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Review
. 2022 Mar;14(3):227-232.
doi: 10.1136/neurintsurg-2021-017667. Epub 2021 Jul 15.

Endovascular thrombectomy without versus with intravenous thrombolysis in acute ischemic stroke: a non-inferiority meta-analysis of randomized clinical trials

Chun-Hsien Lin  1 , Jeffrey L Saver  2 , Bruce Ovbiagele  3 , Wen-Yi Huang  4 , Meng Lee  5
Affiliations
Review

Endovascular thrombectomy without versus with intravenous thrombolysis in acute ischemic stroke: a non-inferiority meta-analysis of randomized clinical trials

Chun-Hsien Lin et al. J Neurointerv Surg. 2022 Mar.

Abstract

Objective: To conduct a meta-analysis of randomized trials to comprehensively compare the effect of endovascular thrombectomy (EVT) versus intravenous thrombolysis (IVT) plus EVT on functional independence (modified Rankin Scale (mRS) 0-2) after acute ischemic stroke due to large vessel occlusions (AIS-LVO).

Methods: We searched Pubmed, EMBASE, CENTRAL, and clinicaltrials.gov from January 2000 to February 2021 and abstracts presented at the International Stroke Conference in March 2021 to identify trials comparing EVT alone versus IVT plus EVT in AIS-LVO. Five non-inferiority margins established in the literature were assessed: -15%, -10%, -6.5%, -5%, and -1.3% for the risk difference for functional independence at 90 days.

Results: Four trials met the selection criteria, enrolling 1633 individuals, with 817 participants randomly assigned to EVT alone and 816 to IVT plus EVT. Crude cumulative rates of 90-day functional independence were 46.0% with EVT alone versus 45.5% with IVT plus EVT. Pooled results showed the risk difference of functional independence was 1% (95% CI -4% to 5%) between EVT alone versus IVT plus EVT. The lower 95% CI bound of -4% fell within the non-inferiority margins of -15%, -10%, -6.5%, and -5%, but not -1.3%. Pooled results also showed the risk difference between EVT alone versus IVT plus EVT was 1% (95% CI -3% to 5%) for mRS 0-1, and 1% (95% CI -1% to 3%) for symptomatic intracranial hemorrhage.

Conclusions: This meta-analysis suggests that EVT alone is non-inferior to IVT plus EVT for several, but not the most stringent, non-inferiority margins.

Keywords: stroke; thrombectomy; thrombolysis.

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Conflict of interest statement

Competing interests: Dr Saver reported being an employee of the University of California, which has patent rights in retrieval devices for stroke. The University of California received payments on the basis of clinical trial contracts for the number of participants enrolled in multicenter clinical trials sponsored by Medtronic, Stryker, Cerenovus, BrainsGate, NONO Inc., and Boehringer Ingelheim (prevention only). The University of California receives grant support from the National Institutes of Health (NIH) for Dr Saver’s service in leadership roles in the National Institute of Neurological Disorders and Stroke StrokeNet national clinical trial network and from Diffusion Pharma for Dr Saver’s leadership role in the PHAST-TSC multicenter trial. Dr Saver reported serving as an unpaid consultant to Genentech advising on the design and conduct of the PRISMS trial; neither the University of California nor Dr Saver received any payments for this voluntary service. Dr Saver paid for his own travel. Dr Saver reported receiving contracted hourly payments and travel reimbursement for services as a scientific consultant advising on rigorous trial design and conduct to Medtronic, Stryker, Cerenovus, BrainsGate, Boehringer Ingelheim (prevention only), NONO Inc., BrainQ, and Abbott; contracted stock options for services as a scientific consultant advising on rigorous trial design and conduct to Rapid Medical; and personal fees from Johnson & Johnson and Novo Nordisk.

Figures

Figure 1
Figure 1
Flow of study selection. ISC, International Stroke Conference.
Figure 2
Figure 2
Functional independence. Forest plot comparing EVT alone versus IVT before EVT for functional independence (modified Rankin Scale 0–2). The lower 95% CI bound of −4% fell within the non-inferiority margins of −15%, −10%, –6.5%, and −5%, but crossed the most stringent non-inferiority margin of −1.3%. CI, confidence interval; EVT, endovascular thrombectomy; IVT, intravenous thrombolysis.
Figure 3
Figure 3
Freedom of disability. Forest plot comparing EVT alone versus IVT before EVT for freedom of disability (modified Rankin Scale 0–1). The lower 95% CI bound of −3% fell within the non-inferiority margins of −15%, −10%, –6.5%, and −5%, but crossed the most stringent non-inferiority margin of −1.3%. CI, confidence interval; EVT, endovascular thrombectomy; IVT, intravenous thrombolysis.
Figure 4
Figure 4
Intracranial hemorrhage. Forest plot comparing EVT alone versus IVT before EVT for (A) any intracranial hemorrhage and (B) symptomatic intracranial hemorrhage. CI, confidence interval; EVT, endovascular thrombectomy; IVT, intravenous thrombolysis.
See this image and copyright information in PMC

References

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