A Comparative Study On The The Efficacy And Safety Of Two Kinds Of Thrombectomy Stents In Patients With Acute Ischemic Stroke

Background and Objectives:Stroke has become one of the most important diseases around the world due to its high morality rate and disability rate.The incidence of stroke has been increasing by millions each year in China,among which acute ischemic stroke(AIS)accounts for nearly 80%of all stroke populations,and intracranial or extracranial vessel occlusion is currently considered the predominant etiology of AIS.Early recanalization of the occluded vessels is the most direct and effective treatment.The early treatment goal of AIS is to rescue the ischemic penumbra brain area and minimize the infarct brain tissue area by restoring the blood flow through recanalizing the occluded blood vessels.At present a variety of approaches can be applied for the treatment of AIS including intravenous thrombolysis and intra-vascular intervention characterized by mechanical embolectomy.However,traditional intravenous thrombolysis is restrained by it short treatment time window,low recanalization rate,high haemorrhagic transformation risk,poor prognosis and more contraindications.Several large clinical studies indicates that embolectomy is a safe approach and showed a higher recanalization rate and a better neurologic function improvement.The 2015 American ASA/AHA guideline and Chinese guidelines recommend mechanical thrombectomy as the first-line treatment for acute phase AIS treatment.Solitaire retractable stent and Trevo retrievable stent are second-generation cdevices approved by the FDA for clinical treatment of acute stroke.Both types of stents have their own figures and are currently used in clinical practice worldwide,but few studies have directly and systematically compared the two types of stents.Trevo stent entered the Chinese market in 2015 but has not yet been widely used in China,thus leaves the clinical benefits of Trevo stent in China unclear so far.This study aims to compare the safety and efficacy of Solitaire and Trevo retrievable stent.Methods:We retrospectively analyzed a total of 181 patients administered from January 2014 to December 2018 in the Second Affiliated Hospital of the Chinese People’s Liberation Army Military Medical University and 14 other comprehensive stroke centers.The occluded blood vessels were internal carotid artery and M1 segment of middle cerebral artery.All patients underwent thrombectomy using Solitaire retrievable stent or Trevo retrievable stent during 6 hours after onset.Patients were divided into two groups according to each participants’intention:Solitaire group(138 cases)and Trevo group(43 cases).Baseline data were compared between the two groups(including gender,age,past history(gender,age,history of hypertension,history of diabetes,history of hyperlipidemia,history of atrial fibrillation,history of stroke,history of TIA,history of smoking,history of drinking,systolic blood pressure at admission,randomized blood glucose,total cholesterol,Low-density lipoprotein,ASPECT score,collateral circulation score,NIHSS score at onset,onset to visit time,onset to vascular recanalization time).To compare the effectiveness and safety of two different thrombectomy stents,the primary efficacy endpoint was 90-day mRS score and safety endpoint was symptomatic intracranial hemorrhage and death.Results:1.Comparison of mechanical thrombectomy in patients with different thrombectomy stents for occlusion vessel opening:There was no significant difference in the successful rate of mechanical thrombectomy between the two groups(62.3%in the Solitaire group and67.4%in the Trevo group,χ~2=0.371,P=0.542);balloon dilation(Solitaire group 18.1%vs Trevo group 25.6%,χ~2=1.147,P=0.282)or stent implantation(Solitaire group 23.2%vs Trevo group 16.3%,χ~2=0.926,P=0.336)or arterial administration of tirofiban(11.0%in the Solitaire group vs 9.3%in the Trevo group,χ~2=0.532,P=0.466).There was no statistically significant difference between the two groups in remedial treatment.The levels of mTICI blood flow≥2b between the two groups after remedial treatment(84.1%in the Solitaire group,86.0%in the Trevo group,χ~2=0.099,P=0.753)were not significantly different.2.Comparison of neurological function improvement between the two groups:In the Solitaire group,the proportion of 90-day mRS scores of 0-2 and 3-6 were 47.8%and 52.2%,respectively.The proportion of 90-day mRS scores of 0-2 and 3-6 in the Trevo group were44.2%and 55.8%,with no statistical difference between the groups(Z=0.416,p=0.677);3.Comparison of the safety of mechanical thrombectomy in patients with different thrombectomy stents:The mortality rate and the postoperative symptomatic intracranial hemorrhage rate was 9.4%,and 8.0%in the Solitaire group,and in the Trevo group’morality was 7.0%and was 9.3%.There was no significant difference between the two groups(χ~2=0.243,0.063,P=0.622,0.802).The incidence of subarachnoid hemorrhage in the two groups(2.9%in the Solitaire group vs.4.7%in the Trevo group)and the incidence of arterial perforation(1.4%in the Solitaire group vs.7.0%in the Trevo group)was not statistical different(χ~2=0.010,1.955,P=0.922,0.162).Conclusions:In the treatment of acute ischemic stroke patients with intracranial artery and middle cerebral artery M1 occlusion undergoing mechanical thrombectomy,Solitaire retrievable thrombectomy stent and Trevo retrievable thrombectomy stent showed equal efficacy and safety,and both significantly improved the neurological prognosis of patients.