Trials examining the benefit of thrombectomy in anterior circulation proximal large vessel occlusion stroke have enrolled patients considered to have salvageable brain tissue, who were randomly ...assigned beyond 6 h and (depending on study protocol) up to 24 h from time last seen well. We aimed to estimate the benefit of thrombectomy overall and in prespecified subgroups through individual patient data meta-analysis.
We did a systematic review and individual patient data meta-analysis between Jan 1, 2010, and March 1, 2021, of randomised controlled trials of endovascular stroke therapy. In the Analysis Of Pooled Data From Randomized Studies Of Thrombectomy More Than 6 Hours After Last Known Well (AURORA) collaboration, the primary outcome was disability on the modified Rankin Scale (mRS) at 90 days, analysed by ordinal logistic regression. Key safety outcomes were symptomatic intracerebral haemorrhage and mortality within 90 days.
Patient level data from 505 individuals (n=266 intervention, n=239 control; mean age 68·6 years SD 13·7, 259 51·3% women) were included from six trials that met inclusion criteria of 17 screened published randomised trials. Primary outcome analysis showed a benefit of thrombectomy with an unadjusted common odds ratio (OR) of 2·42 (95% CI 1·76–3·33; p<0·0001) and an adjusted common OR (for age, gender, baseline stroke severity, extent of infarction on baseline head CT, and time from onset to random assignment) of 2·54 (1·83–3·54; p<0·0001). Thrombectomy was associated with higher rates of independence in activities of daily living (mRS 0–2) than best medical therapy alone (122 45·9% of 266 vs 46 19·3% of 238; p<0·0001). No significant difference between intervention and control groups was found when analysing either 90-day mortality (44 16·5% of 266 vs 46 19·3% of 238) or symptomatic intracerebral haemorrhage (14 5·3% of 266 vs eight 3·3% of 239). No heterogeneity of treatment effect was noted across subgroups defined by age, gender, baseline stroke severity, vessel occlusion site, baseline Alberta Stroke Program Early CT Score, and mode of presentation; treatment effect was stronger in patients randomly assigned within 12–24 h (common OR 5·86 95% CI 3·14–10·94) than those randomly assigned within 6–12 h (1·76 1·18–2·62; pinteraction=0·0087).
These findings strengthen the evidence for benefit of endovascular thrombectomy in patients with evidence of reversible cerebral ischaemia across the 6–24 h time window and are relevant to clinical practice. Our findings suggest that in these patients, thrombectomy should not be withheld on the basis of mode of presentation or of the point in time of presentation within the 6–24 h time window.
Stryker Neurovascular.
Hospital readmissions following stroke are costly and lead to worsened patient outcomes. We examined readmissions rates, diagnoses at readmission, and risk factors associated with readmission ...following acute ischemic stroke (AIS) in a large United States (US) administrative database. Using the 2019 Nationwide Readmissions Database, we identified adults discharged with AIS (ICD-10-CM I63*) as the principal diagnosis. Survival analysis with Weibull accelerated failure time regression was used to examine variables associated with hospital readmission. In 2019, 273,811 of 285,451 AIS patients survived their initial hospitalization. Of these, 60,831 (22.2%) were readmitted within 2019. Based on Kaplan Meyer analysis, readmission rates were 9.7% within 30 days and 30.5% at 1 year following initial discharge. The most common causes of readmissions were stroke and post stroke sequalae (25.4% of 30-day readmissions, 15.0% of readmissions between 30-364 days), followed by sepsis (10.3% of 30-day readmissions, 9.4% of readmissions between 30-364 days), and acute renal failure (3.2% of 30-day readmissions, 3.0% of readmissions between 30-364 days). After adjusting for multiple patient and hospital-level characteristics, patients at increased risk of readmission were older (71.6 vs. 69.8 years, p<0.001) and had longer initial lengths of stay (7.6 vs. 6.2 day, p<0.001). They more often had modifiable comorbidities, including vascular risk factors (hypertension, diabetes, atrial fibrillation), depression, epilepsy, and drug abuse. Social determinants associated with increased readmission included living in an urban (vs. rural) setting, living in zip-codes with the lowest median income, and having Medicare insurance. All factors were significant at p<0.001. Unplanned hospital readmissions following AIS were high, with the most common reasons for readmission being recurrent stroke and post stroke sequalae, followed by sepsis and acute renal failure. These findings suggest that efforts to reduce readmissions should focus on optimizing secondary stroke and infection prevention, particularly among older socially disadvantaged patients.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
In this trial in patients with stroke who had a mismatch between sizes of early infarction and a hypoperfused brain region, endovascular thrombectomy at 6 to 16 hours after stroke onset was ...associated with a favorable shift in the distribution of disability scores at 90 days.
