DIRECT-MT
Trial question
Is endovascular thrombectomy alone noninferior to endovascular thrombectomy preceded by intravenous alteplase in patients with AIS?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
44.0% female
56.0% male
N = 656
656 patients (286 female, 370 male).
Inclusion criteria: patients with AIS 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-American Stroke Association 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).
Primary outcome
Modified Rankin Scale score at 90 days
3 points
3 points
3.0 points
2.3 points
1.5 points
0.8 points
0.0 points
Thrombectomy
alone
Combination
therapy
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in mRS score at 90 days (3 points vs. 3 points; 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).
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 ICH.
Conclusion
In patients with AIS 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.
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