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Effect of Mechanical Thrombectomy Without vs With Intravenous Thrombolysis on Functional Outcome Among Patients With Acute Ischemic Stroke

By Currents Editor posted 02-25-2021 13:11


Journal of the American Medical Association (01/19/21) 325(3): 244  DOI: 10.1001/jama.2020.23522
Suzuki, Kentaro; Matsumaru, Yuji; Takeuchi, Masataka; et al.

For patients with acute large vessel occlusion stroke, new research shows that mechanical thrombectomy alone did not demonstrate noninferiority regarding favorable functional outcome, compared with the combination of I.V. thrombolysis and mechanical thrombectomy. The randomized, open-label clinical trial involved 204 patients with acute ischemic stroke due to large vessel occlusion at 23 hospital networks in Japan. A total of 101 patients were randomized to mechanical thrombectomy alone, while 103 received combined I.V. thrombolysis (alteplase at a 0.6-mg/kg dose) plus mechanical thrombectomy. A favorable functional outcome—defined as a modified Rankin Scale score of 0-2 at 90 days—occurred in 59.4% (60 patients) of those randomized to mechanical thrombectomy alone and 57.3% (59) of those in the combined treatment group, with no significant between-group difference. Among seven secondary efficacy endpoints, including mortality at day 90, and four safety endpoints, 10 were not significantly different. Any intracerebral hemorrhage at 36 hours from onset was lower in the mechanical thrombectomy group compared with the combined treatment group, but the rate of symptomatic intracerebral hemorrhage was not significantly different between the groups. Mechanical thrombectomy alone failed to demonstrate noninferiority in terms of favorable functional outcome when compared with combined I.V. thrombolysis plus mechanical thrombectomy in this patient population; however, the findings also did not allow for a conclusion of inferiority, given the wide confidence intervals around the effect estimate.


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