The trial planned to recruit 1500 patients but was stopped after the enrolment of 628 patients due to a significantly higher symptomatic intracranial haemorrhage risk in participants receiving ...aspirin than in those not receiving aspirin (43 14% of 310 vs 23 7% of 318; adjusted odds ratio 1·95 95% CI 1·13–3·35), as well as in those receiving unfractionated heparin than in those not receiving unfractionated heparin (44 13% of 332 vs 22 7% of 296; 1·98 1·14–3·46). The primary outcome of the 90-day modified Rankin Scale score suggested worse outcomes in the treatment groups compared with those not receiving aspirin or unfractionated heparin, with a significant unfavourable shift in the modified Rankin Scale score in the moderate-dose heparin group. Current guidelines discourage heparin use in combination with intravenous thrombolytics and recommend postponing antiplatelets start after thrombolytic therapy.9 Considering the high risk of death in the moderate-dose heparin group of this trial (20 47% of 43 patients), and among those receiving intravenous thrombolysis plus aspirin and moderate-dose heparin (ten 63% of 16), it is prudent to avoid the administration of heparin in patients receiving thrombolysis irrespective of endovascular therapy.
BACKGROUND AND PURPOSE—We report on workflow and process-based performance measures and their effect on clinical outcome in Solitaire FR Thrombectomy for Acute Revascularization (STAR), a ...multicenter, prospective, single-arm study of Solitaire FR thrombectomy in large vessel anterior circulation stroke patients.
METHODS—Two hundred two patients were enrolled across 14 centers in Europe, Canada, and Australia. The following time intervals were measuredstroke onset to hospital arrival, hospital arrival to baseline imaging, baseline imaging to groin puncture, groin puncture to first stent deployment, and first stent deployment to reperfusion. Effects of time of day, general anesthesia use, and multimodal imaging on workflow were evaluated. Patient characteristics and workflow processes associated with prolonged interval times and good clinical outcome (90-day modified Rankin score, 0–2) were analyzed.
RESULTS—Median times were onset of stroke to hospital arrival, 123 minutes (interquartile range, 163 minutes); hospital arrival to thrombolysis in cerebral infarction (TICI) 2b/3 or final digital subtraction angiography, 133 minutes (interquartile range, 99 minutes); and baseline imaging to groin puncture, 86 minutes (interquartile range, 24 minutes). Time from baseline imaging to puncture was prolonged in patients receiving intravenous tissue-type plasminogen activator (32-minute mean delay) and when magnetic resonance–based imaging at baseline was used (18-minute mean delay). Extracranial carotid disease delayed puncture to first stent deployment time on average by 25 minutes. For each 1-hour increase in stroke onset to final digital subtraction angiography (or TICI 2b/3) time, odds of good clinical outcome decreased by 38%.
CONCLUSIONS—Interval times in the STAR study reflect current intra-arterial therapy for patients with acute ischemic stroke. Improving workflow metrics can further improve clinical outcome.
CLINICAL TRIAL REGISTRATION—URLhttp://www.clinicaltrials.gov. Unique identifierNCT01327989.
The advent of mechanical thrombectomy and increasing alteplase use have transformed the care of patients with acute ischemic stroke. Patients with major arterial occlusions with poor outcomes now ...have a chance of returning to independent living in more than half of the cases. However, many patients with these severe strokes suffer major disability despite these therapies. The search is ongoing for agents that can be combined with thrombectomy to achieve better recovery through halting infarct growth and mitigating injury after ischemic stroke. Several studies in animals and humans have demonstrated that therapeutic hypothermia (TH) offers potential to interrupt the ischemic cascade, reduce infarct volume, and improve functional independence. We performed a literature search to look up recent advances in the use of TH surrounding the science, efficacy, and feasibility of inducing TH in modern stroke treatments. While protocols remain controversial, there is a real opportunity to combine TH with the existing therapies to improve outcome in adults with acute ischemic stroke.
BACKGROUND AND PURPOSE:Available data on the clinical course of patients with acute ischemic stroke due to medium vessel occlusion (MeVO) are mostly limited to those with M2 segment occlusions. ...Outcomes are generally better compared with more proximal occlusions, but many patients will still suffer from severe morbidity. We aimed to determine the clinical course of acute ischemic stroke due to MeVO with and without intravenous alteplase treatment.
METHODS:Patients with MeVO (M2/M3/A2/A3/P2/P3 occlusion) from the INTERRSeCT (The Identifying New Approaches to Optimize Thrombus Characterization for Predicting Early Recanalization and Reperfusion With IV Alteplase and Other Treatments Using Serial CT Angiography) and PRoveIT (Precise and Rapid Assessment of Collaterals Using Multi-Phase CTA in the Triage of Patients With Acute Ischemic Stroke for IA Therapy) studies were included. Baseline characteristics and clinical outcomes were summarized using descriptive statistics. The primary outcome was a modified Rankin Scale score of 0 to 1 at 90 days, describing excellent functional outcome. Secondary outcomes were the common odds ratio for a 1-point shift across the modified Rankin Scale and functional independence, defined as modified Rankin Scale score of 0 to 2. We compared outcomes between patients with versus without intravenous alteplase treatment and between patients who did and did not show recanalization on follow-up computed tomography angiography. Logistic regression was used to provide adjusted effect-size estimates.
