Stenting And Aggressive Medical Management For Preventing Recurrent Stroke In Intracranial Stenosis Trial Research Articles

Relationship Between Vascular Risk Factors and Location of Intracranial Atherosclerosis in the SAMMPRIS Trial

Background: Previous studies have reported that different locations of intracranial atherosclerosis (ICAS) are associated with different demographic features and vascular risk factors. We aimed to examine this observation in the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial population. Methods: SAMMPRIS was a randomized controlled trial that enrolled 451 patients with recent transient ischemic attack or stroke-related due to severe (70%-99%) stenosis of a major intracranial artery. We compared the baseline demographic features and vascular risk factors between the symptomatic artery locations. Wilcoxon test was used to compare continuous variables, and chi-square test was used for categorical variables. Results: Of 449 patients included in the analysis; 289 (64.4%) had ICAS in the anterior circulation and 160 (35.6%) in the posterior circulation. Features that were significantly different between patients with anterior versus posterior ICAS were: median age (58.3 years versus 64.0 years, P < .001), males/females (52.9%/47.1% versus 74.4%/25.6% P < .001), white/black (66.8%/26.6% versus 79.4%/16.9%, P = .02), and history of hyperlipidemia (85.5% versus 92.5%, P = .03). Conclusions: The observed differences in the distribution of demographic characteristics and vascular risk factors depending on the location of symptomatic ICAS suggest the possibility of different underlying pathological processes involved in the formation of atherosclerotic plaques in different locations.

Abstract WMP47: Poor Risk Factor Control and Lower Levels of Physical Activity Predict Incident Major Cardiovascular Events in Patients With Symptomatic Vertebrobasilar Disease: A Post-Hoc Analysis of the SAMMPRIS Trial

Background: Symptomatic vertebrobasilar (VB) atherosclerotic disease is associated with a high risk of recurrent stroke despite optimal medical therapy. Objective: In this study, we aim to examine the prognosis and associations between risk factors and recurrent major cardiovascular events (MACE) in patients with symptomatic VB stenosis randomized in the medical arm of the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) study. Methods: Data from subjects in the medical arm of the SAMMPRIS trial with an infarct in the territory of vertebral or basilar arteries (n= 73) were analyzed. The primary outcome was MACE: defined as stroke, myocardial infarction, or other cardiovascular death during follow up. Mean risk factor values were compared between subjects who met the primary outcome at 2 years versus those who did not, using T-tests and χ2 tests. Results: Among 73 patients with VB stenosis randomized to medical treatment, 18 patients (24.6%) had recurrent MACE over a mean follow up of 2.8 years. This was significantly less than the rate of MACE in those with VB enrolled in the WASID trial (9.7 per 100-patient years vs. 20.9 per 100-patient years, p&lt;0.01). Predictors of MACE at 2 years were increased triglyceride level (adjusted OR per 50 units increase in triglyceride 1.94, 95% CI 1.15-3.28) and increased HbA1c level (adjusted OR per 1 unit increase in HbA1c 2.07, 95% CI 0.97-4.45), and lower physical activity status measured by PACE (out of target defined by PACE ≤ 4: moderate activity &lt; 5 days per week or intense activity &lt; 3 days per week) (2.5 ± 1.0 vs. 3.3 ± 1.8, p = 0.028) (Table). Conclusions: In patients with symptomatic VB disease, improvement of medical treatment over time led to a reduction in cardiovascular event rates but this risk remains elevated as nearly 1 in 5 patients had MACE within 2 years. Further risk factor optimization and lifestyle changes are needed to reduce the rates of MACE in this patient population.

Impact of Baseline Features and Risk Factor Control on Cognitive Function in the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis Trial

Background: Cerebrovascular disease is an important cause of cognitive impairment. The aim of this study is to report the relationship between cognitive function and risk factors at baseline and during follow-up in the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial. Methods: Subjects in the SAMMPRIS trial were included in this study. In order to have an assessment of cognitive function independent of stroke, patients with a stroke as a qualifying event whose deficits included aphasia or neglect were excluded from these analyses as were those with a cerebrovascular event during follow-up. The Montreal Cognitive Assessment (MoCA) score was used to assess cognitive impairment at baseline, 4 months, 12 months and closeout. Cognitive impairment was defined as MoCA < 26. A multivariate analysis was performed to determine what risk factors were independent predictors of cognitive function at baseline, 12 months and closeout. Among patients randomized to aggressive medical management only, the percentage of patients with cognitive impairment was compared between patients in versus out of target for each risk factor at 12 months and closeout. Results: Of the 451 patients in SAMMPRIS, 371 patients met the inclusion criteria. MoCA < 26 was present in 55% at baseline. Older age and physical inactivity were associated with cognitive impairment at baseline. Older age, non-white race, lower baseline body mass index, and baseline cognitive impairment were associated with cognitive impairment at 12 months. In the aggressive medical management group, at 12 months, physical inactivity during follow-up was the strongest risk factor associated with cognitive impairment. Conclusion: Cognitive impairment is common in patients with severe symptomatic intracranial atherosclerosis. Physical inactivity at baseline and during follow-up is a strong predictor of cognitive impairment.

