ImportanceDL-3-n-butylphthalide (NBP) is a drug for treating acute ischemic stroke and may play a neuroprotective role by acting on multiple active targets. The efficacy of NBP in patients with acute ischemic stroke receiving reperfusion therapy remains unknown.ObjectiveTo assess the efficacy and safety of NBP in patients with acute ischemic stroke receiving reperfusion therapy of intravenous thrombolysis and/or endovascular treatment.Design, Setting, and ParticipantsThis multicenter, double-blind, placebo-controlled, parallel randomized clinical trial was conducted in 59 centers in China with 90-day follow-up. Of 1236 patients with acute ischemic stroke, 1216 patients 18 years and older diagnosed with acute ischemic stroke with a National Institutes of Health Stroke Scale score ranging from 4 to 25 who could start the trial drug within 6 hours from symptom onset and received either intravenous recombinant tissue plasminogen activator (rt-PA) or endovascular treatment or intravenous rt-PA bridging to endovascular treatment were enrolled, after excluding 20 patients who declined to participate or did not meet eligibility criteria. Data were collected from July 1, 2018, to May 22, 2022.InterventionsWithin 6 hours after symptom onset, patients were randomized to receive NBP or placebo in a 1:1 ratio.Main Outcomes and MeasuresThe primary efficacy outcome was the proportion of patients with a favorable outcome based on 90-day modified Rankin Scale score (a global stroke disability scale ranging from 0 [no symptoms or completely recovered] to 6 [death]) thresholds of 0 to 2 points, depending on baseline stroke severity.ResultsOf 1216 enrolled patients, 827 (68.0%) were men, and the median (IQR) age was 66 (56-72) years. A total of 607 were randomly assigned to the butylphthalide group and 609 to the placebo group. A favorable functional outcome at 90 days occurred in 344 patients (56.7%) in the butylphthalide group and 268 patients (44.0%) in the placebo group (odds ratio, 1.70; 95% CI, 1.35-2.14; P < .001). Serious adverse events within 90 days occurred in 61 patients (10.1%) in the butylphthalide group and 73 patients (12.0%) in the placebo group.Conclusions and RelevanceAmong patients with acute ischemic stroke receiving intravenous thrombolysis and/or endovascular treatment, NBP was associated with a higher proportion of patients achieving a favorable functional outcome at 90 days compared with placebo.Trial RegistrationClinicalTrials.gov Identifier: NCT03539445
Background To quantify the effectiveness and safety of the Trevo® Retriever for endovascular treatment of acute ischemic stroke (AIS) patients in China. Methods Trevo Retriever Registry (China) was a prospective, multicenter, non-comparative, open-label study of patients with AIS treated with the Trevo Retriever. The primary outcome was the proportion of patients achieving an expanded Thrombolysis in Cerebral Infarction (eTICI) score ≥2b at the end of endovascular treatment. Secondary outcomes included first-pass eTICI score ≥2b and 90-day modified Rankin Scale (mRS) score ≤2. Results The Trevo Retriever Registry (China) enrolled and followed 201 patients (62.1 ± 12.5 years-old; 70.6% male) at 11 centers. The pre-procedure NIHSS score and ASPECTS were 16 (interquartile range (IQR), 13–21) and 7 (IQR, 6–9), respectively, and 188 (93.5%) patients had an mRS score of 0 prior to the stroke. The main stroke etiology was large artery atherosclerosis, accounting for 71.6% (144/201) of patients. Post-procedure eTICI ≥2b was 98.4% (187/190). First-pass eTICI ≥2b was 74.7% (136/182). The 90-day good outcome (mRS ≤2) rate was 73.6% (148/201). The 90-day all-cause mortality was 5.5% (11/201). Neurological deterioration at 24 h post-procedure was observed in 7.7% (15/195) patients. Embolism in a new territory was seen in one patient (0.5%). Two (1.0%) procedure-related adverse events (AEs) occurred, which were intra-procedure cerebral artery embolism. No Trevo related AEs occurred. Conclusions This real-world study of the Trevo Retriever in China demonstrated a high rate of revascularization and first-pass success that resulted in an overall high good function outcome rate and low mortality.
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