Endovascular thrombectomy with or without intravenous thrombolysis in large-vessel ischemic stroke: A non-inferiority meta-analysis of 6 randomised controlled trials

• Published in: Vascular pharmacology Vol. 150; p. 107177
• Main Authors: Horvath, Lisa Christina, Bergmann, Felix, Hosmann, Arthur, Greisenegger, Stefan, Kammerer, Kerstin, Jilma, Bernd, Siller-Matula, Jolanta M., Zeitlinger, Markus, Gelbenegger, Georg, Jorda, Anselm
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.06.2023
• Subjects: Alteplase; Cardiovascular; Endovascular thrombectomy; Intravenous thrombolysis; Large vessel occlusion; Reperfusion; Stroke; Endovascular thrombectomy; Stroke; ASPECTS; RoB; mTICI/eTICI; ICA; MeSH; PRISMA; EQ-5D-5L; MCA; SITS-MOST; mRS; NINDS; ORs; RD; RRs; Reperfusion; Alteplase; MCID; GRADE; Intravenous thrombolysis; 95% CI; Large vessel occlusion; Alberta Stroke Program Early CT score; Preferred Reporting Items for Systematic Reviews and Meta-Analyses; risk difference; EuroQoL Group 5-Dimension 5-Level Self-Report questionnaire; risk ratios; internal carotid artery; Safe Implementation of Thrombolysis in Stroke-Monitoring Study; Medical Subject Headings; odds ratios; National Institute of Neurological Disorders and Stroke; Grading of Recommendations, Assessment, Development and Evaluations; Risk of Bias; middle cerebral artery; minimal clinically significant difference; modified Rankin scale; 95% confidence intervals; modified or expanded Thrombolysis in Cerebral Infarction
• ISSN: 1537-1891; 1879-3649; 1879-3649
• DOI: 10.1016/j.vph.2023.107177

It is unclear whether thrombectomy alone is non-inferior to thrombectomy with intravenous thrombolysis in patients with acute ischemic stroke due to large-vessel occlusion. To perform a comprehensive, trial-level data, non-inferiority meta-analysis of randomised controlled trials comparing endovascular thrombectomy with and without intravenous thrombolysis in patients with ischemic stroke due to large-vessel occlusion of anterior circulation. The prespecified primary efficacy outcome was functional independence, defined as a modified Rankin scale (mRS)score of 0 to 2 at 90 days. The two prespecified non-inferiority margins were risk differences of −10% and − 5%. The study was registered in PROSPERO (CRD42022361110) and conducted according to PRISMA guidelines. Six trials were included in this analysis (DIRECT-MT, DEVT, SKIP, MR CLEAN-NO IV, DIRECT-SAFE and SWIFT DIRECT) comprising a total of 2334 patients. Functional independence at 90 days was achieved by 570 (49·0%) of 1164 patients in the thrombectomy alone group and 595 (50·9%) of 1170 patients in the thrombectomy with thrombolysis group (pooled risk difference − 0·02, [95% CI -0·06–0·02]). Combined thrombectomy and thrombolysis were associated with significantly higher rates of successful reperfusion (pooled risk ratio 0·96 [95% CI, 0·93–0·99], p = 0·006) but at the expense of a significantly increased risk of overall - but not symptomatic - intracranial haemorrhage (pooled risk ratio 0·87 [95% CI, 0·77–0·98], p = 0·02). Compared with a combined treatment approach, thrombectomy alone was non-inferior at −10% non-inferiority margin, but not at a − 5% inferiority margin for functional independence. Current evidence cannot exclude clinically important differences between the two treatment approaches. [Display omitted]