Head positioning after endovascular therapy for acute stroke due to large vessel occlusion (HeadSOAR): multicentre randomised controlled trial

OBJECTIVE: To determine whether an elevated head position (30-40°) improves functional outcomes compared with a flat head position (0-10°) in patients with acute ischaemic stroke caused by anterior circulation large vessel occlusion who have achieved successful reperfusion after endovascular thrombectomy. DESIGN: Multicentre, prospective, randomised, open label, blinded endpoint clinical trial. SETTING: 67 comprehensive stroke centres in China, between 16 November 2023 and 23 January 2025. PARTICIPANTS: 1368 adults (aged ≥18 years) with acute ischaemic stroke caused by anterior circulation large vessel occlusion who achieved successful endovascular reperfusion, defined as an expanded thrombolysis in cerebral infarction score ≥2b after endovascular thrombectomy. INTERVENTIONS: The primary outcome was functional status at 90 days after randomisation, assessed by shift analysis of scores on the modified Rankin scale (range 0-6). The primary safety outcome was all cause mortality at 90 days after randomisation. Efficacy analyses used the randomised, full analysis set, and safety analyses used the safety population (identical to the randomised population). Adjusted models included age, baseline National Institutes of Health Stroke Scale score (NIHSS), baseline Alberta Stroke Programme Early Computed Tomography Score, occlusion site, and time from last known well (ie, the last time when the patient was known to be at their usual neurological baseline before the current stroke event) to randomisation. RESULTS: In the population of 1368 randomised patients, the median age was 68 years, 565 participants (41.3%) were women, and 1358 (99.3%) completed the 90 day follow-up. The median baseline NIHSS score was 15, the median 90 day modified Rankin scale score was 3 (interquartile range (IQR) 1-5) in the head elevation group versus 3 (IQR 1-5) in the flat head position group (adjusted generalised odds ratio for a lower level of disability 1.12, 95% confidence interval (CI) 0.97 to 1.29, P=0.14). All cause mortality at 90 days occurred in 125 (18.3%) of 682 patients in the elevated head position group and 137 (20.3%) of 676 patients in the flat head position group (adjusted risk ratio 0.86, 95% CI 0.69 to 1.07, P=0.18). CONCLUSIONS: 72 hours of head elevation did not significantly improve 90 day functional outcomes versus flat head positioning in patients who had acute ischaemic stroke from large vessel occlusion with successful reperfusion after thrombectomy. The smaller than expected difference in results between the two groups leaves open the possibility of a modest but clinically meaningful benefit of head elevation in these patients. TRIAL: ClinicalTrials.gov NCT06115707.