Society for Vascular Surgery (SVS) Vascular Registry evaluation of comparative effectiveness of carotid revascularization procedures stratified by Medicare age

Washington University School of Medicine, St. Louis, Mo., USA.
Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter (Impact Factor: 3.02). 03/2012; 55(5):1313-20; discussion 1321. DOI: 10.1016/j.jvs.2011.11.128
Source: PubMed


Recent randomized controlled trials have shown that age significantly affects the outcome of carotid revascularization procedures. This study used data from the Society for Vascular Surgery Vascular Registry (VR) to report the influence of age on the comparative effectiveness of carotid endarterectomy (CEA) and carotid artery stenting (CAS).
VR collects provider-reported data on patients using a Web-based database. Patients were stratified by age and symptoms. The primary end point was the composite outcome of death, stroke, or myocardial infarction (MI) at 30 days.
As of December 7, 2010, there were 1347 CEA and 861 CAS patients aged < 65 years and 4169 CEA and 2536 CAS patients aged ≥ 65 years. CAS patients in both age groups were more likely to have a disease etiology of radiation or restenosis, be symptomatic, and have more cardiac comorbidities. In patients aged <65 years, the primary end point (5.23% CAS vs 3.56% CEA; P = .065) did not reach statistical significance. Subgroup analyses showed that CAS had a higher combined death/stroke/MI rate (4.44% vs 2.10%; P < .031) in asymptomatic patients but there was no difference in the symptomatic (6.00% vs 5.47%; P = .79) group. In patients aged ≥ 65 years, CEA had lower rates of death (0.91% vs 1.97%; P < .01), stroke (2.52% vs 4.89%; P < .01), and composite death/stroke/MI (4.27% vs 7.14%; P < .01). CEA in patients aged ≥ 65 years was associated with lower rates of the primary end point in symptomatic (5.27% vs 9.52%; P < .01) and asymptomatic (3.31% vs 5.27%; P < .01) subgroups. After risk adjustment, CAS patients aged ≥ 65 years were more likely to reach the primary end point.
Compared with CEA, CAS resulted in inferior 30-day outcomes in symptomatic and asymptomatic patients aged ≥ 65 years. These findings do not support the widespread use of CAS in patients aged ≥ 65 years.


Available from: Christopher T Kenwood, Jun 02, 2014
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    Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 12/2012; 56(6):1748-60. DOI:10.1016/j.jvs.2012.10.010 · 3.02 Impact Factor
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    ABSTRACT: Introduction: The largest randomized controlled trial that compared the efficacy of carotid endarterectomy (CEA) with carotid artery stenting (CAS) showed equivalent outcomes for the composite end point of postoperative stroke, myocardial infarction (MI), or death. However, CAS had a higher risk of postoperative stroke, and CEA had a higher risk of MI. We hypothesize that there is a differential association of postoperative stroke, compared with that of postoperative MI, with reduced long-term survival after carotid revascularization when compared with neither complication. Methods: The Vascular Study Group of New England database was used to identify all CEA and CAS procedures performed between 2003 and 2011. Patients were stratified according to whether they experienced an in-hospital postoperative stroke (minor or major), MI (troponin elevation, electrocardiographic changes, or clinical symptoms), or neither. Primary study end point was survival during the first year and the first 5 years postoperatively. Multivariable Cox proportional hazards models compared the magnitude of association of stroke and MI on survival. Results: Of 8315 patients, 81 (0.97%) experienced postoperative MI, and 63 (0.76%) experienced stroke. During the first year after operation, survival significantly differed among the three groups: neither, 96%; MI, 84%; stroke, 77% (log-rank P < .0001). After adjusting for confounders, survival after postoperative stroke (hazard ratio [HR], 6.6; 95% confidence interval [CI], 3.7-12; P < .0001) was nearly twofold less than that after postoperative MI (HR, 3.6; 95% CI, 2-6.8; P < .0001). During the first 5 years postoperatively, multivariable modeling showed postoperative stroke and postoperative MI remained independent predictors of decreased survival, but the magnitude of association was similar (HR, 2.7; 95% CI, 1.7-4.3 [P < .0001] vs HR, 2.8; 95% CI, 1.8-4.3 [P < .0001]). Conclusions: During the first year after operation, postoperative stroke conferred a twofold lower survival than that after postoperative MI. By 5 years after operation, these survival curves converged, and the survival disadvantage associated with stroke became similar to that of MI. These data suggest that different postoperative complications after carotid revascularization have different implications for patients, with decreased short-term survival in patients experiencing a postoperative stroke. These findings help to inform our interpretation of studies that have used a composite end point in order to evaluate the comparative effectiveness of revascularization strategies.
    Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 02/2013; 56(5). DOI:10.1016/j.jvs.2012.11.118 · 3.02 Impact Factor
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    ABSTRACT: The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) has been used to support the equivalence of carotid artery stenting (CAS) and carotid endarterectomy (CEA) in the treatment of carotid stenosis in both symptomatic and asymptomatic patients. This inclusion of two different forms of the disease decreased the power and significance of the CREST results and weakened the trial. Other flaws in CREST were the equal weighting of mostly minor myocardial infarctions (MIs) with strokes and death in the peri-procedural, composite 'end' point, but not in the 4-year, long-term 'end' point. Although CAS was associated with 50% fewer peri-procedural MIs compared with CEA, there were >2.5-fold more MIs after CAS than CEA at 4 years. The 4-year MI rate, however, was not a component of the primary 'end' point. Additionally, although the initial CREST report indicated that there was no difference in the outcomes of CAS and CEA according to symptomatic status or sex, subsequent subgroup analyses showed that CAS was associated with significantly higher stroke and death rates than CEA in symptomatic patients, in females and in individuals ≥65 years of age. The present article will examine these and other flaws and the details of CREST's results derived from the trial's preplanned subanalyses to show why the claims that CREST demonstrates equivalence of the two therapeutic procedures are unjustified.
    European journal of vascular and endovascular surgery: the official journal of the European Society for Vascular Surgery 04/2013; 45(6). DOI:10.1016/j.ejvs.2013.03.014 · 2.49 Impact Factor
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