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When Is Carotid Angioplasty and Stenting the Cost-Effective Alternative for Revascularization of Symptomatic Carotid Stenosis? a Canadian Health System Perspective

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When Is Carotid Angioplasty and Stenting the Cost-Effective Alternative for Revascularization of Symptomatic Carotid Stenosis? a Canadian Health System Perspective ORIGINAL RESEARCH INTERVENTIONAL When Is Carotid Angioplasty and Stenting the Cost-Effective Alternative for Revascularization of Symptomatic Carotid Stenosis? A Canadian Health System Perspective M.A. Almekhlafi, M.D. Hill, S. Wiebe, M. Goyal, D. Yavin, J.H. Wong, and F.M. Clement EBM 1 ABSTRACT BACKGROUND AND PURPOSE: Carotid revascularization procedures can be complicated by stroke. Additional disability adds to the already high costs of the procedure. To weigh the cost and benefit, we estimated the cost-utility of carotid angioplasty and stenting compared with carotid endarterectomy among patients with symptomatic carotid stenosis, with special emphasis on scenario analyses that would yield carotid angioplasty and stenting as the cost-effective alternative relative to carotid endarterectomy. MATERIALS AND METHODS: A cost-utility analysis from the perspective of the health system payer was performed by using a Markov analytic model. Clinical estimates were based on a meta-analysis. The procedural costs were derived from a microcosting data base. The costs for hospitalization and rehabilitation of patients with stroke were based on a Canadian multicenter study. Utilities were based on a randomized controlled trial. RESULTS: In the base case analysis, carotid angioplasty and stenting were more expensive (incremental cost of $6107) and had a lower utility (Ϫ0.12 quality-adjusted life years) than carotid endarterectomy. The results are sensitive to changes in the risk of clinical events and the relative risk of death and stroke. Carotid angioplasty and stenting were more economically attractive among high-risk surgical patients. For carotid angioplasty and stenting to become the preferred option, their costs would need to fall from more than $7300 to $4350 or less and the risks of the periprocedural and annual minor strokes would have to be equivalent to that of carotid endarterectomy. CONCLUSIONS: In the base case analysis, carotid angioplasty and stenting were associated with higher costs and lower utility compared with carotid endarterectomy for patients with symptomatic carotid stenosis. Carotid angioplasty and stenting were cost-effective for patients with high surgical risk. ABBREVIATIONS: BURST ϭ Burden of Ischemic Stroke; CAS ϭ carotid angioplasty and stenting; CEA ϭ carotid endarterectomy; CREST ϭ Carotid Revascularization Endarterectomy versus Stenting Trial; EVA-3S ϭ Endarterectomy versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis; MI ϭ myocardial infarction; QALY ϭ quality-adjusted life years; SAPPHIRE ϭ Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy troke is a costly illness. Stroke prevention among patients with formed in Canada in 2005.3 Stroke is an uncommon but feared Ssymptomatic carotid stenosis requires carotid revasculariza- complication of carotid revascularization.4 Stroke is more com- tion. This can be done surgically as carotid endarterectomy mon after CAS, and though most of these periprocedural strokes are (CEA)1 or less invasively through carotid angioplasty and stent clinically minor, they contribute to the cumulative disability associ- 2 placement (CAS). Both are used in combination with optimal ated with the procedure.5 The largest randomized trial comparing medical therapy. Approximately 5000 CEA procedures were per- CAS versus CEA (the Carotid Revascularization Endarterectomy versus Stenting Trial [CREST]) concluded that the outcomes after CEA versus CAS were similar because a higher risk of myocardial Received April 19, 2013; accepted after revision May 29. infarction (MI) after CEA was balanced by a higher risk of stroke after From the Departments of Clinical Neurosciences (M.A.A., M.D.H., S.W., M.G., D.Y., J.H.W.), Medicine (M.D.H.), Community Health Sciences (M.D.H., S.W., F.M.C.), and CAS.2 Radiology (M.G., M.D.H.), Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta, Canada; and Department of Internal Medicine (M.A.A.), King Abdulaziz Increased costs of CAS due to the costs of devices and the University, Jeddah, Saudi Arabia. higher costs of stroke as a complication may be balanced by a Please address correspondence to Mohammed A. Almekhlafi, MD, MSc, FRCP(C), slightly longer length of stay after CEA.6-9 These outcomes have Foothills Medical Center, 1403 29th St NW, Calgary, Alberta, Canada T2N 2T9; 10,11 e-mail: malmekhlafi@kau.edu.sa different impacts on the patient’s quality of life. We sought to Indicates article with supplemental on-line tables. determine the cost-utility of CAS compared with CEA in symp- EBM 1 Evidence-Based Medicine