While sex disparities regarding the outcomes of carotid revascularisation have “long been a concern”, new prospective data published in the Journal of Vascular Surgery (JVS) indicate that no such disparity exists between male and female patients treated with transcarotid artery revascularisation (TCAR; Silk Road Medical)—one of the most prominent approaches used to treat carotid artery stenosis.
Writing in JVS on behalf of the ROADSTER trial investigators, Vikram Kashyap (Frederik Meijer Heart and Vascular Institute at Corewell Health, Grand Rapids, USA) and colleagues report “exceptionally low” rates of stroke, death and myocardial infarction (MI) derived from prospective TCAR trial data. They further note that these low rates “do not differ by patient sex”.
Previously, several studies of carotid revascularisation have demonstrated increased frequencies of postoperative death and stroke for female patients after either carotid endarterectomy (CEA), or transfemoral carotid artery stenting (CAS). In addition, adverse events after transfemoral stenting are higher in female patients, particularly in symptomatic cases, the authors relay.
In prospectively analysing results from the ROADSTER 1, ROADSTER 2 and ROADSTER Extended Access TCAR trials, Kashyap and colleagues’ objective was to investigate post-TCAR outcomes stratified by patient sex. They hypothesised that the results would be similar between males and females.
All included patients had verified carotid stenoses meeting the criteria for carotid intervention (≥80% in asymptomatic and ≥50% in symptomatic patients), and were included based on anatomical or clinical high-risk criteria for carotid stenting. The researchers’ primary outcomes were a combination of stroke/death (S/D) and stroke/death/MI (S/D/M) at 30 days, while secondary outcomes were the individual components of stroke, death, and MI.
Kashyap and colleagues included a total of 910 patients for analysis, roughly two thirds of whom were male (n=604; 66.4%). They note that female patients were more often <65 years old (20.6% vs 15%) or ≥80 years old (22.6% vs 20.2%), and were more often of Black/African American ethnicity (7.5% vs 4.3%), as compared with their male counterparts.
“There were no differences by sex in term of comorbidities, current or prior smoking status, prior stroke, symptomatic status, or prevalence of anatomical and/or clinical high-risk criteria,” the authors disseminate. “General anaesthetic use, stent brands used and procedure times did not differ by sex—although flow reversal times were longer in female patients, [and] more contrast [was] used in procedures for female patients.”
In addition, both the 30-day rates of S/D (2.7% male vs 1.6% female) and S/D/M (3.6% male vs 2.6% female) were similar between the two groups of sex-stratified patients. The researchers also found that these key outcome measures did not differ when patients were stratified by symptom status either. Comparable findings were identified in terms of secondary outcomes—including stroke rates at 30 days—too.
“Univariate analysis demonstrated that history of a prior ipsilateral stroke was associated with increased odds of S/D (odds ratio [OR] 4.19) and S/D/M (OR 2.78), as was symptomatic presentation with increased odds for S/D (OR 2.78),” Kashyap and colleagues aver in conclusion.