CTU Bern

SWIFT-DIRECT: Results published

12.07.2022 – Results of a global trial treatment on thrombectomy in stroke patients were published in The Lancet.

The randomized controlled trial SWIFT-DIRECT was designed to assess whether thrombectomy alone is non-

inferior to intravenous alteplase plus thrombectomy for treating acute stroke patients with large vessel occlusions. The primary outcome was functional independence at 90 days, defined as a score of ≤2 on the modified Rankin scale. An absolute risk difference of −12% was pre-specified as non-inferiority margin.

A total of 408 patients were randomized in 42 centers in Europe and Canada. Functional independence was reached by 114 (57%) assigned to thrombectomy alone and 135 (65%) assigned to IVT plus thrombectomy. Non-inferiority could not be demonstrated as the lower limit of the one-sided 95% confidence interval crossed the non-inferiority margin (−15.1%). On the other hand, successful reperfusion was less common in patients assigned to thrombectomy alone (n=182, 91% versus n=199, 96%). Evidence for a difference in further efficacy and safety outcomes was not found—symptomatic intracranial hemorrhage occurred in five patients undergoing thrombectomy alone and seven patients receiving IVT plus thrombectomy. Together, the results of the trial do not support omitting IVT before thrombectomy in the eligible patient population.

The trial was led by the Department of Neurology of the Inselspital. CTU Bern provided the trial database (Data Management), data checks (Central Data Monitoring) and performed the statistical analysis (Statistics and Methodology).

The paper and the media release are accessible below.