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SAN FRANCISCO – Rates of bleeding or vascular complications in women undergoing percutaneous coronary intervention were 59% lower using radial access, compared with femoral access, a difference that did not reach statistical significance in a randomized study of 1,787 patients.
Bleeding or vascular complications within 72 hours or at hospital discharge were seen in 1.2% of 345 women who had transradial percutaneous coronary intervention (PCI) and 2.9% of 345 women who had transfemoral PCI, Dr. Sunil V. Rao reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
Although that difference was not statistically significant in this prespecified analysis of patients who actually underwent PCI, the rate of bleeding and vascular complications was significantly lower for the group randomized to radial access in an analysis of the whole cohort, regardless of whether they had PCI or just diagnostic catheterization. Bleeding and vascular complication rates were 0.6% in those randomized to radial access and 1.7% in those randomized to femoral access,
In both the PCI cohort and the total cohort, significantly more women in the radial group needed to cross over to femoral access for PCI compared with the crossover rate in the femoral group. In the PCI cohort, 6.1% of the radial group crossed over, as did 1.7% of the femoral group. In the total cohort, crossover was needed in 6.7% of the radial group and 1.9% of the femoral group, said Dr. Rao of Duke University, Durham, N.C. The main reason for crossover from radial to femoral access was radial artery spasm, in 43% of cases.
The Study of Access Site for Enhancement of PCI for Women (SAFE-PCI) leveraged data from the National Cardiovascular Data Registry’s CathPCI Registry from 60 institutions on adult women undergoing elective or urgent PCI or undergoing diagnostic angiography to evaluate ischemic symptoms with the possibility of PCI. The primary outcome measure was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding events and vascular complications requiring intervention.
The investigators had planned to randomize 3,000 women to obtain 1,800 who underwent PCI, but a routine review after randomizing 1,120 patients suggested that the trial would be too small to show a difference because of lower-than-expected bleeding rates. Because no harm was noted in either the radial or femoral group, the investigators continued until they had enough patients for a quality-of-life substudy, then prematurely discontinued the trial.
The reduction in bleeding with the radial approach was similar to reductions seen in previous studies, Dr. Rao said at the meeting, cosponsored by the American College of Cardiology. The conversion rate from radial to femoral access was similar to the 7.6% rate reported in a prior trial (Lancet 2011;377:1409-20).
Compared with men, women have an increased risk for bleeding from antithrombotic therapy and from femoral access for PCI. Radial access can decrease bleeding risk, but transradial PCI has been less common in women, in part because they have smaller radial arteries.
The current trial’s results suggest that "an initial strategy of radial access is reasonable and may be preferred by some operators for women undergoing cardiac catheterization or PCI, with the recognition that a proportion of patients will require conversion to femoral access," he said.
Women preferred the radial approach over femoral access in the study, he added.
The results could be looked at as a glass half empty or half full, Dr. Roxana Mehran said as the discussant of the study at the meeting. She served on the executive committee of the SAFE-PCI trial.
In the eyes of a purist statistician, the results show no significant evidence that radial access prevents bleeding or vascular complications, the primary endpoint, said Dr. Mehran, professor of medicine and director of interventional cardiovascular research at Mount Sinai School of Medicine, New York.
From a clinician’s viewpoint, however, the estimates of benefit from radial access in the overall cohort and the PCI cohort were similar, yielding approximately a 60% reduction in bleeding with radial access, she noted. "The study provides evidence, albeit not conclusive, for greater efficacy with radial access in women," she said.
The crossover rates suggest that for every bleeding event or vascular complication prevented in the radial access group, three patients would cross over. "While there’s a higher crossover from [the] radial to the femoral approach, it’s reasonable and intuitive to begin with the radial approach in women," she said, "especially in those women at high risk for bleeding."
