Abstract Body: Background and aims: There are no randomized trials examining the best treatment for acute basilar artery occlusion with large Infarct. The primary aim of this study is to assess the safety and efficacy of thrombectomy for stroke due to basilar artery occlusion in patients with large infarct within 24 hours from symptom onset.
Methods: This is a prospective, multi-center, randomized, controlled, open-label and blinded-endpoint trial involving patients with acute basilar-artery occlusion and a posterior circulation Acute Stroke Prognosis Early CT score (pc-ASPECTS) of 3 to 5 (range, 0 to 10, with lower values indicating larger infarction). The randomization employs a 1:1 ratio of mechanical thrombectomy and best medical therapy (BMT) vs. BMT alone. The main exclusion criteria with regard to imaging were evidence of recent intracranial hemorrhage; and the presence on CT, CTA source images, or MRI of a large infarct in the brain stem, defined as a Pons-Midbrain Index of more than 3 points (range, 0 to 8, with higher values indicating more infarct burden; 1 point is attributed to infarction of <50% and 2 points to infarction of ≥50% on one side of the pons or midbrain). 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 hours 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 outcomes 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 plus best medical management is superior to best medical management alone in achieving favorable outcomes in subjects with large infarct stroke caused by basilar artery occlusion presenting within 24 hours from symptom onset.