A study on the impact of using different anticoagulation medications on men and women who have undergone a transcatheter aortic valve replacement (TAVR) has 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, USA.
BRAVO 3 assessed contemporary TAVR procedures administered through the leg, or transfemoral procedures, and compared the use of two anticoagulation medications, bivalirudin and unfractionated heparin (UFH). The study was a randomised multicentre trial with 31 centres participating (n=802). The primary endpoint was major bleeding occurring within 48 hours. Major bleeding was defined as Bleeding Academic Research Consortium (BARC) type 3b, which is overt bleeding with a significant drop in haemoglobin or that requires surgical intervention and/or IV vasoactive agents to control.
“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,” says Anita W Asgar, the paper’s lead author. “BRAVO 3 was designed to look at whether different anticoagulation medications could reduce the early risk in women.”
The study was comprised 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 in the population were older than men and had fewer comorbidities, such as coronary artery disease, atrial fibrillation and diabetes. While women had a lower EuroSCORE I— a predictor of operative mortality in patients undergoing cardiac surgery—all patients were considered high-risk for TAVR.
Compared with men, at 30 days, women demonstrated similar survival (19 men vs. 19 women, p=0.87), major adverse cardiac event (34 men vs. 29 women, p=0.65) and vascular complications (32 men vs. 43 women, p=0.12).
“The good news is that we found early outcomes for women were comparable to those of men,” says Asgar. “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.”
BRAVO 3 did find a trend—although not statistically significant—that women who were given bivalirudin experienced less mortality. Asgar noted that this indication could warrant further studies, with a larger population, on using bivalirudin over UFH for women.