Efficacy and safety of domestic RECO flow restoration device in acute intracranial large-vessel occlusion / 中华神经医学杂志

ABSTRACT

Objective:To explore the efficacy and safety of domestic RECO flow restoration device in acute intracranial large-vessel occlusion (LVO).Methods:This study was a multicenter, prospective, randomized, open, controlled trial; 136 patients with acute intracranial LVO at 7 Chinese stroke centers from February 2014 to August 2016 were randomly assigned into an experimental group (thrombectomy by RECO device, n=67) and a control group (thrombectomy by Solitaire device, n=69). The efficacy and safety of patients from the two groups were compared and analyzed. The primary efficacy end point was set as achievement of good recanalization (modified thrombolysis in cerebral infarction [mTICI] grading≥2); the secondary efficacy end points included good prognosis (modified Rankin scale scores≤2 90 d after thrombectomy), time from puncture to achieving good recanalization/time from puncture to final angiogram on condition that good recanalization was not gained, or mortality within 90 d of thrombectomy. The safety end points included any device-related serious adverse events, symptomatic intracerebral hemorrhage or serious adverse events within 24 of thrombectomy. Results:There was no statistically significant difference between the experimental group and the control group in successful rate of good recanalization (91.0% vs. 86.9%), good prognosis rate (62.7% vs. 46.4%), time from puncture to achieving good recanalization/time from puncture to final angiogram on condition that good recanalization was not gained([85.4±47.0] min vs. [89.9±53.3] min), and mortality within 90 d of thrombectomy (13.4% vs. 23.2%, P>0.05). There were no device-related serious adverse events in all patients. No significant differences were found in the incidences of symptomatic intracranial hemorrhage (1.5% vs. 7.4%) or serious adverse events (death [1.5% vs. 1.4%] and brain hernia [4.5% vs. 0.0%]) between the two groups ( P>0.05). Conclusion:The domestic RECO flow restoration device is an effective and safe mechanical thrombectomy stent retriver for acute intracranial LVO.