BACKGROUND AND PURPOSE—We evaluate associations between the severity of magnetic resonance perfusion-weighted imaging abnormalities, as assessed by the hypoperfusion intensity ratio (HIR), on infarct ...progression and functional outcome in the Diffusion and Perfusion Imaging Evaluation for Understanding Stroke Evolution Study 2 (DEFUSE 2).
METHODS—Diffusion-weighted magnetic resonance imaging and perfusion-weighted imaging lesion volumes were determined with the RAPID software program. HIR was defined as the proportion of TMax >6 s lesion volume with a Tmax >10 s delay and was dichotomized based on its median value (0.4) into low versus high subgroups as well as quartiles. Final infarct volumes were assessed at day 5. Initial infarct growth velocity was calculated as the baseline diffusion-weighted imaging (DWI) lesion volume divided by the delay from symptom onset to baseline magnetic resonance imaging. Total Infarct growth was determined by the difference between final infarct and baseline DWI volumes. Collateral flow was assessed on conventional angiography and dichotomized into good and poor flow. Good functional outcome was defined as modified Rankin Scale ≤2 at 90 days.
RESULTS—Ninety-nine patients were included; baseline DWI, perfusion-weighted imaging, and final infarct volumes increased with HIR quartiles (P<0.01). A high HIR predicted poor collaterals with an area under the curve of 0.73. Initial infarct growth velocity and total infarct growth were greater among patients with a high HIR (P<0.001). After adjustment for age, DWI volume, and reperfusion, a low HIR was associated with good functional outcomeodds ratio=4.4 (95% CI, 1.3–14.3); P=0.014.
CONCLUSIONS—HIR can be easily assessed on automatically processed perfusion maps and predicts the rate of collateral flow, infarct growth, and clinical outcome.
We hypothesized that automated assessment of collaterals on computed tomography perfusion can predict the rate of infarct growth during transfer from a primary to a comprehensive stroke center for ...endovascular stroke treatment. We identified consecutive patients (N = 28) and assessed their collaterals based on the hypoperfusion intensity ratio (HIR) prior to transfer. Infarct growth rate was strongly correlated with HIR (r = 0.78, p < 0.001). Receiver operating characteristic analysis identified HIR ≥ 0.5 as optimal for predicting infarct growth. Patients with HIR ≥ 0.5 had a median infarct growth rate of 10.1ml/h (interquartile range IQR = 6.4–18.4) compared with 0.9ml/h (IQR = 0–2.8; p < 0.001) in patients with HIR < 0.5. Patients with HIR ≥ 0.5 had an 83% probability of significant core growth, whereas patients with HIR < 0.5 had an 88% probability of core stability. These preliminary data have the potential to guide decision making regarding whether repeat brain imaging should be performed after transfer to a comprehensive stroke center. Ann Neurol 2018;84:616–620
Rationale
Early reperfusion in patients experiencing acute ischemic stroke is effective in patients with large vessel occlusion. No randomized data are available regarding the safety and efficacy of ...endovascular therapy beyond 6 h from symptom onset.
Aim
The aim of the study is to demonstrate that, among patients with large vessel anterior circulation occlusion who have a favorable imaging profile on computed tomography perfusion or magnetic resonance imaging, endovascular therapy with a Food and Drug Administration 510 K-cleared mechanical thrombectomy device reduces the degree of disability three months post stroke.
Design
The study is a prospective, randomized, multicenter, phase III, adaptive, blinded endpoint, controlled trial. A maximum of 476 patients will be randomized and treated between 6 and 16 h of symptom onset.