Dr. Rao has been a consultant for the Medicines Co., which helped fund the trial, and for AstraZeneca. Dr. Mehran reported financial associations with these companies and with Abbott Vascular and Daiichi-Sankyo/Eli Lilly & Co., which also funded the trial. Other funders of the study included Terumo Medical, Medtronic, ACIST Medical Systems, and Guerbet. Dr. Mehran also reported financial associations with nine other medical companies.
On Twitter @sherryboschert
I don’t think we have the data to say that this is a positive study or that we should change our practice because of these results. It’s an incomplete study, so we really don’t have the data. We need to think about why we didn’t have the anticipated enrollment and why the bleeding rate was lower than expected in the femoral access group. Those are the things that I think led to the futility. But it’s not really a negative trial. We simply don’t know whether radial access will be better in high-risk women undergoing PCI. It’s promising, and it makes all the sense in the world because of the bleeding risk in women.
Alice K. Jacobs, M.D., is a professor of medicine and director of the cardiac catheterization laboratory and interventional cardiology at Boston University. She gave these remarks at a press briefing. Dr. Jacobs reported having no relevant financial disclosures.
I don’t think we have the data to say that this is a positive study or that we should change our practice because of these results. It’s an incomplete study, so we really don’t have the data. We need to think about why we didn’t have the anticipated enrollment and why the bleeding rate was lower than expected in the femoral access group. Those are the things that I think led to the futility. But it’s not really a negative trial. We simply don’t know whether radial access will be better in high-risk women undergoing PCI. It’s promising, and it makes all the sense in the world because of the bleeding risk in women.
Alice K. Jacobs, M.D., is a professor of medicine and director of the cardiac catheterization laboratory and interventional cardiology at Boston University. She gave these remarks at a press briefing. Dr. Jacobs reported having no relevant financial disclosures.
I don’t think we have the data to say that this is a positive study or that we should change our practice because of these results. It’s an incomplete study, so we really don’t have the data. We need to think about why we didn’t have the anticipated enrollment and why the bleeding rate was lower than expected in the femoral access group. Those are the things that I think led to the futility. But it’s not really a negative trial. We simply don’t know whether radial access will be better in high-risk women undergoing PCI. It’s promising, and it makes all the sense in the world because of the bleeding risk in women.
Alice K. Jacobs, M.D., is a professor of medicine and director of the cardiac catheterization laboratory and interventional cardiology at Boston University. She gave these remarks at a press briefing. Dr. Jacobs reported having no relevant financial disclosures.
SAN FRANCISCO – Rates of bleeding or vascular complications in women undergoing percutaneous coronary intervention were 59% lower using radial access, compared with femoral access, a difference that did not reach statistical significance in a randomized study of 1,787 patients.
Bleeding or vascular complications within 72 hours or at hospital discharge were seen in 1.2% of 345 women who had transradial percutaneous coronary intervention (PCI) and 2.9% of 345 women who had transfemoral PCI, Dr. Sunil V. Rao reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
Although that difference was not statistically significant in this prespecified analysis of patients who actually underwent PCI, the rate of bleeding and vascular complications was significantly lower for the group randomized to radial access in an analysis of the whole cohort, regardless of whether they had PCI or just diagnostic catheterization. Bleeding and vascular complication rates were 0.6% in those randomized to radial access and 1.7% in those randomized to femoral access,
In both the PCI cohort and the total cohort, significantly more women in the radial group needed to cross over to femoral access for PCI compared with the crossover rate in the femoral group. In the PCI cohort, 6.1% of the radial group crossed over, as did 1.7% of the femoral group. In the total cohort, crossover was needed in 6.7% of the radial group and 1.9% of the femoral group, said Dr. Rao of Duke University, Durham, N.C. The main reason for crossover from radial to femoral access was radial artery spasm, in 43% of cases.
The Study of Access Site for Enhancement of PCI for Women (SAFE-PCI) leveraged data from the National Cardiovascular Data Registry’s CathPCI Registry from 60 institutions on adult women undergoing elective or urgent PCI or undergoing diagnostic angiography to evaluate ischemic symptoms with the possibility of PCI. The primary outcome measure was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding events and vascular complications requiring intervention.
