Safety and efficacy of direct versus conventional transfer to angiography suite in patients with severe acute stroke treated with thrombectomy (DIRECT ANGIO) in France: a multicentre, open-label, blinded-endpoint, randomised controlled trial

Abstract

Background

Direct transfer to angiography suite (DTAS) for patients with suspected stroke primarily admitted to an endovascular-capable centre could accelerate in-hospital workflow and improve outcome. We aimed to assess the safety and efficacy of DTAS for patients with acute severe neurological deficit highly suggestive of ischaemic stroke due to a large vessel occlusion (ASND-LVO).

Methods

We did an open-label, multicentre, randomised controlled trial in ten comprehensive stroke centres in France. We enrolled adult patients (age ≤85 years) with ASND-LVO (unilateral motor deficit with a score ≥5 plus a cortical symptom with a score ≥1 based on the National Institues of Health Stroke Scale) admitted within 5 h of symptom onset. Patients were randomly assigned (1:1) with a web-based system to DTAS or conventional pathway (ie, imaging followed by transfer to the angiography suite for endovascular treatment if eligible). The primary outcome was functional independence defined as a modified Rankin Scale score 0 to 2 at 90 days in the intention-to-treat population—ie, all randomly assigned patients in their originally assigned treatment groups, irrespective of diagnosis, imaging findings, or treatments received. Symptomatic intracranial haemorrhage and all-cause mortality at 90 days were the main safety outcomes. This study was registered on ClinicalTrials.gov (NCT03969511).

Findings

Between July 9, 2020, and April 18, 2023, 115 patients were randomly assigned to the DTAS group (n=57) or the conventional group (n=58). An interim analysis was done on Sept 27, 2023. The trial steering committee permanently stopped the trial on Dec 1, 2023, for safety reasons after unmasking and analysis of the data. In the intention-to-treat analysis, the risk of symptomatic intracranial haemorrhage was increased in the DTAS group compared with the conventional group (five [15%] of 34 vs zero [0%] of 42; adjusted odds ratio [OR] 11·0 [95% CI 1·28–1406]). All-cause mortality did not differ significantly between groups (ten [18%] of 56 vs six [11%] of 53; adjusted OR 1·65 [95% CI 0·52–5·55]). Functional independence was reached in 20 [36%] of 56 participants in the DTAS group vs 22 [42%] of 53 in the conventional group (adjusted OR 0·73 [95% CI 0·32–1·69]).

Interpretation

DTAS for patients with ASND-LVO was associated with an increased risk of symptomatic intracranial haemorrhage without evidence of a beneficial effect on functional outcome at 90 days. However, because the trial was stopped early for safety reasons, the small sample size limits the precision of the effect estimates on the primary outcome and all secondary and safety outcomes. Therefore, further clinical trials are required to firmly conclude on the safety and efficacy of DTAS for patients with suspected acute ischaemic stroke due to a large vessel occlusion.

Funding

French Ministry of Health and Medtronic.