IMPORTANCE Hyperglycemia during acute ischemic stroke is common and is associated with worse outcomes. The efficacy of intensive treatment of hyperglycemia in this setting remains unknown. OBJECTIVES To determine the efficacy of intensive treatment of hyperglycemia during acute ischemic stroke. DESIGN, SETTING, AND PARTICIPANTS The Stroke Hyperglycemia Insulin Network Effort (SHINE) randomized clinical trial included adult patients with hyperglycemia (glucose concentration of >110 mg/dL if had diabetes or Ն150 mg/dL if did not have diabetes) and acute ischemic stroke who were enrolled within 12 hours from stroke onset at 63 US sites between April 2012 and August 2018; follow-up ended in November 2018. The trial included 1151 patients who met eligibility criteria. INTERVENTIONS Patients were randomized to receive continuous intravenous insulin using a computerized decision support tool (target blood glucose concentration of 80-130 mg/dL [4.4-7.2 mmol/L]; intensive treatment group: n = 581) or insulin on a sliding scale that was administered subcutaneously (target blood glucose concentration of 80-179 mg/dL [4.4-9.9 mmol/L]; standard treatment group: n = 570) for up to 72 hours. MAIN OUTCOMES AND MEASURES The primary efficacy outcome was the proportion of patients with a favorable outcome based on the 90-day modified Rankin Scale score (a global stroke disability scale ranging from 0 [no symptoms or completely recovered] to 6 [death]) that was adjusted for baseline stroke severity. RESULTS Among 1151 patients who were randomized (mean age, 66 years [SD, 13.1 years]; 524 [46%] women, 923 [80%] with diabetes), 1118 (97%) completed the trial. Enrollment was stopped for futilitybasedonprespecifiedinterimanalysiscriteria.Duringtreatment,themeanbloodglucoselevel was 118 mg/dL (6.6 mmol/L) in the intensive treatment group and 179 mg/dL (9.9 mmol/L) in the standard treatment group. A favorable outcome occurred in 119 of 581 patients (20.5%) in the intensive treatment group and in 123 of 570 patients (21.6%) in the standard treatment group (adjusted relative risk, 0.97 [95% CI, 0.87 to 1.08], P = .55; unadjusted risk difference, −0.83% [95% CI, −5.72% to 4.06%]). Treatment was stopped early for hypoglycemia or other adverse events in 65 of 581 patients (11.2%) in the intensive treatment group and in 18 of 570 patients (3.2%) in the standard treatment group. Severe hypoglycemia occurred only among patients in the intensive treatment group (15/581 [2.6%]; risk difference, 2.58% [95% CI, 1.29% to 3.87%]). CONCLUSIONS AND RELEVANCE Among patients with acute ischemic stroke and hyperglycemia, treatment with intensive vs standard glucose control for up to 72 hours did not result in a significant difference in favorable functional outcome at 90 days. These findings do not support using intensive glucose control in this setting.
Rationale Trials conducted decades ago demonstrated that carotid endarterectomy (CEA) by skilled surgeons reduced stroke risk in asymptomatic patients. Developments in carotid stenting (CAS) and improvements in medical prevention of stroke caused by atherothrombotic disease challenge understanding of the benefits of revascularization. Aim CREST-2 will test whether CEA or CAS plus contemporary intensive medical therapy (IMM) is superior to IMM alone in the primary prevention of stroke in patients with high-grade asymptomatic carotid stenosis (ACS). Methods and design CREST-2 is two multicenter randomized trials of revascularization plus IMM versus IMM alone. One trial randomizes patients to CEA plus IMM versus IMM alone; the other, to CAS plus IMM versus IMM alone. The risk factor targets of centrally directed IMM are LDL cholesterol <70 mg/dl and systolic blood pressure <140 mmHg. Study outcomes The primary outcome is the composite of stroke and death within 44 days following randomization and stroke ipsilateral to the target vessel thereafter, up to 4 years. Change in cognition and differences in major and minor stroke are secondary outcomes. Sample size Enrollment of 1240 patients in each trial provides 85% power to detect a treatment difference if the event rate in the IMM alone arm is 4.8% higher or 2.8% lower than an anticipated 3.6% rate in the revascularization arm. Discussion Management of ACS requires contemporary randomized trials to address whether CEA or CAS plus IMM is superior in preventing stroke beyond IMM alone. Whether CEA or CAS has favorable effects on cognition will also be tested.
Background and Purpose-Warfarin reduces stroke risk by approximately 60% in patients with atrial fibrillation (AF).Differences in awareness and treatment of AF may contribute to racial and geographic disparities in stroke mortality.The objective was to examine predictors of awareness of the diagnosis of AF and treatment with warfarin. Methods-REasons for Geographic and Racial Differences in Stroke (REGARDS) is a national, population-based, longitudinal study of 30 239 blacks and whites Ն45 years old with oversampling from blacks and the southeastern stroke belt states. Participants were enrolled January 2003 to October 2007. Data were collected using telephone interview, in-home evaluation, and self-administered questionnaires. The main variable of awareness of AF was defined by a positive answer to "Has a doctor or other health professional ever told you that you had atrial fibrillation?" and whether there was evidence of treatment on the basis of an in-home medications inventory. Results-From baseline electrocardiograms, 432 individuals (88 black and 344 white) had AF. Of these, 88% (360 of 409) had at least 1 additional CHADS 2 stroke risk factor and 60% (258 of 432) were aware of their AF. The odds of blacks being aware of their AF were one third that of whites (ORϭ0.32; 95% CI: 0.20 to 0.52). Among those aware, the odds of blacks being treated with warfarin were only one fourth as great as whites (ORϭ0.28; 0.13 to 0.60). Conclusion-Blacks were less likely than whites to be aware of having AF or to be treated with warfarin. Potential reasons for the racial disparity in warfarin treatment warrant further investigation. (Stroke. 2010;41:581-587.)
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