Randomized assessment of rapid endovascular treatment of ischemic stroke.
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Goyal Mayank, Demchuk Andrew M, Menon Bijoy K, Eesa Muneer, Rempel Jeremy L, Thornton John, Roy Daniel, Jovin Tudor G, Willinsky Robert A, Sapkota Biggya L, Dowlatshahi Dar, Frei Donald F, Kamal Noreen R, Montanera Walter J, Poppe Alexandre Y, Ryckborst Karla J, Silver Frank L, Shuaib Ashfaq, Tampieri Donatella, Williams David, Bang Oh Young, Baxter Blaise W, Burns Paul A, Choe Hana, Heo Ji-Hoe, Holmstedt Christine A, Jankowitz Brian, Kelly Michael, Linares Guillermo, Mandzia Jennifer L, Shankar Jai, Sohn Sung-Il, Swartz Richard H, Barber Philip A, Coutts Shelagh B, Smith Eric E, Morrish William F, Weill Alain, Subramaniam Suresh, Mitha Alim P, Wong John H, Lowerison Mark W, Sajobi Tolulope T, Hill Michael D, ESCAPE Trial Investigators
Аннотация
METHODS: We randomly assigned participants to receive standard care (control group) or standard care plus endovascular treatment with the use of available thrombectomy devices (intervention group). Patients with a proximal intracranial occlusion in the anterior circulation were included up to 12 hours after symptom onset. Patients with a large infarct core or poor collateral circulation on computed tomography (CT) and CT angiography were excluded. Workflow times were measured against predetermined targets. The primary outcome was the score on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) at 90 days. A proportional odds model was used to calculate the common odds ratio as a measure of the likelihood that the intervention would lead to lower scores on the modified Rankin scale than would control care (shift analysis).
RESULTS: The trial was stopped early because of efficacy. At 22 centers worldwide, 316 participants were enrolled, of whom 238 received intravenous alteplase (120 in the intervention group and 118 in the control group). In the intervention group, the median time from study CT of the head to first reperfusion was 84 minutes. The rate of functional independence (90-day modified Rankin score of 0 to 2) was increased with the intervention (53.0%, vs. 29.3% in the control group; P<0.001). The primary outcome favored the intervention (common odds ratio, 2.6; 95% confidence interval, 1.7 to 3.8; P<0.001), and the intervention was associated with reduced mortality (10.4%, vs. 19.0% in the control group; P=0.04). Symptomatic intracerebral hemorrhage occurred in 3.6% of participants in intervention group and 2.7% of participants in control group (P=0.75).
CONCLUSIONS: Among patients with acute ischemic stroke with a proximal vessel occlusion, a small infarct core, and moderate-to-good collateral circulation, rapid endovascular treatment improved functional outcomes and reduced mortality. (Funded by Covidien and others; ESCAPE ClinicalTrials.gov number, NCT01778335.).