Carotid Procedures Pose Equal Risk to Women, Men

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Despite previous studies to the contrary, women do not have a higher risk of adverse events after carotid revascularization—either endovascular or surgical—compared with their male counterparts. The findings come from a large, real-world registry published online November 15, 2013, ahead of print in the Journal of Vascular Surgery.

The results were first presented earlier this year at the 2013 Vascular Annual Meeting of the Society for Vascular Surgery in San Francisco, CA.

Jeffrey Jim, MD, of the Washington University School of Medicine (St. Louis, MO), and colleagues looked at 9,865 patients who underwent carotid endarterectomy (CEA, n=6,492) or carotid artery stenting (CAS, n=3,373) and were enrolled in the Society for Vascular Surgery Vascular Registry. Less than half of the total cohort (40.6%, n=4,008) were women.

Slightly more women underwent CEA (41.3%) than CAS (39.4%).

Similar Rates of Death, Stroke, MI

Among the CEA cohort, there was no difference in 30-day outcomes according to gender (table 1).

Table 1. Thirty-day Outcomes After CEA by Gender

 The same was true for CAS patients (table 2).

Table 2. Thirty-day Outcomes After CAS by Gender

Even after risk adjustment, there remained no difference between women and men undergoing CEA in the 30-day risk of death, stroke, or MI (OR 1.15; 95% CI 0.89-1.48; P = 0.2958). The same was true for women and men undergoing CAS (OR 0.91; 95% CI 0.68-1.21; P = 0.5115).

Both gender groups had a similar 30-day composite rate of death/stroke, and MI: about 4% for CEA and 7% for CAS. In CEA patients, those who were asymptomatic had the lowest event rates, with the 30-day primary composite (death, stroke, and MI) occurring in 3.03% of women and 3.19% of men. The rate was higher in symptomatic patients, at 5.94% in women vs. 5.42% in men, though there was no difference in risk after adjustment.

In CAS patients who were symptomatic, the event rate was somewhat higher in women (5.79% vs. 4.55%; P = 2.353), though the difference was not statistically significant. There was also a higher rate of the composite endpoint in symptomatic men vs. women undergoing CAS (9.42% vs. 7.84%; P = 0.3088). Again, after risk adjustment, no differences remained between women and men.

Data Run Counter to Previous Studies Showing Different Risk Level in Women

The authors note that despite the emergence of revascularization as an important option for patients with carotid occlusive disease, the benefits of such procedures in women have remained unclear. In fact, studies such as ACAS, NASCET, ICSS, and CREST have shown lower periprocedural events in women undergoing CEA, but higher in women receiving CAS. “In terms of revascularization, the available literature suggests that women have higher risk of perioperative adverse events,” they note. “This thus puts into question how much women actually benefit from carotid revascularization compared with men.”

The current registry, though, one of the largest published real-world databases of US carotid revascularization, suggests that, “contrary to previous reports, women do not have a higher risk of adverse events after carotid revascularization,” the authors affirm.

Still, “it is conceivable that these results, while they don’t show a difference in surgical outcome, still do not prove the hypothesis that for asymptomatic patients there is as much benefit for men as women,” commented Joseph J. Ricotta, II, MD, of Emory University School of Medicine (Atlanta, GA), in a published discussion following the report.

Dr. Jim responded that in the past, hesitation in treating women has come from 2 main factors: “One is the fact that there was a higher rate of perioperative events, and the second one was that women tend to just have fewer events on medical therapy. Our study essentially is able to only address the first part. We were able to compare men and women essentially showing that they have equivalent surgical outcomes. But,” he cautions, “we did not have data on treatment with optimal medical therapy alone. And. . . . potentially, that is the group that has the best results and certainly do not need intervention.”

Study Details

The analysis was limited to patients treated for carotid disease caused by atherosclerosis, radiation, and restenosis. Men and women had a similar age (71 years) and ethnicity profile (> 92% Caucasian). Men were more likely to be symptomatic (39.2% vs. 35.8%; P < 0.007), driven by a higher previous history of stroke (22.2% vs. 19.2%; P = 0.004). For CAS patients, women had a higher prevalence of restenosis (28.7% vs. 19.7%), and men were more likely to be treated for radiation-induced disease (6.2% vs. 2.6%).

 

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Source:
Jim J, Dillavou ED, Upchurch GR, et al. Gender-specific 30-day outcomes after carotid endarterectomy and carotid artery stenting in the Society for Vascular Surgery Vascular Registry. J Vasc Surg. 2013; Epub ahead of print.

 

Disclosures:

• The study was supported by funds from the Society for Vascular Surgery.
• Dr. Jim reports no relevant conflicts of interest.

 

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