BRAVO 3: Outcomes after transfemoral TAVR do not vary by sex

ORLANDO, Fla. — In the BRAVO 3 study population of patients undergoing transfemoral transcatheter aortic valve replacement, outcomes did not differ between men and women, according to data presented at the Society for Cardiovascular Angiography and Interventions Scientific Sessions.

This is the first contemporary TAVR study that did not show a higher rate of major vascular complications for women than for men, likely because newer-generation TAVR systems with smaller sheaths were commonly used, and the study included TAVR procedures via transfemoral access only, Anita W. Asgar, MD, interventional cardiologist at Montreal Heart Institute, said during a presentation.

Anita W. Asgar

“We have an impression that women do worse than men during …TAVR because of vascular complications and major bleeding, but it is based on … data that includes patients treated with transfemoral TAVR and alternative access,” Asgar told Cardiology Today’s Intervention. “A lot of the bleeding complications must be coming from [patients requiring alternative access], because we saw no difference in men vs. women in this cohort. This shows us that if you’re a woman and can have transfemoral TAVR, you’re likely not going to do any worse than your male counterpart. That’s a very important message.”

In the main study, patients were randomly assigned bivalirudin (Angiomax, The Medicines Company) or unfractionated heparin during transfemoral TAVR, and no differences in outcomes between the two groups were observed.

Asgar and colleagues conducted a post hoc analysis to determine sex-based differences in BARC 3b or higher major bleeding at 48 hours or hospital discharge and 30-day net adverse clinical events (NACE), defined as death, MI, stroke and major bleeding.

Of the 391 women in the study, 195 were assigned bivalirudin and 196 were assigned heparin. Of the 411 men, 209 were assigned bivalirudin and 202 were assigned heparin.

Compared with men, women were older (84 years vs. 81 years; P < .0001), weighed less (67.6 kg vs. 80.3 kg; P < .0001), had less CAD (37.7% vs. 62.8%; P < .0001) and had improved left ventricular ejection fraction (56.4% vs. 51%; P < .0001). Women were also less likely to have had MI or undergone CABG, Asgar said.

As expected, women were more likely to need smaller sheaths during TAVR (< 18F: 38.2% women vs. 27.2% men; P < .0001), she said.

At 48 hours, the sexes had similar rates of BARC 3b or higher bleeding (women, 8.2%; men, 7.8%; P = .83) and major vascular complications (women, 10.5%; men, 7.3%; P = .11), according to the researchers.

At 30 days, rates of NACE were 16% in women vs. 15% in men (P = .63).

“We’re making the devices smaller, and we’re getting the best [results] if the procedure can be done transfemorally,” Asgar said in an interview. “Hopefully we will be able to alleviate any untoward complications that occur in patients who can’t have transfemoral TAVR.”

For both women and men, anticoagulation assignment had no significant effect on the primary outcomes, Asgar said.

“As reassuring as it is that women don’t do worse than men, I’m still asking myself why women don’t do better than men,” she said. “They have less comorbidities, they have better long-term survival. In my mind, they should be doing much better than what we’re seeing. I’d like the research move in a direction where we try to optimize results for patients on a more personalized basis.”

Only two women assigned bivalirudin died at 48 hours vs. seven assigned heparin. Asgar said there was a signal that bivalirudin might confer benefit to women in all-cause mortality (P for interaction = .0098) and CV mortality (P for interaction = .0187). There was still a trend toward an interaction at 30 days but it was no longer statistically significant.

“This perhaps needs to be investigated in more detail,” Asgar told Cardiology Today’s Intervention. – by Erik Swain

Reference:

Asgar AW, et al. Late-Breaking Clinical Trials – Part 3. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 4-7, 2016; Orlando, Fla.

Disclosure: Asgar reports receiving research support from Abbott and consultant/speaker honoraria from Abbott, Edwards Lifesciences, Gore and Medtronic.