Ibrahim, Mohamed Nabil

Background The modified Rankin Scale (mRS) score of ≤2 (functional independence) has been the most common primary endpoint of modern mechanical thrombectomy (MT) trials. However, unlike mRS 0-1, mRS score of 2 indicates disability. An important proportion of the mRS 2 patients are home dependent and report a significant decrease in their quality of life. Purpose To investigate excellent outcome (mRS 0-1) rates after MT. Methods We systematically searched Ovid MEDLINE, Ovid EMBASE, Cochrane Central Register of Controlled Trials, Scopus, and Web of Science databases. Randomized controlled trials (RCTs) investigating the role of modern MT in acute ischemic stroke were screened. Posterior circulation and large-core infarct trials were excluded from the study. The data regarding excellent outcomes (mRS: 0-1), functional independence (mRS: 0-2), and reperfusion were collected. Results Twenty-two RCTs comprising 5692 patients were included in the meta-analysis. The overall mRS 0-1 rate was 31.24% (95% CI = 26.95–36.2). The rate of successful reperfusion was 81.8% (95% CI = 77.93–85.86). MT achieved significantly higher rates of mRS 0-1 compared to standard care alone (OR = 2.04; 95% CI = 1.64–2.55; P-value < 0.001), with no heterogeneity detected among studies (I 2 = 0%; P-value = 0.52). The direct MT and MT plus intravenous thrombolytic treatment groups’ excellent outcome rates were comparable (OR = 0.98; 95% CI = 0.82–1.18; P-value = 0.863). Also, aspiration and stent retriever thrombectomy techniques provided similar excellent outcome rates (OR = 0.76; 95% CI = 0.55–1.05; P-value = 0.141). Conclusions Our results prove the additional benefit of MT over standard care, using a stricter definition for favorable functional outcome. Nearly one-third of patients presenting with large artery occlusion and treated with MT had no disability at 90 days. While this is remarkable, our results also indicate that reperfusion alone is often not enough to prevent disability and underline the need for better neuroprotection strategies.

Introduction Various clinical trials addressing large core acute ischemic stroke (AIS) are ongoing from multiple international groups. Future development of clinical guidelines depends on meta‐analyses of these trials calling for a degree of homogeneity of elements across the different studies. The aim of this common data element study was to provide an overview of the key features of pertinent large core infarct trials. Methods PubMed and ClinicalTrials.gov databases were screened for published and ongoing clinical trials assessing mechanical thrombectomy in patients with AIS with large core infarct. Nested Knowledge AutoLit living review platform was utilized to categorize primary and secondary outcomes as well as inclusion and exclusion criteria for patient selection in the clinical trials. Results The most reported data element was ASPECTS score, but with varied definitions of what compromises large core. Non‐utility‐weighted modified Rankin Score (mRS) was reported in 6/7 studies as the primary outcome, while the utility‐weighted mRS was the outcome of interest in the TESLA trial, all of them at the 3‐months mark, with only LASTE looking for mRS shift at the 6‐months mark. Secondary outcomes had more variations. Mortality is reported separately only in 4/7 trials, all at the 3‐month mark. Additionally, the TENSION trial reports the frequency of serious adverse events, including mortality, at the 1‐week and 12‐month mark. Conclusions In the published and the ongoing large core trials, there is a large degree of variability in the collected data elements. Differences in definition and timepoints renders reaching a unified standard difficult, which hinders high quality meta‐analyses and cohesive evidence‐driven synthesis.