Procedures
Patients undergo imaging with computed tomography perfusion or magnetic resonance diffusion/perfusion, and automated software (RAPID) determines if the Target Mismatch Profile is present. Patients who meet both clinical and imaging selection criteria are randomized 1:1 to endovascular therapy plus medical management or medical management alone. The individual endovascular therapist chooses the specific device (or devices) employed.
Study outcomes
The primary endpoint is the distribution of scores on the modified Rankin Scale at day 90. The secondary endpoint is the proportion of patients with modified Rankin Scale 0–2 at day 90 (indicating functional independence).
Analysis
Statistical analysis for the primary endpoint will be conducted using a normal approximation of the Wilcoxon–Mann–Whitney test (the generalized likelihood ratio test).
Summary Background In animal models of acute ischaemic stroke, blocking of the leukocyte-endothelium adhesion by antagonism of α4 integrin reduces infarct volumes and improves outcomes. We assessed ...the effect of one dose of natalizumab, an antibody against the leukocyte adhesion molecule α4 integrin, in patients with acute ischaemic stroke. Methods In this double-blind, phase 2 study, patients with acute ischaemic stroke (aged 18–85 years) from 30 US and European clinical sites were randomly assigned (1:1) to 300 mg intravenous natalizumab or placebo with stratification by treatment window and baseline infarct size. Patients, investigators, and study staff were masked to treatment assignments. The primary endpoint was the change in infarct volume from baseline to day 5 and was assessed in the modified intention-to-treat population. Secondary endpoints were the change in infarct volume from baseline to day 30, and from 24 h to days 5 and 30; the National Institute of Health Stroke Scale (NIHSS) at baseline, 24 h, and at days 5 (or discharge), 30, and 90; and modified Rankin Scale (mRS) and Barthel Index (BI) at days 5 (or discharge), 30, and 90. This trial is registered with ClinicalTrials.gov , number NCT01955707. Findings Between Dec 16, 2013, and April 9, 2015, 161 patients were randomly assigned to natalizumab (n=79) or placebo (n=82). Natalizumab did not reduce infarct volume growth from baseline to day 5 compared with placebo (median absolute growth 28 mL range −8 to 303 vs 22 mL −11 to 328; relative growth ratio 1·09 90% CI 0·91–1·30, p=0·78) or to day 30 (4 mL −43 to 121 vs 4 mL −28 to 180; 1·05 0·88–1·27, p=0·68), from 24 h to day 5 (8 mL −30 to 177 vs 7 mL −13 to 204; 1·00 0·89–1·12, p=0·49), and from 24 h to day 30 (−5 mL −93 to 81 vs −5 mL −48 to 48; 0·98 0·87–1·11, p=0·40). No difference was noted between the natalizumab and placebo groups in the NIHSS (score ≤1 or ≥8 point improvement) from baseline at 24 h, day 5 (or discharge), day 30 (27 35% vs 36 44%; odds ratio 0·69 90% CI 0·39–1·21, p=0·86), and day 90 (36 47% vs 37 46%; 1·10 0·63–1·93, p=0·39). More patients in the natalizumab group than in the placebo group had mRS scores of 0 or 1 at day 30 (13 18% vs seven 9%; odds ratio 2·88 90% CI 1·20–6·93, p=0·024) and day 90 (18 25% vs 16 21%; 1·48 0·74–2·98, p=0·18); and BI (score ≥95) at day 90 (34 44% vs 26 33%; 1·91 1·07–3·41, p=0·033) but not significantly at day 5 or day 30 (26 34% vs 26 32%; 1·13 0·63–2·00, p=0·37). Natalizumab and placebo groups had similar incidences of adverse events (77 99% of 78 patients vs 81 99% of 82 patients), serious adverse events (36 46% vs 38 46%), and deaths (14 18% vs 13 16%). Two patients in the natalizumab group died because of adverse events assessed as related to treatment by the investigator (pneumonia, and septic shock and multiorgan failure). Interpretation Natalizumab administered up to 9 h after stroke onset did not reduce infarct growth. Treatment-associated benefits on functional outcomes might warrant further investigation. Funding Biogen.
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