The investigators had planned to randomize 3,000 women to obtain 1,800 who underwent PCI, but a routine review after randomizing 1,120 patients suggested that the trial would be too small to show a difference because of lower-than-expected bleeding rates. Because no harm was noted in either the radial or femoral group, the investigators continued until they had enough patients for a quality-of-life substudy, then prematurely discontinued the trial.
The reduction in bleeding with the radial approach was similar to reductions seen in previous studies, Dr. Rao said at the meeting, cosponsored by the American College of Cardiology. The conversion rate from radial to femoral access was similar to the 7.6% rate reported in a prior trial (Lancet 2011;377:1409-20).
Compared with men, women have an increased risk for bleeding from antithrombotic therapy and from femoral access for PCI. Radial access can decrease bleeding risk, but transradial PCI has been less common in women, in part because they have smaller radial arteries.
The current trial’s results suggest that "an initial strategy of radial access is reasonable and may be preferred by some operators for women undergoing cardiac catheterization or PCI, with the recognition that a proportion of patients will require conversion to femoral access," he said.
Women preferred the radial approach over femoral access in the study, he added.
The results could be looked at as a glass half empty or half full, Dr. Roxana Mehran said as the discussant of the study at the meeting. She served on the executive committee of the SAFE-PCI trial.
In the eyes of a purist statistician, the results show no significant evidence that radial access prevents bleeding or vascular complications, the primary endpoint, said Dr. Mehran, professor of medicine and director of interventional cardiovascular research at Mount Sinai School of Medicine, New York.
From a clinician’s viewpoint, however, the estimates of benefit from radial access in the overall cohort and the PCI cohort were similar, yielding approximately a 60% reduction in bleeding with radial access, she noted. "The study provides evidence, albeit not conclusive, for greater efficacy with radial access in women," she said.
The crossover rates suggest that for every bleeding event or vascular complication prevented in the radial access group, three patients would cross over. "While there’s a higher crossover from [the] radial to the femoral approach, it’s reasonable and intuitive to begin with the radial approach in women," she said, "especially in those women at high risk for bleeding."
Dr. Rao has been a consultant for the Medicines Co., which helped fund the trial, and for AstraZeneca. Dr. Mehran reported financial associations with these companies and with Abbott Vascular and Daiichi-Sankyo/Eli Lilly & Co., which also funded the trial. Other funders of the study included Terumo Medical, Medtronic, ACIST Medical Systems, and Guerbet. Dr. Mehran also reported financial associations with nine other medical companies.
On Twitter @sherryboschert
SAN FRANCISCO – Rates of bleeding or vascular complications in women undergoing percutaneous coronary intervention were 59% lower using radial access, compared with femoral access, a difference that did not reach statistical significance in a randomized study of 1,787 patients.
Bleeding or vascular complications within 72 hours or at hospital discharge were seen in 1.2% of 345 women who had transradial percutaneous coronary intervention (PCI) and 2.9% of 345 women who had transfemoral PCI, Dr. Sunil V. Rao reported at the Transcatheter Cardiovascular Therapeutics annual meeting.
Although that difference was not statistically significant in this prespecified analysis of patients who actually underwent PCI, the rate of bleeding and vascular complications was significantly lower for the group randomized to radial access in an analysis of the whole cohort, regardless of whether they had PCI or just diagnostic catheterization. Bleeding and vascular complication rates were 0.6% in those randomized to radial access and 1.7% in those randomized to femoral access,
In both the PCI cohort and the total cohort, significantly more women in the radial group needed to cross over to femoral access for PCI compared with the crossover rate in the femoral group. In the PCI cohort, 6.1% of the radial group crossed over, as did 1.7% of the femoral group. In the total cohort, crossover was needed in 6.7% of the radial group and 1.9% of the femoral group, said Dr. Rao of Duke University, Durham, N.C. The main reason for crossover from radial to femoral access was radial artery spasm, in 43% of cases.
