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Background and Purpose- Pilot trials suggest that glyceryl trinitrate (GTN; nitroglycerin) may improve outcome when administered early after stroke onset. Methods- We undertook a multicentre, paramedic-delivered, ambulance-based, prospective randomized, sham-controlled, blinded-end point trial in adults with presumed stroke within 4 hours of ictus. Participants received transdermal GTN (5 mg) or a sham dressing (1:1) in the ambulance and then daily for three days in hospital. The primary outcome was the 7-level modified Rankin Scale at 90 days assessed by central telephone treatment-blinded follow-up. This prespecified subgroup analysis focuses on participants with an intracerebral hemorrhage as their index event. Analyses are intention-to-treat. Results- Of 1149 participants with presumed stroke, 145 (13%; GTN, 74; sham, 71) had an intracerebral hemorrhage: time from onset to randomization median, 74 minutes (interquartile range, 45-110). By admission to hospital, blood pressure tended to be lower with GTN as compared with sham: mean, 4.4/3.5 mm Hg. The modified Rankin Scale score at 90 days was nonsignificantly higher in the GTN group: adjusted common odds ratio for poor outcome, 1.87 (95% CI, 0.98-3.57). A prespecified global analysis of 5 clinical outcomes (dependency, disability, cognition, quality of life, and mood) was worse with GTN; Mann-Whitney difference, 0.18 (95% CI, 0.01-0.35; Wei-Lachin test). GTN was associated with larger hematoma and growth, and more mass effect and midline shift on neuroimaging, and altered use of hospital resources. Death in hospital but not at day 90 was increased with GTN. There were no significant between-group differences in serious adverse events. Conclusions- Prehospital treatment with GTN worsened outcomes in patients with intracerebral hemorrhage. Since these results could relate to the play of chance, confounding, or a true effect of GTN, further randomized evidence on the use of vasodilators in ultra-acute intracerebral hemorrhage is needed. Clinical Trial Registration- URL: http://www.controlled-trials.com. Unique identifier: ISRCTN26986053.

Background and Purpose: Most randomized controlled trials of venous thromboembolism prophylaxis have focused on reduction of deep vein thrombosis, predominantly asymptomatic deep vein thrombosis, detected on imaging. We aimed to estimate the effects of graduated compression stockings on venous thromboembolism events, survival, and functional status at 6 months after stroke., Methods: The CLOTS Trials adopted an international multicentre, parallel group design, with central randomization and a 1:1 treatment allocation. In CLOTS Trial 1, 2518 immobile stroke patients were allocated thigh-length graduated compression stockings or not, and in CLOTS trial 2, 3014 to thigh-length or below-knee graduated compression stockings. We measured vital status, Oxford Handicap Scale, and quality of life (EQ5D-3 L) at 6 months., Results: We compared survival in patients enrolled in Trials 1 and 2 with a Cox proportional hazards model, including variables included in our minimization algorithm. In both trials, allocation to thigh-length graduated compression stockings was associated with a very slight, but nonsignificant, increased hazard of death in the first 6 months (Trial 1: hazard ratio, 1.087; 95% confidence interval, 0.913-1.295; and Trial 2: hazard ratio, 1.037; 95% confidence interval, 0.892-1.205). There were no statistically significant differences in venous thromboembolism events, Oxford Handicap Scale, or EQ5D-3 L between the treatment groups in CLOTS Trials 1 or 2., Conclusions: Although underpowered to detect clinically important effects on long-term outcomes, our results effectively exclude a >10% relative reduction in the hazard of death within 6 months associated with the use of thigh-length stockings. No other long-term benefits were apparent.

Background and Purpose: Carotid intervention by carotid endarterectomy (CEA) or endovascular treatment may cause hemodynamic change. The immediate and long-term effects on blood pressure after these procedures were assessed., Methods: Patients were randomized to CEA (n=49) or endovascular treatment (n=55) that comprised percutaneous transluminal angioplasty alone (n=31), balloon-expandable stent (n=13), or self-expandable stent (n=11). A baseline 24-hour ambulatory blood pressure recording was made before carotid intervention and repeated at 24 hours, 1 month, and 6 months after the procedure., Results: In the first 24 hours after the procedure, episodes of hypotension occurred in 75% of the CEA group and 76% of the endovascular group; hypertension occurred in 11% and 13%, respectively. There was a significant fall in blood pressure at 1 hour after the procedure in both groups (24 and 16 mm Hg fall in CEA and endovascular groups, respectively), but this was only sustained in the endovascular group. The pattern of blood pressure response in the first 24 hours was significantly different (P<0.0001, ANCOVA). Systolic blood pressure was significantly lower at 1 and 6 months only in the surgical group (6 and 5 mm Hg fall, respectively)., Conclusions: Both CEA and endovascular treatment have an effect on blood pressure stability, particularly within the first 24 hours after the procedure.

Background and Purpose: Percutaneous transluminal angioplasty combined with vascular stenting is currently being assessed in the treatment of patients with symptomatic, severe carotid stenosis. The immediate cerebral hemodynamic effects resulting from stenting are not fully understood. This article describes a novel finding: abnormal leptomeningeal enhancement after stenting shown by MRI., Methods: Fourteen patients with symptomatic severe carotid bifurcation stenosis underwent MRI within 4 hours before and within 3 hours after attempted carotid stenting. Twelve patients were successfully stented. Part of the MR investigation consisted of the acquisition of T1-weighted images before and after administration of the contrast agent Gd-DTPA, both before and after the procedure., Results: All 12 patients who underwent successful stenting did not have abnormal enhancement of the leptomeninges before stenting but developed unilateral enhancement following intervention but before the second injection of contrast agent. No contrast enhancement was detected in the 2 patients who had the angiographic procedure but were not stented., Conclusions: These findings suggest that abnormal changes to the leptomeningeal vasculature occur during carotid stenting which are not associated with sudden development of neurological symptoms. The anatomic distribution of the enhancement suggests that it is a consequence of the sudden change in brain hemodynamics secondary to the improvement in carotid flow after stenting.

Background and Purpose: The risk of major vascular events after an initial episode of cerebral ischemia in patients with nonrheumatic atrial fibrillation (NRAF) varies from 2% to 15% in the first year and is approximately 5% yearly thereafter. Few studies have reported on risk factors that can be used to identify high-risk subgroups within this patient population., Methods: We studied the predictive value of several easily obtainable clinical characteristics in a group of 375 placebo-treated patients with NRAF and a recent episode of transient or nondisabling cerebral ischemia who were entered in a multicenter clinical trial. The mean follow-up was 1.6 years., Results: By means of multivariate modeling, six independent variables were identified: history of previous thromboembolism, ischemic heart disease, enlarged cardiothoracic ratio on chest roentgenogram, systolic blood pressure greater than 160 mm Hg at study entry, NRAF for more than 1 year, and presence of an ischemic lesion on CT scan. These variables could also be used to stratify patients in low-, medium-, and high-risk subgroups for the other two arms of the trial, those treated with anticoagulation and aspirin. Patients older than 75 years with three or more risk factors seemingly benefited less from both aspirin and anticoagulant treatment., Conclusions: Easily obtainable patient characteristics are helpful in estimating the potential effect of adequate secondary prevention in patients with NRAF who recently suffered a transient ischemic attack or minor ischemic stroke.