Factors Associated With Recurrent Ischemic Stroke in the Medical Group of the SAMMPRIS Trial.

The Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) Trial showed that aggressive medical therapy was more effective than stenting for preventing stroke in patients with symptomatic intracranial stenosis. However, 15% of patients in the medical group still experienced a primary end point during a median follow-up of 32.7 months. To determine baseline features that were associated with a high rate of a primary end point in the medical arm of the SAMMPRIS Trial. A post hoc analysis of patients in the medical arm only of the SAMMPRIS trial. Enrollment occurred between October 2008 and April 2013 and included 227 patients randomized to medical management alone. Baseline demographic features, vascular risk factors, qualifying event, brain imaging, and angiographic features were analyzed. Bivariate and multivariable proportional hazard regression modeling was performed to relate baseline features to the time until a primary end point. The post hoc analysis was conducted from November 2014 to June 2015. The SAMMPRIS Trial compared stenting with aggressive medical management in patients with a stroke or transient ischemic attack attributed to 70% to 99% stenosis of a major intracranial artery. The primary outcome was any of the following: stroke or death within 30 days of enrollment, ischemic stroke in the territory of the symptomatic intracranial artery beyond 30 days after enrollment, or any stroke or death within 30 days after stenting a patient in the medical group during follow-up. A total of 227 patients were included in the study, 82 of whom were female, and the mean (SD) age was 59.5 (11.8) years. Being female (hazard ratio [HR], 1.9; 95% CI, 0.96-3.7), having diabetes mellitus (HR, 1.8; 95% CI, 0.9-3.5), not taking a statin at enrollment (HR, 2.6; 95% CI, 1.2-5.7), stroke as the qualifying event (HR, 2.5; 95% CI, 1.03-6.0), Rankin grade of 1 or greater (HR, 2.3; 95% CI, 0.9-5.5), old infarct in the territory of the stenotic artery (HR, 2.6; 95% CI, 1.3-5.1), and greater than 80% stenosis (HR, 1.9; 95% CI, 0.9-3.7) were associated (P < .10) with higher risk on bivariate analysis. Factors that were significantly associated with a primary end point on multivariable analyses were old infarct in the territory (HR, 2.6; 95% CI, 1.3-5.3; P = .006), stroke as the qualifying event (HR, 3.0; 95% CI, 1.1-7.7; P = .03), and no statin use at enrollment (HR, 2.4; 95% CI, 1.1-5.2; P = .03). Old infarct in the territory of the stenosis, new stroke presentation, and absence of statin use at enrollment were independently associated with high rates of the primary end point in the medical group in the SAMMPRIS Trial. These features may be useful for selecting high-risk patients for future clinical trials evaluating alternative therapies for intracranial stenosis. clinicaltrials.gov Identifier: NCT00576693.

Abstract TP442: Baseline Cognitive Impairment and Associated Risk Factors in Patients with Intracranial Stenosis in the SAMMPRIS Trial

Background and Purpose: Cognitive impairment is an important outcome in stroke prevention trials. The Montreal Cognitive Assessment (MoCA) score is a cognitive measure used in the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial due to its sensitivity in detecting cognitive impairment in stroke patients. We sought to determine the prevalence of low baseline MoCA scores and the baseline risk factors associated with lower MoCA scores in SAMMPRIS patients. Methods: The main entrance criteria in SAMMPRIS were a TIA or non-disabling stroke within 30 days prior to enrollment attributed to 70-99% intracranial atherosclerosis. Patients with stroke as the qualifying event who had an NIH Stroke Score indicating aphasia or neglect were excluded from these analyses. Low MoCA score was defined as &lt;26, the standard value that has 90% sensitivity for detecting mild cognitive impairment. Baseline demographic, medical history, laboratory, and neuroimaging characteristics were compared between patients with low vs. normal MoCA scores in univariate and multivariate analyses. Results: The prevalence of low baseline MoCA scores was 207/377 (55%). Baseline features associated with low MoCA scores in the univariate analyses are shown in Table 1. In the multivariate analyses, older age (p&lt;0.0001) and physical inactivity (p=0.0166) were associated with low MoCA scores. MoCA score was not related to other vascular risk factors, severity of stenosis, prior stroke, or white matter lesions on CT or MRI. Conclusions: SAMMPRIS patients had a high prevalence of cognitive impairment at baseline, which was not explained by the presence of vascular risk factors, such as hypertension and hypercholesterolemia. This finding suggests that cognitive impairment may be an important source of potential disability in patients with intracranial stenosis.

E-050 Stenting after SAMMPRIS: the case for VBI

Intracranial atherosclerotic disease (ICAD) accounts for 10% of ischemic strokes. The Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) proposed an expansive indication for intracranial...

Do Not Throw the Baby Out with the Bathwater …

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