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ORLANDO, FL—There are no significant gender-based differences in early outcomes for patients receiving anticoagulants after a transcatheter aortic valve replacement (TAVR), according to the BRAVO 3 trial.
The trial showed no difference between men and women with regard to major bleeding at 48 hours or vascular complications, major adverse cardiac events, and mortality at 30 days.
The results did reveal a trend toward improved survival for women who received bivalirudin as opposed to unfractionated heparin (UFH), but the difference was not significant.
These results were presented at the Society for Cardiovascular Angiography and Interventions (SCAI) 2016 Scientific Sessions (abstract available here).
The trial enrolled 802 patients who underwent contemporary TAVR procedures administered through the leg and received either bivalirudin or UFH.
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 hemoglobin or that requires surgical intervention and/or intravenous 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,” said study investigator Anita W. Asgar, MD, of the Montreal Heart Institute in Quebec, Canada.
“BRAVO 3 was designed to look at whether different anticoagulation medications could reduce the early risk in women.”
Of the 391 women in the study, 195 received bivalirudin and 196 received UFH. Of the 411 men, 209 received bivalirudin and 202 received UFH.
Women 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.
By 48 hours, there was no significant difference between the sexes in major bleeding, which occurred in 8.2% of women and 7.8% of men (P=0.83).
Likewise, there was no significant difference in the incidence of death, myocardial infarction, stroke, and major bleeding combined at 30 days. The incidence was 16% in women and 15% in men (P=0.63).
Nineteen patients in each group were still alive at 30 days (P=0.87), 34 men and 29 women had a major adverse cardiac event (P=0.65), and 32 men and 43 women had vascular complications (P=0.12).
“The good news is that we found early outcomes for women were comparable to those of men,” Dr 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 reveal a trend—although it was not statistically significant—that women who received bivalirudin had superior survival. Dr Asgar noted this indication could warrant further studies, with a larger population, on using bivalirudin over UFH for women. 
ORLANDO, FL—There are no significant gender-based differences in early outcomes for patients receiving anticoagulants after a transcatheter aortic valve replacement (TAVR), according to the BRAVO 3 trial.
The trial showed no difference between men and women with regard to major bleeding at 48 hours or vascular complications, major adverse cardiac events, and mortality at 30 days.
The results did reveal a trend toward improved survival for women who received bivalirudin as opposed to unfractionated heparin (UFH), but the difference was not significant.
These results were presented at the Society for Cardiovascular Angiography and Interventions (SCAI) 2016 Scientific Sessions (abstract available here).
The trial enrolled 802 patients who underwent contemporary TAVR procedures administered through the leg and received either bivalirudin or UFH.
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 hemoglobin or that requires surgical intervention and/or intravenous 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,” said study investigator Anita W. Asgar, MD, of the Montreal Heart Institute in Quebec, Canada.
“BRAVO 3 was designed to look at whether different anticoagulation medications could reduce the early risk in women.”
Of the 391 women in the study, 195 received bivalirudin and 196 received UFH. Of the 411 men, 209 received bivalirudin and 202 received UFH.
Women 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.
By 48 hours, there was no significant difference between the sexes in major bleeding, which occurred in 8.2% of women and 7.8% of men (P=0.83).
Likewise, there was no significant difference in the incidence of death, myocardial infarction, stroke, and major bleeding combined at 30 days. The incidence was 16% in women and 15% in men (P=0.63).
Nineteen patients in each group were still alive at 30 days (P=0.87), 34 men and 29 women had a major adverse cardiac event (P=0.65), and 32 men and 43 women had vascular complications (P=0.12).
“The good news is that we found early outcomes for women were comparable to those of men,” Dr 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 reveal a trend—although it was not statistically significant—that women who received bivalirudin had superior survival. Dr Asgar noted this indication could warrant further studies, with a larger population, on using bivalirudin over UFH for women.
ORLANDO, FL—There are no significant gender-based differences in early outcomes for patients receiving anticoagulants after a transcatheter aortic valve replacement (TAVR), according to the BRAVO 3 trial.
The trial showed no difference between men and women with regard to major bleeding at 48 hours or vascular complications, major adverse cardiac events, and mortality at 30 days.
The results did reveal a trend toward improved survival for women who received bivalirudin as opposed to unfractionated heparin (UFH), but the difference was not significant.
These results were presented at the Society for Cardiovascular Angiography and Interventions (SCAI) 2016 Scientific Sessions (abstract available here).
The trial enrolled 802 patients who underwent contemporary TAVR procedures administered through the leg and received either bivalirudin or UFH.
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 hemoglobin or that requires surgical intervention and/or intravenous 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,” said study investigator Anita W. Asgar, MD, of the Montreal Heart Institute in Quebec, Canada.
“BRAVO 3 was designed to look at whether different anticoagulation medications could reduce the early risk in women.”
Of the 391 women in the study, 195 received bivalirudin and 196 received UFH. Of the 411 men, 209 received bivalirudin and 202 received UFH.
Women 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.
By 48 hours, there was no significant difference between the sexes in major bleeding, which occurred in 8.2% of women and 7.8% of men (P=0.83).
Likewise, there was no significant difference in the incidence of death, myocardial infarction, stroke, and major bleeding combined at 30 days. The incidence was 16% in women and 15% in men (P=0.63).
Nineteen patients in each group were still alive at 30 days (P=0.87), 34 men and 29 women had a major adverse cardiac event (P=0.65), and 32 men and 43 women had vascular complications (P=0.12).
“The good news is that we found early outcomes for women were comparable to those of men,” Dr 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 reveal a trend—although it was not statistically significant—that women who received bivalirudin had superior survival. Dr Asgar noted this indication could warrant further studies, with a larger population, on using bivalirudin over UFH for women.