Men and women who underwent transcatheter aortic valve replacement (TAVR) had similar rates of survival, major adverse cardiovascular events and vascular complications at 30 days, according to a randomized trial.
Lead researcher Anita W. Asgar, MD, of the Montreal Heart Institute, presented the results of the study during a late-breaking clinical trial session at the Society for Cardiovascular Angiography and Interventions scientific sessions on May 6 in Orlando.
“This is the first time that we haven’t seen a difference [between men and women],” Asgar said at a news conference. “Most of the major trials prior to this one did show that women had more vascular complications than men and more early bleeding, although they had better long-term mortality benefits.”
The researchers analyzed the BRAVO 3 trial, which randomized 802 high-risk patients undergoing transfemoral TAVR at 31 centers in North America and Europe to receive bivalirudin or unfractionated heparin. The study enrolled 391 women and 411 men. The study showed that bivalirudin was noniferior to unfractionated heparin.
At baseline, women were older than men and had fewer comorbidities such as coronary artery disease, atrial fibrillation and diabetes. Women also received smaller sheath and device sizes. The use of vascular closure devices was similar between men and women.
At 30 days, the mortality rates were 4.6 percent in men and 4.9 percent in women, the rates of major adverse cardiovascular events were 8.3 percent and 7.4 percent, respectively, and the rates of vascular complications were 7.8 percent and 11.0 percent, respectively. The researchers defined major adverse cardiovascular events as a composite of 30-day death, MI or stroke.
In addition, the rates of major bleeding at 48 hours were 10.5 percent in men and 9.0 percent in women and the rates of net adverse cardiovascular events at 30 days were 14.8 percent and 15.6 percent, respectively. The researchers defined major bleeding as Bleeding Academic Research Consortium (BARC) type 3b bleeding and net adverse cardiovascular events as the composite of BARC 3b bleeding or major adverse cardiovascular events.
None of the differences between men and women were statistically significant.
“Despite a similar rate of major bleeding, there tended to be a small potential benefit with bivalirudin and lower mortality in women,” Asgar said. “This is a subgroup analysis, a post-hoc analysis. It really just needs to be investigated in future studies. But there was perhaps a suggestion that there may be a benefit in women with bivalirudin in terms of lower mortality. That’s really hypothesis generating at this point.”