6/28/23, 1:16 AM DIRECT-MT Pathway Feedback Search Clinical Topics Home Studies DIRECT MT DIRECT MT Disease Acute ischemic stroke Trial question Is endovascular thrombectomy alone noninferior to endovascular thrombectomy preceded by intravenous alteplase in patients with acute ischemic stroke? Study design Multi-center Open label RCT Population Characteristics of study participants 44.0% female N = 656 56.0% male 656 patients (286 female, 370 male) Inclusion criteria: patients with acute ischemic stroke from large-vessel occlusion in the anterior circulation Key exclusion criteria: disability before the stroke or any contraindication to intravenous alteplase according to the AHA (AHA)-American Stroke Association (ASA) guidelines Interventions N=327 thrombectomy-alone (endovascular thrombectomy) N=329 combination-therapy (endovascular thrombectomy preceded by intravenous alteplase at a dose of 0.9 mg/kg of body weight administered within 4.5 hours of symptom onset) https://web.pathway.md/studies/rec89GdFUyw6FMVa5 1/2 6/28/23, 1:16 AM DIRECT-MT Pathway Primary outcome Modified Rankin Scale score at 90 days 3.0 3 3 2.3 1.5 Difference not exceeding nonferiority margin 0.8 0.0 Thrombectomy-alone Combination-therapy Difference not exceeding nonferiority margin in mRS score at 90 days (3 vs. 3; aOR 1.07, 95% CI 0.81 to 1.4) Secondary outcomes No significant difference in death at 90 days (17.7% vs. 18.8%; RR 0.94, 95% CI 0.68 to 1.3) Borderline significant decrease in successful reperfusion before thrombectomy (2.4% vs. 7%; OR 0.33, 95% CI 0.14 to 0.74) No significant difference in overall successful reperfusion (79.4% vs. 84.5%; OR 0.7, 95% CI 0.47 to 1.06) Safety outcomes No significant differences in serious adverse events, procedural complications, asymptomatic and symptomatic intracranial hemorrhage. Conclusion In patients with acute ischemic stroke from large-vessel occlusion in the anterior circulation, thrombectomy-alone was noninferior to combination-therapy with respect to mRS score at 90 days. Reference Pengfei Yang, Yongwei Zhang, Lei Zhang et al. Endovascular Thrombectomy with or without Intravenous Alteplase in Acute Stroke. N Engl J Med. 2020 May 21;382(21):1981-1993. Open reference URL https://web.pathway.md/studies/rec89GdFUyw6FMVa5 2/2