ORLANDO — Outcomes within 30 days were similar between sexes after transcatheter aortic valve replacement (TAVR) via transfemoral access, according to a late-breaking investigation presented here.
By 48 hours, neither sex had an advantage in short-term major bleeding (8.20% for women versus 7.80% for men, P=0.83). Similarly, no sex difference was found for combined death, myocardial infarction, stroke, and major bleeding up to 30 days (16% versus 15%, P=0.63), reported Anita W. Asgar, MD, of Montreal Heart Institute, at the Society for Cardiovascular Angiography and Interventions (SCAI) annual meeting.
“The good news is that we found early outcomes for women were comparable to those of men,” Asgar said in a press release.
Also, among the anticoagulants studied, there was a trend toward fewer deaths at 48 hours when women took bivalirudin (1.0% versus 3.6% with unfractionated heparin, P=0.175, P-interaction=0.0098).
“For the first time in contemporary transfemoral TAVR, women experienced similar rate[s] of early major bleeding and vascular complications as men,” Asgar concluded. “Despite similar rates of major bleeding, a potential benefit with bivalirudin and lower mortality in women needs to be investigated in future studies.”
The study was a secondary analysis of data from BRAVO 3, a phase III, open-label trial that randomized 802 high-risk TAVR patients to bivalirudin or unfractionated heparin. Main results reported last year indicated that bivalirudin was non-inferior to heparin when it came to bleeding and cardiac event rates.
In the present substudy, women were associated with older age at baseline but, when compared with men, had less diabetes (25.3% versus 34.1%, P=0.0068) and coronary artery disease (37.7% versus 62.8%, P<0.0001).
Asgar acknowledged that her study did not account for protamine use or patient frailty, among other potential confounders. Longer-term data is yet to come as well, she added.
Panelist Bonnie Weiner, MD, of Worcester Medical Center in Massachusetts, noted the selection bias inherent in the investigation as some women may not be eligible for transfemoral access.
Discussion moderator Robert J. Applegate, MD, of Wake Forest Baptist Medical Center in Winston-Salem, N.C., raised the question: “When you do post-hoc analyses and there are baseline differences but equivalent outcomes … isn’t that indirect evidence of worse outcomes?” It appears that clinicians will have to wait for future studies — those powered for full sex subanalysis, at that — for the answer to that question.
Asgar disclosed no relevant conflicts of interest.
Society for Cardiovascular Angiography and Interventions
Asgar A, et al “Sex-based differences in outcomes with bivalirudin or unfractionated heparin for transcatheter aortic valve replacement: results from the BRAVO 3 randomized trial” SCAI 2016.