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Background and Purpose-National guidelines on carotid endarterectomy (CEA) for asymptomatic patients state that the procedure should be performed with a Յ3% risk of perioperative death or stroke. We developed and validated a multivariate model of risk of death or stroke within 30 days of CEA for asymptomatic disease and a related clinical prediction rule. Methods-We analyzed asymptomatic cases in a population-based cohort of CEAs performed in Medicare beneficiaries in New York State. Medical records were abstracted for sociodemographics, neurologic history, disease severity, diagnostic imaging data, comorbidities, and deaths and strokes within 30 days of surgery. We used multivariate logistic regression to identify independent predictors of perioperative death or stroke. The CEA-8 clinical risk score was derived from the final model. Results-Among the 6553 patients, the mean age was 74 years, 55% were male, 62% had coronary artery disease, and 22% had a history of distant stroke or transient ischemic attack. The perioperative rate of death or stroke was 3.0%. Multivariable predictors of perioperative events were female sex (odds ratio [OR]ϭ1.5; 95% CI, 1.1 to 1.9), nonwhite race (ORϭ1.8; 95% CI, 1.1 to 2.9), severe disability (ORϭ3.7; 95% CI, 1.8 to 7.7), congestive heart failure (ORϭ1.6; 95% CI, 1.1 to 2.4), coronary artery disease (ORϭ1.6; 95% CI, 1.2 to 2.2), valvular heart disease (ORϭ1.5; 95% CI, 1.1 to 2.3), a distant history of stroke or transient ischemic attack (ORϭ1.5; 95% CI, 1.1 to 2.0), and a nonoperated stenosis Ն50% (ORϭ1.8; 95% CI, 1.3 to 2.3). The CEA-8 risk score stratified patients with a predicted probability of death or stroke rate from 0.6% to 9.6%. Conclusions-Several sociodemographic, neurologic severity, and comorbidity factors predicted the risk of perioperative death or stroke in asymptomatic patients. The CEA-8 risk score can help clinicians calculate a predicted probability of complications for an individual patient to help inform the decision about revascularization. (Stroke. 2010;41:2786-2794.)

Background and Purpose: National AHA guidelines on carotid endarterectomy (CEA) for asymptomatic patients (Pts) stipulate that the long term benefit of surgery is dependent on having a ≤ 3% risk of perioperative death or stroke (D/S) due to the procedure. We developed and validated a multivariate model of risk of D/S within 30 days of CEA for asymptomatic disease and a clinical prediction rule based on the final model. Methods: We analyzed data from 6553 asymptomatic cases in the New York Carotid Artery Surgery (NYCAS) study, a population-based cohort of all Medicare beneficiaries having CEA in NY State from 1/98 to 6/99. Medical records were abstracted for: sociodemographics, neurological history, carotid imaging data, comorbidities, and D/S within 30 days. All events were adjudicated. Multivariate logistic regression with GEE was used to identify independent predictors of combined D/S. The final model was cross-validated with100 random splits. A CEA-8 Clinical Risk Score assigned 1 point to each risk factor except for disability which got 2 points. Results: The 6553 CEAs were performed by 435 surgeons in 157 hospitals. Mean age was 74 years, 3655 were male, 4152 had coronary artery disease (CAD), 873 valvular disease, 611 congestive heart failure (CHF), 1453 history of distant stroke or TIA, and 93 severe disability. Nearly all (6413) had 70-90% ipsilateral stenosis, and 2469 had ≥ 50% contralateral stenosis. The combined 30 day D/S rate was 3.0% (198 of 6553). Multivariable predictors of perioperative D/S were: female (OR, 1.5; 95% CI, 1.1-1.9), non-white (OR, 1.8; 1.1-2.9), severe disability (OR, 3.7; 1.8-7.7), CHF (OR, 1.6; 1.1-2.4), CAD (OR, 1.6; 1.2- 2.2), valvular heart disease (OR, 1.5; 1.1-2.3), distant history of stroke/TIA (OR, 1.5; 1.1- 2.0), and non-operated stenosis ≥50% (OR, 1.8; 1.3-2.3). The CEA-8 Risk Score stratified Pts from a D/S rate of 0.6% (3 of 509) to 10% (16 of 159). Conclusions: Several sociodemographic, neuroseverity, and comorbidity factors predicted risk of D/S in asymptomatic patients having CEA. A CEA-8 Risk Score of ≥ 4 identifies high risk Pts (predicted D/S rate of >7.5%) with 2.5 times the AHA guideline acceptable complication risk in asymptomatic Pts (≤ 3%).

Introduction: In randomized clinical trials(RCTs), carotid endarterectomy(CEA) reduced risk of death and stroke(D&S)compared to medical therapy(MedRx) in carefully selected patients and surgeons. We hypothesized the benefits of CEA among the elderly in real world practice would be more limited than in RCTs because patients are older and sicker, have shorter life expectancy, and have less experienced surgeons. Methods: We conducted a comparative effectiveness study of CEA v MedRx for carotid stenosis in the elderly using data from the Cardiovascular Health Study(CHS), a multicenter, community-based, prospective observational cohort study of participants(Pts) randomly selected from Medicare lists. CHS Pts had intensive evaluation of vascular events, risk factors, & comorbidities. Carotid stenosis was measured via ultrasound(US) at baseline, 5 and 10 years. D&S were ascertained though annual contact and all events were adjudicated. CEA was identified via annual contact and Medicare data. We assessed risk of D&S using Cox proportional hazards regression and propensity scores(PS) to adjust for factors associated with selection for CEA and risk of D&S. We focused on 487 Pts with ≥50% carotid stenosis by US and no prior CEA. Results: Overall, 89 Pts had CEA, and 398 MedRx during a median 12.1 years of follow-up. Half were men and 91% white. At baseline, mean age was 73.4 years, 76% had hypertension (HTN), 37% diabetes, 28% coronary heart disease(CHD), 7% prior stroke, and 8% TIA. CEA Pts were older and had more HTN, heart failure, atrial fibrillation, prior stroke, TIA, or CHD and worse self-rated health(v MedRx,all p<.05). In unadjusted analyses, rate of D&S was higher for CEA v MedRx at all time points: 30 days(7.8% v 0.2%), 5 years(39% v 27%), and 10 years(60% v 48%; Hazard Ratio(HR)=1.8; 95%CI: 1.3-2.3). The HR for CEA was unchanged(HR=1.8;CI: 1.2-2.6) with adjustment for PS, neurologic symptoms,and 13 other time varying covariates. Analyses assessing impact of CEA v MedRx on the adjusted, long term hazard of stroke alone also found worse outcomes for CEA(p<.05). Conclusions: Elderly CHS Pts with carotid stenosis managed with CEA (v MedRx) had higher long term adjusted risk of D&S and stroke alone. The benefits of CEA shown in younger, healthier patients in RCTs did not extend to the older, sicker CHS Pts, likely better reflecting the impact of CEA in real world practice. CEA in the elderly may result in worse outcomes compared to MedRx.