Background Direct mechanical thrombectomy (dMT) may result in similar outcomes compared to a bridging approach with intravenous thrombolysis (IVT+MT) in acute ischaemic stroke. Recent randomised controlled trials (RCTs) have varied in their design and non-inferiority margins (NIM). Aim We sought to meta-analyse accumulated trial data to assess the difference and non-inferiority in clinical and procedural outcomes between dMT and bridging therapy. Summary of review We conducted a systematic review of electronic databases following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Random effects meta-analyses were conducted for the pooled data. The primary outcome was good functional outcome at 90 days (modified Rankin Scale (mRS)â¤2). Secondary outcomes included excellent functional outcome (mRSâ¤1), mortality, any intracranial haemorrhage (ICH), symptomatic ICH, successful reperfusion (TICIï³2b) and procedure-related complications. Four RCTs comprising 1633 patients (817 dMT, 816 bridging therapy) were included. There were no statistical differences for the 90-day good functional outcome (OR=1.02, 95%CI 0.84-1.25, p=0.54, I2=0%), and the absolute risk difference was 1% (95% CI â4% to 5%). The lower 95% CI falls within the strictest NIM of -10% among included RCTs. dMT reduced the odds of successful reperfusion (OR=0.76, 95%CI 0.60-0.97, p=0.03, I2=0%) and any ICH (OR=0.65, 95%CI 0.49-0.86, p=0.003, I2=38%). There was no difference in the remaining secondary outcomes. The risk of bias for all studies was low. Conclusion The combined trial data assessing dMT versus bridging therapy showed no difference in improving good functional outcome. The wide non-inferiority thresholds set by individual trials are in contrast with the clinical consensus on minimally important differences. However, our pooled analysis indicates non-inferiority of dMT with a 4% margin of confidence. The application of these findings is limited to patients presenting directly to MT-capable centres and real-world workflow times may differ against those achieved in a trial setting.
Background: The impact on clinical outcomes of patient selection using perfusion imaging for endovascular thrombectomy (EVT) in patients with acute ischemic stroke presenting beyond 6 hours from onset remains undetermined in routine clinical practice. Methods: Patients from a national stroke registry that underwent EVT selected with or without perfusion imaging (noncontrast computed tomography/computed tomography angiography) in the early (<6 hours) and late (6–24 hours) time windows, between October 2015 and March 2020, were compared. The primary outcome was the ordinal shift in the modified Rankin Scale score at hospital discharge. Other outcomes included functional independence (modified Rankin Scale score ≤2) and in-hospital mortality, symptomatic intracerebral hemorrhage, successful reperfusion (Thrombolysis in Cerebral Infarction score 2b–3), early neurological deterioration, futile recanalization (modified Rankin Scale score 4–6 despite successful reperfusion) and procedural time metrics. Multivariable analyses were performed, adjusted for age, sex, baseline stroke severity, prestroke disability, intravenous thrombolysis, mode of anesthesia (Model 1) and including EVT technique, balloon guide catheter, and center (Model 2). Results: We included 4249 patients, 3203 in the early window (593 with perfusion versus 2610 without perfusion) and 1046 in the late window (378 with perfusion versus 668 without perfusion). Within the late window, patients with perfusion imaging had a shift towards better functional outcome at discharge compared with those without perfusion imaging (adjusted common odds ratio [OR], 1.45 [95% CI, 1.16–1.83]; P =0.001). There was no significant difference in functional independence (29.3% with perfusion versus 24.8% without; P =0.210) or in the safety outcome measures of symptomatic intracerebral hemorrhage ( P =0.53) and in-hospital mortality (10.6% with perfusion versus 14.3% without; P =0.053). In the early time window, patients with perfusion imaging had significantly improved odds of functional outcome (adjusted common OR, 1.51 [95% CI, 1.28–1.78]; P =0.0001) and functional independence (41.6% versus 33.6%, adjusted OR, 1.31 [95% CI, 1.08–1.59]; P =0.006). Perfusion imaging was associated with lower odds of futile recanalization in both time windows (late: adjusted OR, 0.70 [95% CI, 0.50–0.97]; P =0.034; early: adjusted OR, 0.80 [95% CI, 0.65–0.99]; P =0.047). Conclusions: In this real-world study, acquisition of perfusion imaging for EVT was associated with improvement in functional disability in the early and late time windows compared with nonperfusion neuroimaging. These indirect comparisons should be interpreted with caution while awaiting confirmatory data from prospective randomized trials.
BackgroundThe optimal anesthetic modality for endovascular treatment (EVT) in acute ischemic stroke (AIS) is undetermined. Comparisons of general anesthesia (GA) with composite non-GA cohorts of conscious sedation (CS) and local anesthesia (LA) without sedation have provided conflicting results. There has been emerging interest in assessing whether LA alone may be associated with improved outcomes. We conducted a systematic review and meta-analysis to evaluate clinical and procedural outcomes comparing LA with CS and GA.MethodsWe reviewed the literature for studies reporting outcome variables in LA versus CS and LA versus GA comparisons. The primary outcome was 90 day good functional outcome (modified Rankin Scale (mRS) score of ≤2). Secondary outcomes included mortality, symptomatic intracerebral hemorrhage, excellent functional outcome (mRS score ≤1), successful reperfusion (Thrombolysis in Cerebral Infarction (TICI) >2b), procedural time metrics, and procedural complications. Random effects meta-analysis was performed on unadjusted and adjusted data.ResultsEight non-randomized studies of 7797 patients (2797 LA, 2218 CS, and 2782 GA) were identified. In the LA versus GA comparison, no statistically significant differences were found in unadjusted analyses for 90 day good functional outcome or mortality (OR=1.22, 95% CI 0.84 to 1.76, p=0.3 and OR=0.83, 95% CI 0.64 to 1.07, p=0.15, respectively) or in the LA versus CS comparison (OR=1.14, 95% CI 0.76 to 1.71, p=0.53 and OR=0.88, 95% CI 0.62 to 1.24, p=0.47, respectively). There was a tendency towards achieving excellent functional outcome (mRS ≤1) in the LA group versus the GA group (OR=1.44, 95% CI 1.00 to 2.08, p=0.05, I2=70%). Analysis of adjusted data demonstrated a tendency towards higher odds of death at 90 days in the GA versus the LA group (OR=1.24, 95% CI 1.00 to 1.54, p=0.05, I2=0%).ConclusionLA without sedation was not significantly superior to CS or GA in improving outcomes when performing EVT for AIS. However, the quality of the included studies impaired interpretation, and inclusion of an LA arm in future well designed multicenter, randomized controlled trials is warranted.
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