DAWN
Trial question
What is the role of thrombectomy among patients with acute stroke who had last been known to be well 6 to 24 hours earlier and who had a mismatch between clinical deficit and infarct?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
55.0% female
45.0% male
N = 206
206 patients (113 female, 93 male).
Inclusion criteria: patients with occlusion of the intracranial internal carotid artery or proximal middle cerebral artery who had last been known to be well 6 to 24 hours earlier and who had a mismatch between the severity of the clinical deficit and the infarct volume.
Key exclusion criteria: history of severe head injury within past 90 days with residual neurological deficit, pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, known hemorrhagic diathesis, coagulation factor deficiency, severe sustained hypertension.
Interventions
N=107 thrombectomy (thrombectomy with the use of the Trevo device plus standard medical care).
N=99 control (standard medical care alone).
Primary outcome
Score on utility-weighted modified Rankin scale at 90 days
5.5 points
3.4 points
5.5 points
4.1 points
2.8 points
1.4 points
0.0 points
Thrombectomy
Control
Significant
increase ▲
Significant increase in score on utility-weighted mRS at 90 days (5.5 points vs. 3.4 points; AD 2 points, 95% CI 1.1 to 3).
Secondary outcomes
Significant increase in functional independence at 90 days (49% vs. 13%; AD 33%, 95% CI 21 to 44).
Significant increase in early response (48% vs. 19%; RR 3, 95% CI 2 to 4).
Significant increase in recanalization at 24 hours (77% vs. 39%; RR 2, 95% CI 2 to 4).
Safety outcomes
No significant differences in symptomatic ICH, death from any cause or stroke-related death at 90 days.
Significant difference in neurological deterioration (14% vs. 26%).
Conclusion
In patients with occlusion of the intracranial internal carotid artery or proximal middle cerebral artery who had last been known to be well 6 to 24 hours earlier and who had a mismatch between the severity of the clinical deficit and the infarct volume, thrombectomy was superior to control with respect to score on utility-weighted mRS at 90 days.
Reference
Raul G Nogueira, Ashutosh P Jadhav, Diogo C Haussen et al. Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct. N Engl J Med. 2018 Jan 4;378(1):11-21.
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