Background: Clinical trials addressing large core acute ischemic stroke (AIS) are ongoing across 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 studies. This common data element study aims to provide an overview of 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 trials.
Results: The most reported data element was ASPECTS score but with varied definitions of what constitutes 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 reported the frequency of serious adverse events, including mortality, at the 1-week and 12-month mark.
Discussion: Overall, in large core trials there is a large degree of heterogeneity in the collected data elements. Differences in definition and timepoints render reaching a unified standard difficult, which hinders high quality meta-analyses and cohesive evidence-driven synthesis.
Mohamed Sobhi Jabal, Mohamed K. Ibrahim, Jade Thurnham, Kevin M. Kallmes, Hassan Kobeissi, Sherief Ghozy, Nicole Hardy, Ranita Tarchand, Cem Bilgin, Jeremy J. Heit, Waleed Brinjikji, David F. Kallmes
- Systematic review of outcomes measured in trials
- Systematic review
A literature search was performed using Nested Knowledge (NK) (St. Paul, MN, USA) AutoLit platform. Screening of Medline and Embase databases as well as clinicaltrials.gov was done for relevant studies pertaining to active EVT trials for patients with
large core infarct. The following key terms were used: “large core”, “acute ischemic”, “stroke”, “thrombectomy”, and “low ASPECTS” on 27 April 2022.