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

@entity1 @entity64 @entity932 @entity6 @entity63 @entity1188 @entity850 @entity204 @entity385
IMPORTANCE: The Stenting and Aggressive Medical Management for Preventing Recurrent @entity64 (SAMMPRIS) Trial showed that aggressive medical therapy was more effective than stenting for preventing @entity64 in @entity1 with symptomatic @entity932 . However, 15% of @entity1 in the medical group still experienced a primary end point during a median follow-up of 32.7 months. OBJECTIVE: To determine baseline features that were associated with a high rate of a primary end point in the medical arm of the SAMMPRIS Trial. DESIGN, SETTING, AND @entity1 : A post hoc analysis of @entity1 in the medical arm only of the SAMMPRIS trial. Enrollment occurred between October 2008 and April 2013 and included 227 @entity1 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. INTERVENTIONS: The SAMMPRIS Trial compared stenting with aggressive medical management in @entity1 with a @entity64 or transient @entity63 attack attributed to 70% to 99% @entity850 of a major intracranial artery. MAIN OUTCOMES AND MEASURES: The primary outcome was any of the following: @entity64 or @entity204 within 30 days of enrollment, @entity385 in the territory of the symptomatic intracranial artery beyond 30 days after enrollment, or any @entity64 or @entity204 within 30 days after stenting a @entity1 in the medical group during follow-up. RESULTS: A total of 227 @entity1 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 @entity6 (HR, 1.8; 95% CI, 0.9-3.5), not taking a statin at enrollment (HR, 2.6; 95% CI, 1.2-5.7), @entity64 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 @entity1188 (HR, 2.6; 95% CI, 1.3-5.1), and greater than 80% @entity850 (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 @entity1188 in the territory (HR, 2.6; 95% CI, 1.3-5.3; P   =   .006), @entity64 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). CONCLUSIONS AND RELEVANCE: Old @entity1188 in the territory of the @entity850 , new @entity64 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 @entity1 for future clinical trials evaluating alternative therapies for @entity932 . TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00576693.
