Panthofer, Annalise M.

Introduction: Previous analyses of randomized trials comparing carotid artery stenting (CAS) versus carotid endarterectomy (CEA) have revealed varying sex-associated risk. To better understand sex as an effect modifier in the asymptomatic population, we combined the asymptomatic patients from CREST with the asymptomatic patients from ACT I. Methods: We analyzed data from 2544 subjects with ≥ 70% carotid stenosis randomized to CAS or CEA in addition to standard management of cardiovascular risk factors. CREST enrolled 1091 (548 CAS, 543 CEA) and ACT I enrolled 1453 (1089 CAS, 364 CEA) asymptomatic patients less than 80 years old (upper age eligibility in ACT I). We examined the impact of sex on risk within CAS-treated and CEA-treated patients using Kaplan-Meier methods. The pre-specified, primary composite endpoint was stroke, myocardial infarction, or death during the periprocedural period (within 30 days of randomization) or any ipsilateral stroke within 4 years after randomization. Results: For patients assigned to CAS, there was no difference in risk between the sexes (female-to-male HR = 1.04, 95% CI 0.65 -- 1.66, P = 0.87). For patients assigned to CEA, the difference in risk detected was not significant (female-to-male HR = 1.43, 95% CI 0.77 - 2.67, P = 0.26). Conclusions: Sex-differences in risk were not significant for those assigned CAS nor those assigned CEA in this largest pooled analysis of asymptomatic patients comparing CAS to CEA.