The Study of Access Site for Enhancement of PCI for Women (SAFE-PCI) leveraged data from the National Cardiovascular Data Registry’s CathPCI Registry from 60 institutions on adult women undergoing elective or urgent PCI or undergoing diagnostic angiography to evaluate ischemic symptoms with the possibility of PCI. The primary outcome measure was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding events and vascular complications requiring intervention.
The investigators had planned to randomize 3,000 women to obtain 1,800 who underwent PCI, but a routine review after randomizing 1,120 patients suggested that the trial would be too small to show a difference because of lower-than-expected bleeding rates. Because no harm was noted in either the radial or femoral group, the investigators continued until they had enough patients for a quality-of-life substudy, then prematurely discontinued the trial.
The reduction in bleeding with the radial approach was similar to reductions seen in previous studies, Dr. Rao said at the meeting, cosponsored by the American College of Cardiology. The conversion rate from radial to femoral access was similar to the 7.6% rate reported in a prior trial (Lancet 2011;377:1409-20).
Compared with men, women have an increased risk for bleeding from antithrombotic therapy and from femoral access for PCI. Radial access can decrease bleeding risk, but transradial PCI has been less common in women, in part because they have smaller radial arteries.
The current trial’s results suggest that "an initial strategy of radial access is reasonable and may be preferred by some operators for women undergoing cardiac catheterization or PCI, with the recognition that a proportion of patients will require conversion to femoral access," he said.
Women preferred the radial approach over femoral access in the study, he added.
The results could be looked at as a glass half empty or half full, Dr. Roxana Mehran said as the discussant of the study at the meeting. She served on the executive committee of the SAFE-PCI trial.
In the eyes of a purist statistician, the results show no significant evidence that radial access prevents bleeding or vascular complications, the primary endpoint, said Dr. Mehran, professor of medicine and director of interventional cardiovascular research at Mount Sinai School of Medicine, New York.
From a clinician’s viewpoint, however, the estimates of benefit from radial access in the overall cohort and the PCI cohort were similar, yielding approximately a 60% reduction in bleeding with radial access, she noted. "The study provides evidence, albeit not conclusive, for greater efficacy with radial access in women," she said.
The crossover rates suggest that for every bleeding event or vascular complication prevented in the radial access group, three patients would cross over. "While there’s a higher crossover from [the] radial to the femoral approach, it’s reasonable and intuitive to begin with the radial approach in women," she said, "especially in those women at high risk for bleeding."
Dr. Rao has been a consultant for the Medicines Co., which helped fund the trial, and for AstraZeneca. Dr. Mehran reported financial associations with these companies and with Abbott Vascular and Daiichi-Sankyo/Eli Lilly & Co., which also funded the trial. Other funders of the study included Terumo Medical, Medtronic, ACIST Medical Systems, and Guerbet. Dr. Mehran also reported financial associations with nine other medical companies.
On Twitter @sherryboschert
AT TCT 2013
Major finding: Rates of bleeding or vascular complications were 1.2% using radial access and 2.9% using femoral access in the PCI subgroup and 6.7% and 1.9%, respectively, in the entire cohort.
Data source: A randomized study of 1,787 women undergoing definite or possible PCI at 60 institutions.
Disclosures: Dr. Rao has been a consultant for the Medicines Co., which helped fund the trial, and for AstraZeneca. Dr. Mehran reported financial associations with these companies and with Abbott Vascular and Daiichi-Sankyo/Eli Lilly & Co., which also funded the trial. Other funders of the study included Abbott Vascular, Daiichi-Sankyo/Eli Lilly & Co., Terumo Medical, Medtronic, ACIST Medical Systems, and Guerbet. Dr. Mehran also reported financial associations with nine other medical companies.
