By Antonella Macerollo
For July 2021, we have selected: Langezaal LCM et al. Endovascular Therapy for Stroke Due to Basilar-Artery Occlusion. N Engl J Med 2021; 384:1910-1920. DOI: 10.1056/NEJMoa2030297
It is well known that 10% of all ischaemic strokes are caused by the intracranial proximal occlusion of the basilar-artery, causing high morbidity and mortality. Therefore, there is a current need to understand whether specific treatments, such as endovascular therapy, are associated with higher clinical outcomes compared with standard medical care.
Our research paper of the month is a multicentre (23 centres in 7 countries), open-label, international, randomised (ratio 1:1), controlled trial with blinded outcome assessment, comparing endovascular therapy vs medical therapy in a sample of 300 patients with basilary artery occlusion, recruited from 2011 to 2019. Patients were randomly assigned within six hours after the estimated time of onset of a stroke due to basilar-artery occlusion, in a 1:1 ratio, to receive endovascular therapy (n=154) or standard medical care (n=146).
Inclusion criteria were: acute features of basilar-artery territory ischaemia, a proven basilar-artery occlusion on computed tomographic angiography or magnetic resonance angiography, and contraindications to intravenous thrombolysis.
Exclusion criteria were: presence of intracranial haemorrhage; extensive, bilateral brainstem infarction on CT; cerebellar mass effect; and acute hydrocephalus evident on neuroimaging.
The primary outcome was a favourable functional outcome (modified Rankin scale =0-3) at 90 days.
The primary safety outcomes were symptomatic intracranial haemorrhage within three days after the initiation of treatment and mortality at 90 days.
Intravenous thrombolysis was used in 78.6% of the endovascular group patients and in 79.5% of the medical group patients.
Langezaal et al found that 44.2% of the endovascular group patients showed a favourable functional outcome versus 37.7% in the medical care group (risk ratio, 1.18; 95% confidence interval [CI], 0.92 to 1.50).
Symptomatic intracranial haemorrhage occurred in 4.5% of the patients after endovascular therapy and in 0.7% of those after medical therapy (risk ratio, 6.9; 95% CI, 0.9 to 53.0); whereas the mortality at 90 days was 38.3% and 43.2%, respectively (risk ratio, 0.87; 95% CI, 0.68 to 1.12). There were not statistically significant differences between the two groups.
Overall, our authors of the month did not find that the endovascular therapy had a significantly higher efficacy compared to the medical therapy in stroke patients with basilar-artery occlusion. However, the primary outcome results showed a wide confidence interval, suggesting that it is not possible to exclude a substantial benefit of endovascular therapy with this trial. Conclusive results on the efficacy and safety of endovascular therapy for basilar-artery occlusion might be achievable with larger trials.