DAWN.
| Study characteristics | ||
| Methods | International, multicentre, prospective, randomised, open‐label trial with blinded assessment of endpoints | |
| Participants | Patients were eligible for inclusion if they had evidence of occlusion of the intracranial internal carotid artery, the first segment of the middle cerebral artery, or both on CTA or MRA. They also needed to have a clinical/radiological mismatch between the severity of the clinical deficit and the infarct volume. Patients must have clinical signs and symptoms consistent with the diagnosis of an acute ischaemic stroke, and belong to 1 of the following subgroups: patient has failed IV t‐PA therapy (defined as a confirmed persistent occlusion 60 min after administration); patient is contraindicated for IV t‐PA administration. Age ≥ 18 years Baseline NIHSS ≥ 10 (assessed within 1 hour prior to measuring core infarct volume) Patient can be randomised between 6 and 24 hours after time last known well. No significant pre‐stroke disability (pre‐stroke mRS must be 0 or 1) Infarction < 1/3 MCA territory involved, as evidenced by CT or MRI |
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| Interventions | Thrombectomy (treatment group) versus standard medical care (control group) | |
| Outcomes | Primary endpoint was mean score of mRS at 90 days. | |
| Notes | Funding source: Stryker Neurovascular. Terminated prematurely due to efficacy | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was central and a web‐based procedure with block minimisation to balance the 2 treatment groups, and was stratified according to mismatch criteria, the interval between the time that the participant was last known to be well and randomisation. |
| Allocation concealment (selection bias) | Low risk | Web‐based randomisation |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Open‐label trial |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded assessment of endpoints |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No participants lost to follow‐up |
| Selective reporting (reporting bias) | Low risk | No participants lost to follow‐up, and intention‐to‐treat analysis provided |
| Other bias | Low risk | At 31 months and 206 participants enrolled, the trial was stopped because of the results of a prespecified interim analysis. Adaptive trial design with sample size from 150 to 500 participants |