The widespread growth of TAVR has created pressure to continually improve both short-term and long-term outcomes. Historically, studies have shown women to have a higher post-TAVR survival rate than men, but an increased risk of early bleeding. However, recent research presented at the Society for Cardiovascular Angiography and Interventions (SCAI) conference suggests that short-term outcomes are equalizing.
Lead author Dr. Anita Asgar from the Montreal Heart Institute presented results of the BRAVO 3 trial at SCAI 2016 in Orlando. The trial randomized 802 high-risk, transfemoral access TAVR patients across 31 centers in North America and Europe to one of two anticoagulation strategies: bivalirudin or unfractioned heparin. 391 women and 411 men were randomized, with a primary endpoint of major bleeding within 24 hours post-procedure. The goal was to assess whether a specific anticoagulation strategy could decrease bleeding risk in women. The results showed similar 30-day outcomes for men and women:
Rates of major bleeding at 48 hours were 10.5% in men and 9.0% in women. There was also a trend towards decreased mortality in women given bivalirudin as opposed to unfractioned heparin, although not statistically significant.
Importantly, the study only looked at outcomes up to 30-days, and other findings presented at SCAI 2016 suggest that long-term TAVR outcomes continue to differ substantially between men and women. Dr. Asgar highlights the need for longer-term research, hoping that her study will serve as a catalyst for more in-depth, longitudinal analyses of sex-based outcome improvement for TAVR patients.