Bridging therapy bests direct endovascular thrombectomy for stroke management: DIRECT-SAFE trial

Australia: Direct endovascular thrombectomy is not non-inferior to standard bridging therapy (intravenous thrombolysis before endovascular thrombectomy) for stroke, reports DIRECT-SAFE trial data published in The Lancet. 

To date, the benefit of combined treatment with intravenous thrombolysis before endovascular thrombectomy in patients with acute ischaemic stroke caused by large vessel occlusion remains unclear. Acute ischemic stroke, a medical emergency caused by decreased blood flow to the brain, is a leading cause of death and disability each year.

Endovascular thrombectomy (EVT) has changed the landscape of acute stroke therapy and has become a standard treatment for acute ischemic stroke patients caused by a large vessel occlusion in the anterior circulation. To eliminate the confusion about the eligibility for IVT, it is important to determine the benefit and risk of direct EVT vs. EVT with prior IVT for patients with stroke.

Peter J., University of Melbourne, Australia, and his team conducted a study to determine that the clinical outcomes of patients with stroke with large vessel occlusion treated with direct endovascular thrombectomy within 4•5 h would be non-inferior when compared to those treated with standard bridging therapy (intravenous thrombolysis before endovascular thrombectomy).

Researchers recruited 295 patients, who presented within 4•5 h of stroke onset from 25 acute-care hospitals. Patients were assessed for large vessel occlusion to determine their eligibility and were randomly assigned to direct endovascular thrombectomy (n=148) or bridging therapy (n=147). The primary efficacy endpoint was functional independence defined as a modified Rankin Scale score of 0–2 or return to baseline at 90 days, with a non-inferiority margin of –0•1, analyzed by intention to treat (including all randomly assigned and consenting patients) and per protocol. The intention-to-treat population was included in the safety analyses.

Key findings of the study,

• Functional independence occurred in 55% of patients in the direct thrombectomy group and 61% of patients in the bridging therapy group.

• Safety outcomes were similar between both the groups, with symptomatic intracerebral hemorrhage occurring in 1% of patients in the direct group and 1% of patients in the bridging group.

• The death occurred in 15% of patients in the direct group and16% of patients in the bridging group.

The authors conclude that direct endovascular thrombectomy is not non-inferior to bridging therapy in stroke patients. The additional information from the present study may inform guidelines to recommend bridging therapy as standard treatment.

Reference:

Prof Bernard Yan, Prof Leonid Churilov, Richard J Dowling, Steven J Bush, Andrew Bivard, et al.  Published: July 09, 2022

DOI: https://doi.org/10.1016/S0140-6736(22)00564-5