Safety of Carotid Revascularization in Patients With a History of Coronary Heart Disease.

Background and Purpose- We investigated whether procedural stroke or death risk of carotid artery stenting (CAS) compared with carotid endarterectomy (CEA) is different in patients with and without history of coronary heart disease (CHD) and whether the treatment-specific impact of age differs. Methods- We combined individual patient data of 4754 patients with symptomatic carotid stenosis from 4 randomized trials (EVA-3S [Endarterectomy Versus Angioplasty in Patients With Symptomatic Severe Carotid Stenosis], SPACE [Stent-Protected Angioplasty Versus Carotid Endarterectomy], ICSS [International Carotid Stenting Study], and CREST [Carotid Revascularization Endarterectomy Versus Stenting Trial]). Procedural risk was defined as any stroke or death ≤30 days after treatment. We compared procedural risk between both treatments with Cox regression analysis, stratified by history of CHD and age (<70, 70-74, ≥75 years). History of CHD included myocardial infarction, angina, or coronary revascularization. Results- One thousand two hundred ninety-three (28%) patients had history of CHD. Procedural stroke or death risk was higher in patients with history of CHD. Procedural risk in patients treated with CAS compared with CEA was consistent in patients with history of CHD (8.3% versus 4.6%; hazard ratio [HR], 1.96; 95% CI, 0.67-5.73) and in those without (6.9% versus 3.6%; HR, 1.93; 95% CI, 1.40-2.65; Pinteraction=0.89). In patients with history of CHD, procedural risk was significantly higher after CAS compared with CEA in patients aged ≥75 (CAS-to-CEA HR, 2.78; 95% CI, 1.32-5.85), but not in patients aged <70 (HR, 1.71; 95% CI, 0.79-3.71) and 70 to 74 years (HR, 1.09; 95% CI, 0.45-2.65). In contrast, in patients without history of CHD, procedural risk after CAS was higher in patients aged 70 to 74 (HR, 3.62; 95% CI, 1.80-7.29) and ≥75 years (HR, 2.64; 95% CI, 1.52-4.59), but equal in patients aged <70 years (HR, 1.05; 95% CI, 0.63-1.73; 3-way Pinteraction=0.09). Conclusions- History of CHD does not modify procedural stroke or death risk of CAS compared with CEA. CAS might be as safe as CEA in patients with history of CHD aged <75 years, whereas for patients without history of CHD, risk after CAS compared with CEA was only equal in those aged <70 years.

Prediction Models for Clinical Outcome After a Carotid Revascularization Procedure.

Background and Purpose- Prediction models may help physicians to stratify patients with high and low risk for periprocedural complications or long-term stroke risk after carotid artery stenting or carotid endarterectomy. We aimed to evaluate external performance of previously published prediction models for short- and long-term outcome after carotid revascularization in patients with symptomatic carotid artery stenosis. Methods- From a literature review, we selected all prediction models that used only readily available patient characteristics known before procedure initiation. Follow-up data from 2184 carotid artery stenting and 2261 carotid endarterectomy patients from 4 randomized trials (EVA-3S [Endarterectomy Versus Angioplasty in Patients With Symptomatic Severe Carotid Stenosis], SPACE [Stent-Protected Angioplasty Versus Carotid Endarterectomy], ICSS [International Carotid Stenting Study], and CREST [Carotid Revascularization Endarterectomy Versus Stenting Trial]) were used to validate 23 short-term outcome models to estimate stroke or death risk ≤30 days after the procedure and the original outcome measure for which the model was developed. Additionally, we validated 7 long-term outcome models for the original outcome measure. Predictive performance of the models was assessed with C statistics and calibration plots. Results- Stroke or death ≤30 days after the procedure occurred in 158 (7.2%) patients after carotid artery stenting and in 84 (3.7%) patients after carotid endarterectomy. Most models for short-term outcome after carotid artery stenting (n=4) or carotid endarterectomy (n=19) had poor discriminative performance (C statistics ranging from 0.49-0.64) and poor calibration with small absolute risk differences between the lowest and highest risk groups and overestimation of risk in the highest risk groups. Long-term outcome models (n=7) had a slightly better performance with C statistics ranging from 0.59 to 0.67 and reasonable calibration. Conclusions- Current models did not reliably predict outcome after carotid revascularization in a trial population of patients with symptomatic carotid stenosis. In particular, prediction of short-term outcome seemed to be difficult. Further external validation of existing prediction models or development of new prediction models is needed before such models can be used to support treatment decisions in individual patients.

Validity of the Utrecht scale for evaluation of rehabilitation-participation restrictions scale in a hospital-based stroke population 3 months after stroke.

