on behalf of the Improving Reperfusion strategies in Ischemic Stroke (IRIS) working group investigators (DIRECT MT; MR CLEAN noIV; DEVT; SKIP; SAFE DIRECT; SWIFT DIRECT)
Whether direct mechanical thrombectomy (MT) in acute ischaemic stroke patients with large vessel occlusion (LVO) is equally effective as intravenous thrombolysis (IVT) with alteplase followed by MT remains a matter of debate. Primary aim of this study was to test non-inferiority of direct mechanical thrombectomy using summary estimates of study-level aggregate data of all randomized controlled trials evaluating direct MT vs IVT followed by MT. Secondary aims included superiority testing of IVT followed by MT versus direct MT and presentation of relevant secondary outcomes.
We performed a PROSPERO registered, prespecified, systematic review of electronic databases (Web of Science, PubMed, Embase) and meta-analysis with data presentation adherent to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Random effects models were used to pool the study-level data. The primary outcome used for non-inferiority and superiority testing was good functional outcome at 90 days (mRS≤2). The non-inferiority margin was prespecified. Secondary outcomes included excellent functional outcome (mRS≤1), mortality, symptomatic intracranial haemorrhage (sICH), successful reperfusion (TICI≥2b) and procedure-related complications. Five RCTs comprising 2043 patients (xy dMT, yx bridging therapy) were included.
To be determined
To be determined
SWIFT DIRECT NCT03192332
MR CLEAN-NO IV ISRCTN80619088
SKIP UMIN000021488
DIRECT-MT NCT03469206
DEVT ChiCTR-IOR-17013568