No sex differences in carotid revascularization outcomes?

SAN FRANCISCO – There were no significant differences in endpoints between men and women after carotid endarterectomy or carotid artery stenting, results from a large registry study showed.

"These data suggest that, contrary to previous reports, women do not have a higher risk of adverse events after carotid revascularization," Dr. Jeffrey Jim said at the Society for Vascular Surgery Annual Meeting. "As such, women may derive similar benefits as men from carotid revascularization."

Carotid endarterectomy is considered by many as the gold standard treatment option for patients with severe internal carotid artery stenosis, said Dr. Jim, a vascular surgeon at Washington University School of Medicine, St. Louis. "Its benefit over best medical therapy has been proven by several landmark randomized controlled trials," he said. "While the efficacy of carotid artery stenting compared with carotid endarterectomy remains highly debated, there is clear utility in patients with select high risk criteria. However, it’s important to remember that gender plays an important role in cardiovascular disease. Epidemiologic studies clearly show that males have a higher stroke incidence as well as prevalence rate compared with women. However, when strokes do happen in women they tend to be more severe."

In terms of revascularization, he continued, available data suggested that women have a higher risk of perioperative adverse events compared with men, "suggesting that they may not benefit as much from revascularization compared with men."

He and other members of the SVS Outcomes Committee set out to evaluate the impact of gender on the outcomes after carotid revascularization (CAE and CAS), with the primary endpoint being composite risk of death, stroke, or MI at 30 days. They used data from 9,865 patients in the SVS Vascular Registry, which was developed in 2005 as a response to CMS approval of CAS. The registry was available to all clinical facilities and individual providers. "There are no specific inclusion or exclusion criteria because it aims to capture real-world results," Dr. Jim said. The registry is closed "but it remains one of the largest databases on carotid revascularization in the country."

Of the 9,865 patients 59% were men. There was no difference in age between sexes (both had a mean age of 71 years), but men were more likely to be symptomatic compared with women (42% vs. 39%, respectively).

For disease etiology in CAS, restenosis was higher in women compared with men (29% vs. 20%), while a greater proportion of men were being treated with radiation compared with women (6.2% vs. 2.6%). For CEA, more men were symptomatic compared with women (39% vs. 36%). "This was primarily driven by the fact that slightly more men than women had a stroke in the past (22% vs. 19%)," he said.

"Among patients overall, men had a slightly higher prevalence of coronary artery disease as well as MI, while women had a higher prevalence of hypertension as well as COPD," Dr. Jim said.

The researchers found no statistically significant differences in the composite endpoint of death, stroke, and MI at 30 days between men and women for either CEA (4.06% vs. 4.07%, respectively) or CAS (6.80% vs. 6.69%). The findings remained similar even after stratification by symptomatology and multivariate risk adjustment.

"In all the different ways we looked at it men and women had similar outcomes," Dr. Jim said. "This data is important. It’s representative of real-world outcomes, but there are limitations. It was an observational study done in a retrospective manner, and there is the potential for reporting bias. The most important limitation is that there is no comparison group of patients treated with best medical therapy. That’s an investigation that needs to be done going forward."

Dr. Jim said that he had no relevant financial conflicts to disclose.

[email protected]

SAN FRANCISCO – There were no significant differences in endpoints between men and women after carotid endarterectomy or carotid artery stenting, results from a large registry study showed.

"These data suggest that, contrary to previous reports, women do not have a higher risk of adverse events after carotid revascularization," Dr. Jeffrey Jim said at the Society for Vascular Surgery Annual Meeting. "As such, women may derive similar benefits as men from carotid revascularization."

Carotid endarterectomy is considered by many as the gold standard treatment option for patients with severe internal carotid artery stenosis, said Dr. Jim, a vascular surgeon at Washington University School of Medicine, St. Louis. "Its benefit over best medical therapy has been proven by several landmark randomized controlled trials," he said. "While the efficacy of carotid artery stenting compared with carotid endarterectomy remains highly debated, there is clear utility in patients with select high risk criteria. However, it’s important to remember that gender plays an important role in cardiovascular disease. Epidemiologic studies clearly show that males have a higher stroke incidence as well as prevalence rate compared with women. However, when strokes do happen in women they tend to be more severe."

In terms of revascularization, he continued, available data suggested that women have a higher risk of perioperative adverse events compared with men, "suggesting that they may not benefit as much from revascularization compared with men."

He and other members of the SVS Outcomes Committee set out to evaluate the impact of gender on the outcomes after carotid revascularization (CAE and CAS), with the primary endpoint being composite risk of death, stroke, or MI at 30 days. They used data from 9,865 patients in the SVS Vascular Registry, which was developed in 2005 as a response to CMS approval of CAS. The registry was available to all clinical facilities and individual providers. "There are no specific inclusion or exclusion criteria because it aims to capture real-world results," Dr. Jim said. The registry is closed "but it remains one of the largest databases on carotid revascularization in the country."

