-3 trial. Methods: BRAVO-3 was a randomized multicenter trial included 500 BE-TAVR and 282 non-BE TAVR patients, randomized to bivalirudin vs. UFH. Selection of valve type was at the discretion of the operator and randomization was stratified according to device type. Total follow up was to 30 days. We examined the incidence of Bleeding Academic Research Consortium (BARC) type ≥3b bleeding, major vascular complications and all ischemic outcomes at 30-days. Outcomes were adjusted using logistic regression analysis. Results: Of the trial cohort treated, 63.9% were treated with BE valves (n=251 bivalirudin vs. n=249 UFH) and 36.1% with non-BE valves (n=140 bivalirudin vs. n=142 UFH). Patients treated with non-BE valves were older, with higher euroSCORE I. At 30 days, there were non-significant differences between the two valve types with a trend for higher adjusted risk of all-cause mortality (HR 2.07, 95% CI 0.91-4.70, p = 0.084) and major vascular complications (HR 1.78, 95% CI 0.97-3.26, p = 0.062) with non-BE compared to BE valves. A significant interaction was observed between valve and anticoagulant type, with lower risk of major vascular complications with bivalirudin compared to UFH in non-BE TAVR (p-interaction = 0.039). Conclusions: Majority of patients in the BRAVO 3 trial received BE valves. At 30-days, there were non-significant differences with a tendency for greater death and major vascular complications with non-BE vs. BE valves. A significant interaction was observed between valve type and procedural anticoagulant for lower risk of major vascular complications with bivalirudin versus UFH in non-BE TAVR. This article is protected by copyright. All rights reserved.