Health-related quality of life after carotid stenting versus carotid endarterectomy: results from CREST (Carotid Revascularization Endarterectomy Versus Stenting Trial)

Abstract

Objectives: The purpose of this study was to compare health-related quality of life (HRQOL) outcomes in patients treated with carotid artery stenting (CAS) versus carotid endarterectomy (CEA).

Background: In CREST (Carotid Revascularization Endarterectomy versus Stenting Trial), the largest randomized trial of carotid revascularization to date, there was no significant difference in the primary composite endpoint, but rates of stroke and myocardial infarction (MI) differed between CAS and CEA. To help guide individualized clinical decision making, we compared HRQOL among patients enrolled in the CREST study. We also performed exploratory analyses to evaluate the association between periprocedural complications and HRQOL.

Methods: We measured HRQOL at baseline, and after 2 weeks, 1 month, and 1 year among 2,502 patients randomly assigned to either CAS or CEA in the CREST study. The HRQOL was assessed using the Medical Outcomes Study Short-Form 36 (SF-36) and 6 disease-specific scales designed to study HRQOL in patients undergoing carotid revascularization.

Results: At both 2 weeks and 1 month, CAS patients had better outcomes for multiple components of the SF-36, with large differences for role physical function, pain, and the physical component summary scale (all p < 0.01). On the disease-specific scales, CAS patients reported less difficulty with driving, eating/swallowing, neck pain, and headaches but more difficulty with walking and leg pain (all p < 0.05). However, by 1 year, there were no differences in any HRQOL measure between CAS and CEA. In the exploratory analyses, periprocedural stroke was associated with poorer 1-year HRQOL across all SF-36 domains, but periprocedural MI or cranial nerve palsy were not.

Conclusions: Among patients undergoing carotid revascularization, CAS is associated with better HRQOL during the early recovery period as compared with CEA-particularly with regard to physical limitations and pain-but these differences diminish over time and are not evident after 1 year. Although CAS and CEA are associated with similar overall HRQOL at 1 year, event-specific analyses confirm that stroke has a greater and more sustained impact on HRQOL than MI. (Carotid Revascularization Endarterectomy versus Stenting Trial [CREST]; NCT00004732)

Conflict of interest statement

Conflicts of Interest: Dr. Cohen has received research support from Boston Scientific, Abbott Vascular, Medtronic, Edwards Lifesciences, MedRad, Merck/Schering-Plough, and Eli Lilly-Daiichi Sankyo; he reports serving as a consultant to Schering-Plough, Eli Lilly, Medtronic, and Cordis; and he has served on the speakers’ bureau for Eli Lilly and The Medicines Company. Dr. Stolker has served on the speakers’ bureau for AstraZeneca. Dr. Magnuson has received research support from Eli-Lilly-Daiichi Sankyo, Sanofi-Aventis, and Bristol Myers Squibb; and she has received honoraria from Sanofi-Aventis. Dr. Aronow has served on the speakers’ bureau/advisory board for Medtronic. Dr. Goldstein has served as consultant/advisory board member for Abbott, ACT-1 Trial Clinical Oversight Committee. Dr. Roubin has received royalties from Abbott Vascular, Inc. and Cook, Inc. Dr. Howard has served as consultant/advisory board member for Bayer Healthcare and is a member of the ARRIVE Executive Committee. The other authors have no conflicts to report regarding this analysis.

Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Figures

Figure 1. Completeness of Data

Available health status data in patients randomized to CAS versus CEA. Percentages listed above each bar indicate the proportion of surviving patients with health status scores available at that timepoint. CAS indicates carotid artery stent; CEA, carotid endarterectomy.

Figure 2. Generic Health Status During Follow-Up

Trend in SF-36 scores from baseline to 1-year. Higher scores indicate better quality-of-life; significant differences in scores (p≤0.05) were noted in 5 of 8 subscales and the physical component summary scale at the 2-week follow-up visit, and in 3 of 8 subscales and the physical component summary scale at the 1-month follow-up visit. All differences between groups had resolved by 1-year. Plotted values at each timepoint represent least-squares means and associated 95% confidence intervals derived from the analysis of covariance. CAS indicates carotid artery stenting; CEA, carotid endarterectomy; SF-36, Medical Outcomes Study Short-Form 36.

Figure 3. Disease-Specific Functional Limitations

Trend in modified Likert scores from baseline to 1-year for (A) difficulty eating or swallowing, (B) difficulty walking, and (C) difficulty driving. CAS indicated carotid artery stenting; CEA, carotid endarterectomy.

Figure 4. Disease-Specific Pain Scales

Trend in modified Likert scores from baseline to 1-year for (A) headaches, (B) neck pain, and (C) leg pain. CAS indicates carotid artery stenting; CEA, carotid endarterectomy.