Of the 9,865 patients 59% were men. There was no difference in age between sexes (both had a mean age of 71 years), but men were more likely to be symptomatic compared with women (42% vs. 39%, respectively).

For disease etiology in CAS, restenosis was higher in women compared with men (29% vs. 20%), while a greater proportion of men were being treated with radiation compared with women (6.2% vs. 2.6%). For CEA, more men were symptomatic compared with women (39% vs. 36%). "This was primarily driven by the fact that slightly more men than women had a stroke in the past (22% vs. 19%)," he said.

"Among patients overall, men had a slightly higher prevalence of coronary artery disease as well as MI, while women had a higher prevalence of hypertension as well as COPD," Dr. Jim said.

The researchers found no statistically significant differences in the composite endpoint of death, stroke, and MI at 30 days between men and women for either CEA (4.06% vs. 4.07%, respectively) or CAS (6.80% vs. 6.69%). The findings remained similar even after stratification by symptomatology and multivariate risk adjustment.

"In all the different ways we looked at it men and women had similar outcomes," Dr. Jim said. "This data is important. It’s representative of real-world outcomes, but there are limitations. It was an observational study done in a retrospective manner, and there is the potential for reporting bias. The most important limitation is that there is no comparison group of patients treated with best medical therapy. That’s an investigation that needs to be done going forward."

Dr. Jim said that he had no relevant financial conflicts to disclose.

[email protected]

SAN FRANCISCO – There were no significant differences in endpoints between men and women after carotid endarterectomy or carotid artery stenting, results from a large registry study showed.

"These data suggest that, contrary to previous reports, women do not have a higher risk of adverse events after carotid revascularization," Dr. Jeffrey Jim said at the Society for Vascular Surgery Annual Meeting. "As such, women may derive similar benefits as men from carotid revascularization."

Carotid endarterectomy is considered by many as the gold standard treatment option for patients with severe internal carotid artery stenosis, said Dr. Jim, a vascular surgeon at Washington University School of Medicine, St. Louis. "Its benefit over best medical therapy has been proven by several landmark randomized controlled trials," he said. "While the efficacy of carotid artery stenting compared with carotid endarterectomy remains highly debated, there is clear utility in patients with select high risk criteria. However, it’s important to remember that gender plays an important role in cardiovascular disease. Epidemiologic studies clearly show that males have a higher stroke incidence as well as prevalence rate compared with women. However, when strokes do happen in women they tend to be more severe."

In terms of revascularization, he continued, available data suggested that women have a higher risk of perioperative adverse events compared with men, "suggesting that they may not benefit as much from revascularization compared with men."

He and other members of the SVS Outcomes Committee set out to evaluate the impact of gender on the outcomes after carotid revascularization (CAE and CAS), with the primary endpoint being composite risk of death, stroke, or MI at 30 days. They used data from 9,865 patients in the SVS Vascular Registry, which was developed in 2005 as a response to CMS approval of CAS. The registry was available to all clinical facilities and individual providers. "There are no specific inclusion or exclusion criteria because it aims to capture real-world results," Dr. Jim said. The registry is closed "but it remains one of the largest databases on carotid revascularization in the country."

Of the 9,865 patients 59% were men. There was no difference in age between sexes (both had a mean age of 71 years), but men were more likely to be symptomatic compared with women (42% vs. 39%, respectively).

For disease etiology in CAS, restenosis was higher in women compared with men (29% vs. 20%), while a greater proportion of men were being treated with radiation compared with women (6.2% vs. 2.6%). For CEA, more men were symptomatic compared with women (39% vs. 36%). "This was primarily driven by the fact that slightly more men than women had a stroke in the past (22% vs. 19%)," he said.

"Among patients overall, men had a slightly higher prevalence of coronary artery disease as well as MI, while women had a higher prevalence of hypertension as well as COPD," Dr. Jim said.

The researchers found no statistically significant differences in the composite endpoint of death, stroke, and MI at 30 days between men and women for either CEA (4.06% vs. 4.07%, respectively) or CAS (6.80% vs. 6.69%). The findings remained similar even after stratification by symptomatology and multivariate risk adjustment.

"In all the different ways we looked at it men and women had similar outcomes," Dr. Jim said. "This data is important. It’s representative of real-world outcomes, but there are limitations. It was an observational study done in a retrospective manner, and there is the potential for reporting bias. The most important limitation is that there is no comparison group of patients treated with best medical therapy. That’s an investigation that needs to be done going forward."

Dr. Jim said that he had no relevant financial conflicts to disclose.

[email protected]