BRAVO 3 Compares Bivalirudin to Heparin for TAVR

October 15, 2015—Results from the BRAVO 3 trial found that bivalirudin (Angiox, The Medicines Company) did not significantly reduce rates of major bleeding at 48 hours or adverse events at 30 days compared to heparin in high-risk patients undergoing transcatheter aortic valve replacement (TAVR).

Findings from the BRAVO 3 study were presented at TCT 2015, at the 27th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation being held October 11–15, in San Francisco, California. The study results were also published online ahead of print in the Journal of the American College of Cardiology. The trial was sponsored by The Medicines Company. 

The phase 3b, open-label, randomized study was conducted 31 sites in seven countries. Investigators enrolled 802 patients (≥ 18 years of age) with aortic stenosis who were at a high surgical risk (Euroscore ≥ 18 or considered inoperable) and scheduled for TAVR via transfermoral access. The patients were randomized in a 1:1 ratio to receive bivalirudin (n = 404) or unfractionated heparin (n = 398). The 30-day follow-up rate was 97.5% for patients in the bivalirudin group (n = 394) and 97.5% for the heparin group (n = 388).

The investigators reported that anticoagulation with bivalirudin versus heparin was associated with a nonsignificantly different rate of major bleeding at 48 hours (6.9% vs 9%; relative risk [RR], 0.77; 95% confidence interval [CI], 0.48 to 1.23; P = .27). The rates of net adverse cardiovascular events at 30 days were also similar (14.4% vs 16.1%; RR. 0.89; 95% CI, 0.64 to 1.24; risk difference, –1.72; 95% CI –6.7 to 3.25; P = .5). Regarding the latter, the prespecified noninferiority hypothesis was met (P-noninferiority < .01). Rates of bleeding events or major adverse cardiovascular events after 48 hours were not significantly different.

BRAVO 3’s lead investigator is Thierry Lefevre, MD, an interventional cardiologist from Institut Hospitalier Jacques Cartier in Massy, France. In the TCT press release, Dr. Lefevre commented, “In patients undergoing transfemoral TAVR with severe symptomatic aortic stenosis, procedural anticoagulation with bivalirudin did not significantly reduce the primary outcomes of major bleeding at 48 hours or net adverse cardiac events at 30 days compared with heparin.”

Dr. Cartier added, “Despite not achieving superiority, noninferiority was met and no safety concern was identified. Given the lower cost, heparin should remain the standard of care, and bivalirudin can be an alternative anticoagulant in patients not able to receive heparin.”