Level 1. tomatic patients and to understand what circumstances make http://dx.doi.org/10.3174/ajnr.A3682 CAS a cost-effective procedure. AJNR Am J Neuroradiol 35:327–32 Feb 2014 www.ajnr.org 327 MATERIALS AND METHODS ties were discounted at 5% annually. Costs were inflated to 2012 The cost per quality-adjusted life years (QALY) gained with CAS costs by using the Canadian Consumer Price Index for health and compared with CEA in the treatment of patients with symptom- personal care.14 Decision analysis software (TreeAge Software, atic carotid stenosis was assessed. The perspective of the Canadian Williamstown, Massachusetts) was used to construct a Markov health care system payer was adopted. The costs and clinical out- model. The study was approved by the Conjoint Health Research comes were modeled by using a Markov process. A lifetime time Ethics Board at the University of Calgary. horizon was used12 to capture all relevant costs and benefits. Clinical Data Model The estimates of the clinical outcomes in the periprocedural (30- Figure 1 presents the model structure. Given the higher risk of day) period were pooled from the results of a recent meta-analy- adverse outcomes in the initial 30 days after CAS or CEA, the first sis,4 which included 12 major carotid revascularization trials en- 30-day outcomes were modeled separately from long-term out- rolling 6973 patients (Table 1). This meta-analysis did not comes. Patients who survive the initial period will be in 1 of 4 separately report the rates of periprocedural major and minor health states: healthy, major stroke, minor stroke, or MI. The costs strokes. Data from this recent meta-analysis were reanalyzed to and clinical outcomes were assessed at 1-year intervals. provide estimates of periprocedural major and minor strokes.4 All clinical outcomes were taken from published randomized tri- The long-term clinical outcomes in those who survived the als comparing CEA and CAS. Major stroke was defined as stroke that periprocedural period reported in included studies by Yavin et al4 results in disability interfering with independent living. Minor stroke were pooled to estimate the annual incidence of major stroke, was defined as stroke that causes no disability or causes a disability minor stroke, and death, excluding the first 30 days. The annual that does not interfere with independent living.13 Myocardial infarc- risk of each outcome was calculated by dividing the total number tion was defined as chest pain associated with electrocardiographic of patients with the outcome by the number of follow-up years changes or elevated cardiac enzymes. The healthy state described in- (excluding outcomes occurring in the first 30 days). dividuals who did not have stroke or MI or die following the carotid The risk of MI beyond the first 30 days was not reported in revascularization procedure. The healthy state included patients who major randomized trials of CAS versus CEA and therefore was might have had known transient complications not typically affect- assumed similar among patients undergoing either procedure. ing a durable quality of life, such as cranial nerve palsy following CEA Survival data beyond the follow-up of the clinical trials (Յ4 years or groin hematoma following CAS. of follow-up) were based on the study by Caro et al.15 The base case analysis simulated a cohort of patients at an Cost Data average age of 65 years with symptomatic carotid stenosis eligible for revascularization with either CAS or CEA. All costs and utili- Procedural Costs. Using microcosting data from the Calgary Health Zone, we selected a cohort of con- secutive patients with carotid stenosis who underwent carotid revascularization (2005–2007). Costs estimates reflected the direct costs incurred by the health sys- tem. Inpatient costing data include those for investigations and treatments. Investi- gation costs included laboratory, imag- ing, and cardiac investigations. Treat- ment costs included the operating room and angiography suite costs; nursing care; and medications, devices, and materials used. Human resources costs (including nurses, therapists, and social workers) were also captured. Physician claims for endarterectomy, stent placement, and an- esthesia were obtained from the Alberta Ministry of Health schedule of medical benefits. Hospitalization costs were cal- FIG 1. The Markov model structure. Table 1: Clinical estimates for the periprocedural and annual outcomes Periprocedural Risk (CI95) Annual Risk (CI95) Periprocedural OR (CI95) Annual OR (CI95)of Outcome after CEA after CEA of CAS vs CEA CAS vs CEA References Death 0.009 (0.008–0.01) 0.018 (0.016–0.02) 1.11 (0.82–1.40) 1.02 (0.94–1.10) 2,4,21,22,27,28 Major stroke 0.006 (0.005–0.008) 0.013 (0.012–0.015) 1.645 (0.89–2.1) 1.1 (0.58–2.10) Minor stroke 0.022 (0.019–0.025) 0.0515 (0.05–0.052) 1.91 (1.17–3.11) 1.3 (0.75–2.08) MI 0.018 (0.015–0.02) N/A 0.47 (0.38–0.56) N/A Note:—CI95 indicates
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