RESULTS:Among 258 patients with MeVO, the median baseline National Institutes of Health Stroke Scale score was 7 (interquartile range5–12). A total of 72.1% (186/258) patients were treated with intravenous alteplase and in 41.8% (84/201), recanalization of the occlusion (revised arterial occlusive lesion score 2b/3) was seen on follow-up computed tomography angiography. Excellent functional outcome was achieved by 50.0% (129/258), and 67.4% (174/258) patients gained functional independence, while 8.9% (23/258) patients died within 90 days. Recanalization was observed in 21.4% (9/42) patients who were not treated with alteplase and 47.2% (75/159) patients treated with alteplase (P=0.003). Early recanalization (adjusted odds ratio, 2.29 95% CI, 1.23–4.28) was significantly associated with excellent functional outcome, while intravenous alteplase was not (adjusted odds ratio, 1.70 95% CI, 0.88–3.25).
CONCLUSIONS:One of every 2 patients with MeVO did not achieve excellent clinical outcome at 90 days with best medical management. Early recanalization was strongly associated with excellent outcome but occurred in <50% of patients despite intravenous alteplase treatment.
Numerous studies have reported a decline in stroke-related mortality in developed countries.
To assess trends in one-year mortality following a stroke diagnosis in Saudi Arabia.
Retrospective ...longitudinal cohort study.
Single tertiary care center from 2010 through 2014.
All patients admitted with a primary admitting diagnosis of stroke.
Demographic data (age, gender, nationality), risk factor profile, stroke subtypes, in-hospital complications and mortality data as well as cause of death were collected for all patients. A multivariable logistic regression model was used to assess factors associated with one-year mortality following a stroke admission.
One-year mortality.
In 548 patients with a mean age of 62.9 years (SD 16.9), the most frequent vascular risk factors were hypertension (90.6%), diabetes (65.5%), and hyperlipidemia (27.2%). Hemorrhagic stroke was diagnosed in 9.9%. The overall mortality risk was 26.9%. Non-Saudis had a significantly higher one-year mortality risk compared with Saudis (25% vs. 16.8%, respectively; P=.025). The most frequently reported causes of mortality were neurological and related to the underlying stroke (32%), sepsis (30%), and cardiac or other organ dysfunction-related (each 9%) in addition to other etiologies (collectively 9.5%) such as pulmonary embolism or an underlying malignancy. Significant predictors in the multivariate model were age (P < .0001), non-Saudi nationality (OR 1.8, CI 95 1.1 to 2.9; P=.019), and hospital length of stay (OR 1.01, CI 95 1 to 1.004; P=.001).
We observed no decline in stroke mortality in our center over the 5-year span. The establishment of stroke systems of care, use of thrombolytic agents, and opening of a stroke unit should play an important role in a decline in stroke mortality.
Retrospective single center study. Mortality data were available only for patients who died in our hospital.
BACKGROUND—Meaningful delays occurred in the Interventional Management of Stroke (IMS) III trial. Analysis of the work flow will identify factors contributing to the in-hospital delays.
METHODS AND ...RESULTS—In the endovascular arm of the IMS III trial, the following time intervals were calculatedstroke onset to emergency department arrival; emergency department to computed tomography (CT); CT to intravenous tissue plasminogen activator start; intravenous tissue plasminogen activator start to randomization; randomization to groin puncture; groin puncture to thrombus identification; thrombus identification to start of endovascular therapy; and start of endovascular therapy to reperfusion. The effects of enrollment time, CT angiography use, interhospital transfers, and intubation on work flow were evaluated. Delays occurred notably in the time intervals from intravenous tissue plasminogen activator initiation to groin puncture (median 84 minutes) and start of endovascular therapy to reperfusion (median 85 minutes). The CT to groin puncture time was significantly shorter during working hours than after. Times from emergency department to reperfusion and groin puncture to reperfusion decreased over the trial period. Patients with CT angiography had shorter emergency department to reperfusion and onset to reperfusion times. Transfer of patients resulted in a longer onset to reperfusion time compared with those treated in the same center. Age, sex, National Institutes of Health Stroke Scale score, and intubation did not affect delays.
CONCLUSIONS—Important delays were identified before reperfusion in the IMS III trial. Delays decreased as the trial progressed. Use of CT angiography and endovascular treatment in the same center were associated with time savings. These data may help in optimizing work flow in current and future endovascular trials.
CLINICAL TRIAL REGISTRATION—URLhttp://www.clinicaltrials.gov. Unique identifierNCT00359424.
Trials of endovascular thrombectomy (EVT) for acute stroke have excluded patients with pre-morbid disability. Observational studies may help inform consideration of EVT in this population. We aimed ...to assess the effectiveness and safety of EVT in patients with pre-morbid disability.
According to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we searched MEDLINE and Embase for studies describing outcomes in patients with pre-morbid disability (modified Rankin Scale (mRS) 2-5), treated with EVT or medical management (MM). Random-effects meta-analysis was used to pool outcomes including 90-day return to baseline mRS, symptomatic intracerebral hemorrhage (sICH), and 90-day mortality.
We analyzed 14 studies of patients with pre-morbid disability (mRS 2-5, 1373 EVT and 253 MM). The rate of return to baseline mRS was 30.0% (95% CI 25.3% to 34.7%) in patients treated with EVT. Compared with medical therapy, EVT was associated with a higher likelihood of return to baseline mRS (OR 2.37, 95% CI 1.39 to 4.04) and a trend towards lower mortality (OR 0.68, 95% CI 0.46 to 1.02), with similar odds of sICH (OR 1.01, 95% CI 0.49 to 2.08). In studies comparing patients with versus without pre-morbid disability treated with EVT, similar results were found except that pre-morbid disability, when defined more strictly as mRS 3-5, was associated with mortality (OR 3.49, p<0.001).
In eligible patients with pre-morbid disability, observational studies suggest that EVT carries a higher chance of return to baseline mRS compared with patients treated with MM or without pre-morbid disability, although with higher mortality than patients without pre-morbid disability. These findings argue against the routine exclusion of such patients from EVT and merit validation with randomized trials.
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