BACKGROUND: The Utrecht Scale for Evaluation of Rehabilitation-Participation Restrictions scale (USER-P-R) is a promising patient-reported outcome measure, but has currently not been validated in a hospital-based stroke population. OBJECTIVE: To examine psychometric properties of the USER-P-R in a hospital-based stroke population 3 months after stroke onset. METHODS: Cross-sectional study including 359 individuals with stroke recruited through 6 Dutch hospitals. The USER-P-R, EuroQol 5-dimensional 5-level questionnaire (EQ-5D-5 L), Patient Reported Outcomes Measurement Information System 10-Question Global Health Short Form (PROMIS-10), modified Rankin Scale (mRS) and two items on perceived decrease in health and activities post-stroke were administered in a telephone interview 3 months after stroke. The internal consistency, distribution, floor/ceiling effects, convergent validity and discriminant ability of the USER-P-R were calculated. RESULTS: Of all participants, 96.9% were living at home and 50.9% experienced no or minimal disabilities (mRS 0-1). The USER-P-R showed high internal consistency (α = 0.90) and a non-normal left-skewed distribution with a ceiling effect (21.4% maximum scores). A substantial proportion of participants with minimal disabilities (mRS 1) experienced restrictions on USER-P-R items (range 11.9-48.5%). The USER-P-R correlated strongly with the EQ-5D-5 L, PROMIS-10 and mRS. The USER-P-R showed excellent discriminant ability in more severely affected individuals with stroke, whereas its discriminant ability in less affected individuals was moderate. CONCLUSIONS: The USER-P-R shows good measurement properties and provides additional patient-reported information, proving its usefulness as an instrument to evaluate participation after 3 months in a hospital-based stroke population.

Nonfocal transient neurological attacks in patients with carotid artery occlusion.

INTRODUCTION: Nonfocal transient neurological attacks (TNAs) are episodes with atypical, nonlocalizing cerebral symptoms. We examined the prevalence of nonfocal TNAs, in patients with and without carotid artery occlusion (CAO). METHODS: We included 67 patients with CAO and 62 patients without CAO. In both groups, patients had a history of transient ischemic attack (TIA) or nondisabling ischemic stroke in the anterior circulation that had occurred >6 months before inclusion. Patients without CAO did not have ipsilateral or contralateral carotid artery stenosis of ≥50%. All patients were interviewed with a standardized questionnaire on the occurrence of nonfocal TNA symptoms during the preceding six months. We calculated risk ratios (RRs) with 95% confidence intervals (CIs) for the occurrence of ≥1 and ≥2 different nonfocal TNAs after adjustments for age, sex, systolic blood pressure and time interval between most recent TIA or ischemic stroke and administration of the questionnaire. RESULTS: Forty-three of all patients (33%) had had one or more nonfocal TNAs in the preceding six months. Nonrotatory dizziness (24%) was reported most often. The prevalence of ≥1 nonfocal TNAs was not significantly different between patients with and without CAO (39% vs. 27%; adjusted RR 1.47, 95% CI 0.83-2.61), but the prevalence of ≥2 or more different nonfocal TNAs was higher in patients with CAO (16% vs. 3%; adjusted RR 4.77, 95% CI 1.20-18.98). In patients with CAO who also had a contralateral carotid or vertebral artery steno-occlusion, nonfocal TNAs occurred more often than in patients without any carotid or vertebral artery steno-occlusion (46% vs. 27%; adjusted RR 2.22, 95% CI 1.08-4.60 for ≥1 and 21% vs. 3%; adjusted RR 8.27, 95% CI 1.83-37.32 for ≥2 nonfocal TNAs). CONCLUSIONS: Patients with CAO more often experienced multiple nonfocal TNAs than patients without CAO.

Prediction models for clinical outcome after a carotid revascularisation procedure: A systematic review.

