In 2022, several clinical trials have answered important research questions about revascularisation, and about the indications for endovascular thrombectomy, but their answers have raised additional questions. For example, two multicentre, open-label, randomised trials (DIRECT-SAFE and SWIFT-DIRECT) compared endovascular thrombectomy alone with combined intravenous thrombolysis and endovascular thrombectomy to find out if intravenous alteplase could be withheld in patients with large vessel occlusion who present directly to a hospital at which endovascular thrombectomy can be done (referred to as mothership patients). These trials did not show non-inferiority of endovascular thrombectomy alone with respect to the primary outcome of functional independence (defined as a modified Rankin Scale [mRS] score of 0–2), with adjusted risk differences of –0·051 (95% CI –0·160 to 0·059) in DIRECT-SAFE and –7·3 (95% CI –16·6 to –2·1) in SWIFT-DIRECT. However, some uncertainty surrounding these findings remains because the non-inferiority margins chosen in DIRECT-SAFE (10%) and SWIFT-DIRECT (12%) varied from those in previous trials that investigated the same research question, and the odds ratio bounds were higher. Overall, DIRECT-SAFE and SWIFT-DIRECT show that intravenous alteplase should not be withheld when endovascular thrombectomy is being done in a mothership setting. However, the findings raise questions about whether there should be guidelines about an acceptable non-inferiority threshold, and who should contribute to these guidelines (doctors, patients, or policymakers)?1

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References

  1. Goyal, M., Singh, N., & Ospel, J. (2023). Clinical trials in stroke in 2022: new answers and questions. The Lancet Neurology, 22(1), 9–10. https://doi.org/10.1016/s1474-4422(22)00488-4

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