Abstract 90: Butylphthalide Improves Functional Outcome In Patients With Acute Ischemic Stroke Receiving Intravenous Thrombolysis And/or Endovascular Treatment In Comparison To Placebo

Abstract

Introduction: Butylphthalide is a cerebro-protection drug that was originally extracted from seeds of Apium graveolens. Pre-clinical experiments have shown the cerebro-protective effect of Butylphthalide in animal models of ischemia-reperfusion. This study evaluated whether Butylphthalide can improve the functional outcome in acute ischemic stroke patients who receive intravenous recombinant tissue plasminogen activator (rt-PA) and/or endovascular treatment (EVT) compared to placebo. Methods: In the randomized, double-blinded, placebo-controlled trial, we enrolled patients with acute ischemic stroke who received intravenous rt-PA and/or EVT in 59 centers. Patients were randomized in a 1:1 ratio to receive either Butylphthalide or placebo daily for 90 days, including 14 days of intravenous injections and 76 days of oral capsules. All trial personnel and patients were masked to treatment allocation. The primary outcome was an adjusted favorable outcome at 90 days after randomization, defined as a score of 0 on the modified Rankin Scale (mRS) in patients with a baseline score of 4-7 on the National Institutes of Health Stroke Scale (NIHSS); an mRS score of 0-1 in patients with a baseline NIHSS score of 8-14; and an mRS score of 0-2 in patients with a baseline NIHSS score of 15-25. Secondary outcomes included symptomatic intracranial hemorrhage, recurrent stroke and mortality. The analysis was done in the intention-to-treat population and in subgroups of age, sex, baseline NIHSS score, hypertension, and reperfusion treatment methods. This trial is registered with ClinicalTrials.gov, NCT03539445. Results: Between July 1, 2018 and 19 February, 2022, 1216 patients were enrolled, with 607 assigned to the butylphthalide group and 609 to the placebo group. The primary outcome of a favorable outcome on day 90 occurred in 344 patients (56.7%) in the butylphthalide group and 268 patients (44.0%) in the placebo group (OR, 1.70; 95% CI, 1.35 to 2.14; P <0.001). Secondary outcomes were similar between groups. There was no evidence of treatment modification effect in the subgroups. Conclusions: In conclusion, Butylphthalide improved favorable clinical outcome compared with placebo in patients with acute ischemic stroke receiving intravenous rt-PA and/or EVT.