Direct Transfer To Angiography Suite In Severe Acute Stroke

Key Takeaways

• In the intention-to-treat analysis, direct transfer was not associated with better 90-day functional independence than the conventional pathway.
• Symptomatic intracranial haemorrhage was reported more often with direct transfer, while 90-day mortality was not significantly different between groups.
• The multicenter randomized comparison across ten French comprehensive stroke centers in thrombectomy candidates was stopped early for safety.

In the DIRECT ANGIO trial, direct transfer to the angiography suite was not associated with higher 90-day functional independence than a conventional imaging-first pathway, and symptomatic intracranial haemorrhage occurred more often with direct transfer. The randomized comparison focused on patients arriving at endovascular-capable centers with clinical features highly suggestive of large-vessel occlusion. It asked whether bypassing initial imaging could shorten in-hospital stroke workflow for thrombectomy candidates with severe acute neurological deficit. The steering committee later stopped the trial after unmasking and reviewing the data.

Researchers conducted a multicenter, open-label, blinded-endpoint randomized controlled trial in ten comprehensive stroke centers in France. Adults aged 85 years or younger were enrolled within 5 hours of symptom onset if they met ASND-LVO criteria. Eligibility required unilateral motor deficit with an NIHSS score of at least 5 plus a cortical symptom scoring at least 1. Randomization used a web-based system and compared immediate suite transfer with imaging followed by endovascular transfer when indicated. Patients were assigned 1:1 to direct transfer or to conventional imaging followed by angiography-suite transfer if eligible, with 115 randomized overall, 57 and 58 respectively. The direct-transfer pathway was intended to accelerate in-hospital workflow.

The prespecified primary outcome was functional independence, defined as a modified Rankin Scale score of 0 to 2 at 90 days in the intention-to-treat population. This analysis kept patients in their assigned groups regardless of final diagnosis, imaging findings, or treatments received. Functional independence occurred in 20 of 56 patients, or 36%, after direct transfer and in 22 of 53, or 42%, with conventional care. The adjusted odds ratio was 0.73, with a 95% confidence interval of 0.32 to 1.69. These results did not show a beneficial difference in 90-day functional outcome with direct transfer.

The main safety outcomes were symptomatic intracranial haemorrhage and all-cause mortality at 90 days. Symptomatic intracranial haemorrhage occurred in five of 34 patients, or 15%, with direct transfer and in zero of 42 with conventional care, giving an adjusted odds ratio of 11.0. The 95% confidence interval for that estimate was 1.28 to 1406. All-cause mortality was 10 of 56, or 18%, versus 6 of 53, or 11%, with an adjusted odds ratio of 1.65 and a 95% confidence interval of 0.52 to 5.55, without a significant difference.

Enrollment ran from July 9, 2020, to April 18, 2023, and an interim analysis occurred on Sept 27, 2023. After unmasking and reviewing the data, the steering committee permanently stopped the trial on Dec 1, 2023, for safety reasons. The authors noted that early stopping and the small sample size limited the precision of the effect estimates.