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BackgroundMechanical thrombectomy is the standard treatment for acute ischemic stroke (AIS) with large vessel occlusion (LVO) in the anterior circulation. This trial aimed to indicate whether Skyflow, a new thrombectomy device, could achieve the same safety and efficacy as Solitaire FR in the treatment of AIS.MethodsThis study was a prospective, multicenter, randomized, single blind, parallel, positive controlled, non-inferiority clinical trial. Patients with intracranial anterior circulation LVO within 8 hours from onset were included to receive thrombectomy treatment with either the Skyflow or Solitaire FR stent retriever. The primary endpoint was the rate of successful reperfusion (modified Treatment In Cerebral Infarction (mTICI) ≥2b) after the operation. The safety endpoints were the rate of symptomatic intracranial hemorrhage (sICH) and subarachnoid hemorrhage (SAH) at 24 hours after operation.ResultsA total of 95 and 97 patients were involved in the Skyflow group and Solitaire FR group, respectively. A successful reperfusion (mTICI ≥2b) was finally achieved in 84 (88.4%) patients in the Skyflow group and 80 (82.5%) patients in the Solitaire FR group. Skyflow was non-inferior to Solitaire FR in regard to the primary outcome, with the criterion of a non-inferiority margin of 12.5% (p=0.0002) after being adjusted for the combined center effect and the National Institutes of Health Stroke Scale (NIHSS) score. The rate of periprocedural sICH and SAH did not differ significantly between the two groups.ConclusionEndovascular thrombectomy with the Skyflow stent retriever was non-inferior to Solitaire FR with regard to successful reperfusion in AIS due to LVO (with a pre-specified non-inferiority margin of 12.5%).

Background and purpose Tirofiban administration after mechanical thrombectomy (MT) remains controversial. This study aimed to investigate the efficacy and safety of adjunct tirofiban treatment following MT for acute ischemic stroke (AIS) patients with large vessel occlusion (LVO) that resulted in successful reperfusion on digital subtraction angiography (DSA).Methods This retrospective study was conducted in Zhengzhou University University People's Hospital, an advanced stroke center in China. Consecutive patients with AIS who underwent endovascular therapy (EVT) were enrolled from June 2018 to January 2022. The safety endpoints were symptomatic intracerebral hemorrhage (sICH), total intracranial hemorrhage (ICH), and 3-month mortality. The efficacy endpoints were 3-month modified Rankin scale (mRS) score and 24-h neurological improvement.Results A total of 145 consecutive patients with AIS who underwent MT were analyzed, of whom 51 (35.2%) patients were in the tirofiban group. There were 30 (20.7%) patients with sICH, 50 (34.5%) patients suffered from ICH within 24-h post-MT, and 47 (32.4%) dead at 3-month. Besides, 31 (21.4%) patients achieved excellent clinical outcomes (mRS, 0-1), and 24-h neurological improvement was found in 29 (20.0%) patients. No statistically significant differences were found in safety outcomes on sICH, total ICH, and 3-month mortality, as well as efficacy outcomes on 3-month mRS scores (0-1) and 24-h neurological improvement between the two groups (P> 0.05 for all). Additionally, tirofiban was associated with 3-month mRS scores of 0-2 (adjusted odds ratio (OR), 3.75; 95% confidence interval (CI), 1.41–10.02, P= 0.008).Conclusion Adjunct tirofiban treatment following MT for AIS patients with LVO that resulted in successful reperfusion on DSA was not correlated with the increased risk of safety endpoints on sICH, ICH, and 3-month mortality, and it may be associated with a lower 3-month mRS score.