Female and male patients have similar outcomes after transcarotid artery revascularization in prospective trials.

Autor:	Smith JA; Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Cleveland, OH., Chung JM; Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Cleveland, OH., Schneider PA; Division of Vascular and Endovascular Surgery, University of California San Francisco, San Francisco, CA., Kwolek CJ; Division of Vascular and Endovascular Surgery of the General Surgical Services, Massachusetts General Hospital, Boston, MA., Arko FR; Sanger Hearth & Vascular Institute, Atrium Health Carolinas Medical Center, Charlotte, NC., Henao S; Presbyterian Hospital, Albuquerque, NM., Titus J; Essentia Health, Duluth, MN., DiMuzio P; Division of Vascular and Endovascular Surgery, Thomas Jefferson University Hospital, Philadelphia, PA., Roddy S; Division of Vascular Surgery, Albany Medical College, Albany, NY., Farber MA; Divison of Vascular Surgery, University of North Carolina School of Medicine, Chapel Hill, NC., Kashyap VS; Frederik Meijer Heart and Vascular Institute, Corewell Health, Grand Rapids, MI. Electronic address: vikram.kashyap@corewellhealth.org.
Jazyk:	angličtina
Zdroj:	Journal of vascular surgery [J Vasc Surg] 2024 Jan; Vol. 79 (1), pp. 81-87.e1. Date of Electronic Publication: 2023 Sep 15.
DOI:	10.1016/j.jvs.2023.09.007
Abstrakt:	Objective: Sex disparities in outcomes after carotid revascularization have long been a concern, with several studies demonstrating increased postoperative death and stroke for female patients after either carotid endarterectomy or transfemoral stenting. Adverse events after transfemoral stenting are higher in female patients, particularly in symptomatic cases. Our objective was to investigate outcomes after transcarotid artery revascularization (TCAR) stratified by patient sex hypothesizing that the results would be similar between males and females. Methods: We analyzed prospectively collected data from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER)1 (pivotal), ROADSTER2 (US Food and Drug Administration indicated postmarket), and ROADSTER Extended Access TCAR trials. All patients had verified carotid stenosis meeting criteria for intervention (≥80% for asymptomatic patients and ≥50% in patient with symptomatic disease), and were included based on anatomical or clinical high-risk criteria for carotid stenting. Neurological assessments (National Institutes of Health Stroke Scale, Modified Rankin Scale) were obtained before and within 24 hours from procedure end by an independent neurologist or National Institutes of Health Stroke Scale-certified nurse. Patients were stratified by sex (male vs female). Baseline demographics were compared using χ 2 and Fisher's exact tests where appropriate; primary outcomes were combination stroke/death (S/D) and S/D/myocardial infarction (S/D/M) at 30 days, and secondary outcomes were the individual components of S/D/M. Univariate logistic regression was conducted. Results: We included 910 patients for analysis (306 female [33.6%], 604 male [66.4%]). Female patients were more often <65 years old (20.6% vs 15%) or ≥80 years old (22.6% vs 20.2%) compared with males, and were more often of Black/African American ethnicity (7.5% vs 4.3%). 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. General anesthetic use, stent brands used, and procedure times did not differ by sex, although flow reversal times were longer in female patients (10.9 minutes male vs 12.4 minutes female; P = .01), as was more contrast used in procedures for female patients (43 mL male vs 48.9 mL female; P = .049). The 30-day S/D and S/D/M rates were similar between male and female patients (S/D, 2.7% male vs 1.6% female [P = .34]; S/D/M, 3.6% male vs 2.6% female [P = .41]), which did not differ when stratified by symptom status. Secondary outcomes did not differ by sex, including stroke rates at 30 days (2.2% male vs 1.6% female; P = .80), nor were differences seen with stratification by symptom status. Univariate analysis demonstrated that history of a prior ipsilateral stroke was associated with increased odds of S/D (odds ratio [OR], 4.19; P = .001) and S/D/M (OR, 2.78; P = .01), as was symptomatic presentation with increased odds for S/D (OR, 2.78; P = .02). Conclusions: Prospective TCAR trial data demonstrate exceptionally low rates of S/D/MI, which do not differ by patient sex. Competing Interests: Disclosures P.A.S. served as a national Co-Principal Investigator for ROADSTER 2 without remuneration. Consultant for Silk Road Medical, Surmodics, Philips, Boston Scientific, Medtronic, Cagent, and LimFlow. C.J.K. served as a national Co-Principal Investigator for ROADSTER 1. V.S.K. served as a national Co-Principal Investigator for ROADSTER 2 without remuneration. (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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