INTRODUCTION: Prediction models for clinical outcome after carotid artery stenting or carotid endarterectomy could aid physicians in estimating peri- and postprocedural risks in individual patients. We aimed to identify existing prediction models for short- and long-term outcome after carotid artery stenting or carotid endarterectomy in patients with symptomatic or asymptomatic carotid stenosis, and to summarise their most important predictors and predictive performance. PATIENTS AND METHODS: We performed a systematic literature search for studies that developed a prediction model or risk score published until 22 December 2016. Eligible prediction models had to predict the risk of vascular events with at least one patient characteristic. RESULTS: We identified 37 studies that developed 46 prediction models. Thirty-four (74%) models were developed in carotid endarterectomy patients; 27 of these (59%) predicted short-term (in-hospital or within 30 days) risk. Most commonly predicted outcome was stroke or death (n = 12; 26%). Age (n = 31; 67%), diabetes mellitus (n = 21; 46%), heart failure (n = 16; 35%), and contralateral carotid stenosis ≥50% or occlusion (n = 16; 35%) were most commonly used as predictors. For 25 models (54%), it was unclear how missing data were handled; a complete case analysis was performed in 15 (33%) of the remaining 21 models. Twenty-eight (61%) models reported the full regression formula or risk score with risk classification. Twenty-one (46%) models were validated internally and 12 (26%) externally. Discriminative performance (c-statistic) ranged from 0.66 to 0.94 for models after carotid artery stenting and from 0.58 to 0.74 for models after carotid endarterectomy. The c-statistic ranged from 0.55 to 0.72 for the external validations. DISCUSSION: Age, diabetes mellitus, heart failure, and contralateral carotid stenosis ≥50% or occlusion were most often used as predictors in all models. Discriminative performance (c-statistic) was higher for prediction models after carotid artery stenting than after carotid endarterectomy. CONCLUSION: The clinical usefulness of most prediction models for short- or long-term outcome after carotid artery stenting or carotid endarterectomy remains unclear because of incomplete reporting, methodological limitations, and lack of external validation.

Body mass index and outcome after revascularization for symptomatic carotid artery stenosis.

OBJECTIVE: To determine whether the obesity paradox exists in patients who undergo carotid artery stenting (CAS) or carotid endarterectomy (CEA) for symptomatic carotid artery stenosis. METHODS: We combined individual patient data from 2 randomized trials (Endarterectomy vs Angioplasty in Patients with Symptomatic Severe Carotid Stenosis and Stent-Protected Angioplasty vs Carotid Endarterectomy) and 3 centers in a third trial (International Carotid Stenting Study). Baseline body mass index (BMI) was available for 1,969 patients and classified into 4 groups: <20, 20-<25, 25-<30, and ≥30 kg/m2. Primary outcome was stroke or death, investigated separately for the periprocedural and postprocedural period (≤120 days/>120 days after randomization). This outcome was compared between different BMI strata in CAS and CEA patients separately, and in the total group. We performed intention-to-treat multivariable Cox regression analyses. RESULTS: Median follow-up was 2.0 years. Stroke or death occurred in 159 patients in the periprocedural (cumulative risk 8.1%) and in 270 patients in the postprocedural period (rate 4.8/100 person-years). BMI did not affect periprocedural risk of stroke or death for patients assigned to CAS (ptrend = 0.39) or CEA (ptrend = 0.77) or for the total group (ptrend = 0.48). Within the total group, patients with BMI 25-<30 had lower postprocedural risk of stroke or death than patients with BMI 20-<25 (BMI 25-<30 vs BMI 20-<25; hazard ratio 0.72; 95% confidence interval 0.55-0.94). CONCLUSIONS: BMI is not associated with periprocedural risk of stroke or death; however, BMI 25-<30 is associated with lower postprocedural risk than BMI 20-<25. These observations were similar for CAS and CEA.

Transient monocular blindness and the risk of vascular complications according to subtype: a prospective cohort study.

Patients with transient monocular blindness (TMB) can present with many different symptoms, and diagnosis is usually based on the history alone. In this study, we assessed the risk of vascular complications according to different characteristics of TMB. We prospectively studied 341 consecutive patients with TMB. All patients were interviewed by a single investigator with a standardized questionnaire; reported symptoms were classified into predefined categories. We performed Cox regression analyses with adjustment for baseline vascular risk factors. During a mean follow-up of 4.0 years, the primary outcome event of vascular death, stroke, myocardial infarction, or retinal infarction occurred in 60 patients (annual incidence 4.4 %, 95 % confidence interval (CI) 3.4-5.7). An ipsilateral ischemic stroke occurred in 14 patients; an ipsilateral retinal infarct in six. Characteristics of TMB independently associated with subsequent vascular events were: involvement of only the peripheral part of the visual field (hazard ratio (HR) 6.5, 95 % CI 3.0-14.1), constricting onset of loss of vision (HR 3.5, 95 % CI 1.0-12.1), downward onset of loss of vision (HR 1.9, 95 % CI 1.0-3.5), upward resolution of loss of vision (HR 2.0, 95 % CI 1.0-4.0), and the occurrence of more than three attacks (HR 1.7, 95 % CI 1.0-2.9). We could not identify characteristics of TMB that predicted a low risk of vascular complications. In conclusion, careful recording the features of the attack in patients with TMB can provide important information about the risk of future vascular events.