Abstract Body: Background and aims: Two recent clinical trials (ATTENTION and BAOCHE) demonstrated superiority of endovascular therapy over medical management among patients with stroke due to basilar-artery occlusion within 24hours. The primary aim of this study is to evaluate the hypothesis that mechanical thrombectomy is superior to medical management alone in achieving favourable outcomes in subjects presenting with stroke due to basilar-artery occlusion in the extending time window of 24-72 hours from symptom onset.
Methods: A prospective, multi-center, randomized, controlled, open-label and blinded-endpoint trial. The randomization employs a 2:1 ratio of mechanical thrombectomy and best medical therapy (BMT) vs. BMT alone. Patients with posterior circulation acute ischemic stroke will be recruited if they were 18 to 80 years of age; had an occlusion of the basilar artery or intracranial segments of both vertebral arteries that could be treated within 24-72 hours after symptom onset; had a pre-stroke score of 0 or 1 on the modified Rankin scale (mRS); and had a score of 6 or higher on the National Institutes of Health Stroke Scale at presentation. The main exclusion criteria with regard to imaging were evidence of recent intracranial hemorrhage; had a large infarct in the posterior circulation, defined as PC-ASPECTS < 6 on computed tomography (CT), CT angiographic (CTA) source images, or diffusion-weighted magnetic resonance imaging (MRI); and the presence of a large infarct in the brain stem, defined as a Pons-Midbrain Index of more than 2 points.
The primary outcome will be the proportion of patients achieving modified Rankin Scale (mRS) 0–3 at 90 days. Key secondary outcomes are: ordinal (shift) mRS analysis at 90 days, dichotomized mRS score (0–2 vs. 3–6 and 0–4 vs. 5–6) at 90 days, vessel recanalization at 24 h in both treatment arms, and successful recanalization in the thrombectomy arm according to the modified thrombolysis in cerebral infarction (mTICI) classification defined as mTICI 2 b or 3. Safety variables are mortality at 90 days, symptomatic intracranial hemorrhage rates at 24 hours, and procedure-related complications.
Results: This trial is currently being prepared and will soon begin.
Conclusions: Results from this trial will indicate whether mechanical thrombectomy is superior to medical management alone in achieving favorable outcomes in subjects with acute stroke caused by basilar artery occlusion presenting within 24–72 hours from symptom onset.