BRAVO 3 Compares Two Anticoagulants for Gender-Based TAVR Outcomes

May 9, 2016—Findings from the BRAVO 3 study—which assessed the impact of using different anticoagulation medications on men and women who have undergone transcatheter aortic valve replacement (TAVR)—found no difference in early vascular complications or mortality. 

The BRAVO 3 results were presented as a late-breaking clinical trial at the Society for Cardiovascular Angiography and Interventions (SCAI) 2016 Scientific Sessions in Orlando, Florida last week. Additionally, the study by Anita W. Asgar, MD, et al, was accepted for publication and is available online in Catheterization and Cardiovascular Interventions.

According to SCAI, the study evaluated contemporary transfemoral TAVR procedures and compared the use of two anticoagulation medications, bivalirudin and unfractionated heparin (UFH). The study was a randomized multicenter trial with 31 centers participating (N = 802). The primary endpoint was major bleeding occurring within 48 hours. Major bleeding was defined as Bleeding Academic Research Consortium type 3b, which is overt bleeding with a significant drop in hemoglobin or that requires surgical intervention and/or intravenous vasoactive agents to control.

SCAI summarized the BRAVO 3 study, which was composed of 49% women (n = 391; 195 received bivalirudin and 196 received UFH) and 51% men (n = 411; 209 received bivalirudin and 202 received UFH). Women were older than men and had fewer comorbidities, such as coronary artery disease, atrial fibrillation, and diabetes. Women had a lower EuroSCORE I, but all patients were considered high-risk for TAVR.

The investigators found that at 30 days, men and women demonstrated similar survival (19 men vs 19 women; P = .87), major adverse cardiac events (34 men vs 29 women; P = .65), and vascular complications (32 men vs 43 women; P = .12).

BRAVO 3 did find a trend (not statistically significant) that women who were given bivalirudin experienced less mortality. Dr. Asgar noted this indication could warrant further studies, with a larger population, on using bivalirudin over UFH for women.

Dr. Asgar stated in the SCAI announcement, “Prior evidence has shown that while women have a higher rate of survival post TAVR, they are at a greater risk of complications from bleeding soon after a procedure. BRAVO 3 was designed to look at whether different anticoagulation medications could reduce the early risk in women.”

She concluded, “The good news is that we found early outcomes for women were comparable to those of men. That being said, the BRAVO 3 study only looked at outcomes over 30 days, so the next step would be to see long-term results for post-TAVR procedures.”