For a study, researchers sought to determine if direct transport to a thrombectomy-capable facility was more useful in nonurban settings than transfer to the nearest local stroke center. Between March 2017 and June 2020, a multicenter, population-based, cluster-randomized trial involving 1,401 patients with suspected acute large-vessel occlusion stroke treated by emergency medical services in areas where the closest local stroke center was unable to perform thrombectomy. The last follow-up was scheduled for September 2020.
In the target cohort of patients with ischemic stroke, the primary outcome was impairment at 90 days based on the modified Rankin Scale (mRS; scores range from 0 [no symptoms] to 6 [death]). The incidence of intravenous tissue plasminogen activator administration and thrombectomy in the target group, as well as 90-day death in the safety population of all randomized patients, were among the 11 secondary outcomes.
After a second interim review, enrollment was terminated due to futility. The safety analysis included 1,401 enrolled patients, of which 1,369 (98%) consented to participate and were included in the as-randomized analysis (56% men; median age, 75 [IQR, 65-83] years; median National Institutes of Health Stroke Scale score, 17 [IQR, 11-21]); 949 (69%) comprised the target ischemic stroke population included in the primary analysis. The median mRS score was 3 (IQR, 2-5) in the target population versus 3 (IQR, 2-5). (adjusted common odds ratio [OR], 1.03; 95% CI, 0.82-1.29). About 8 of the 11 secondary outcomes reported indicated no meaningful difference. Patients directly transported to thrombectomy-capable centers had significantly lower odds of receiving intravenous tissue plasminogen activator (in the target population, 229/482 [47.5%] vs 282/467 [60.4%]; OR, 0.59; 95% CI, 0.45-0.76) and significantly higher odds of receiving thrombectomy (in the target population, 235/482 [48.8%] vs 184/467 [39.4%] At 90 days, there was no significant difference in mortality across groups (188/688 [27.3%] vs 194/713 [27.2%]; adjusted hazard ratio, 0.97; 95% CI, 0.79-1.18).
In patients with suspected large-vessel occlusion stroke in non-urban regions, there was no significant difference in 90-day neurological outcomes between transportation to a local stroke center versus a thrombectomy-capable referral facility. The findings must be confirmed in different scenarios.