颅内椎基底动脉干大动脉瘤血管内介入与保守治疗的对照研究

Comparative study of interventional and conservative treatment of intracranial vertebrobasilar artery trunk large aneurysms

目的与保守治疗比较,评估介入治疗颅内椎基底动脉干大动脉瘤的安全性和有效性。方法本研究为前瞻性两个中心队列研究,资料来源于中国人民解放军火箭军特色医学中心和河南省人民医院,2012年10月至2018年10月共纳入69例颅内椎基底动脉干大动脉瘤(最大径>10 mm)患者。治疗方案由医生根据患者病情与患者商议后确定,分为血管内介入治疗(手术组)和保守治疗(保守组)。观察术后即刻及随访期两组患者的疗效及病死、卒中、其他部位出血、心肌梗死等在内的严重不良事件的发生率。采用χ2检验比较两组患者不良事件发生率。结果共纳入69例患者,手术组51例,接受血管重构介入治疗36例、血管解构介入治疗11例、二者联合介入治疗4例;保守组18例,接受单纯危险因素控制11例、危险因素控制联合抗血小板治疗7例。保守组的高血压患者占94.4%(17/18)、巨大型动脉瘤占50.0%(9/18),分别高于手术组的64.7%(33/51,χ2=4.500,P=0.034)、19.6%(10/51,χ2=4.730,P=0.030)。与疾病相关的总的严重不良事件发生率手术组15.7%(8/51)、保守组44.4%(8/18),危险比(RR)值0.353[95%可信区间(CI):0.156~0.801],两组差异有统计学意义(χ2=4.668,P=0.031)。相关病死率手术组2.0%(1/51)、保守组38.9%(7/18),RR值0.050(95%CI:0.007~0.382),两组差异有统计学意义(χ2=14.281,P<0.001);疾病相关出血性卒中发生率手术组2.0%(1/51)、保守组22.2%(4/18),RR值0.088(95%CI:0.011~0.738),两组差异有统计学意义(χ2=5.391,P=0.020)。手术组44例患者获得影像随访,中位随访时间6个月,动脉瘤治愈率56.8%(25/44),保守组9例获得影像随访,中位随访时间12个月,无动脉瘤治愈患者,差异有统计学意义(χ2=7.534,P=0.006)。结论与保守治疗相比,血管内介入治疗颅内椎基底动脉干大动脉瘤有较低的严重不良事件发生率、病死率。

Objective To evaluate the safety and efficacy of endovascular interventional treatment of the intracranial vertebrobasilar trunk large aneurysms(VBTLAs)compared with conservative treatment.Methods This is a prospective multi-center cohort study.From October 2012 to October 2018,a total of 69 patients with intracranial vertebrobasilar trunk large aneurysm(diameter>10 mm)from Henan Province People's Hospital and People's Liberation Army Rocket Medical Center were included in this study.Patients themselves chose either endovascular interventional therapy(interventional group)or conservative treatment(conservative group)after discussion with their doctors.Theχ2 test was used to compare the incidence of deaths,stroke,and all other serious adverse events including other site bleeding,myocardial infarction and others between the two groups.Results A total of 69 patients were enrolled,of whom 51 patients were enrolled in interventional group,18 patients underwent endovascular reconstructive therapy,11 patients underwent deconstructive therapy,and 4 patients underwent conjunction interventional treatments.Eighteen patients were enrolled in conservative group,of whom 11 cases received simple risk factor control,7 cases received antiplatelet and risk factors control.The proportions of hypertensive patients 94.4%(17/18)and giant aneurysms 50.0%(9/18)in the conservative group were higher than those in the surgery group 64.7%(33/51,χ2=4.500,P=0.034),19.6%(10/51,χ2=4.730,P=0.030).The incidence of all serious adverse events associated with protocol was 15.7%(8/51)in the interventional group and 44.4%(8/18)in the conservative group[risk ratio(RR)=0.353,95%confidence intervals(CI):0.156-0.801],and the difference was significant(χ2=4.668,P=0.031).The incidence of fatal events associated with protocol was 2.0%(1/51)in the interventional group and 38.9%(7/18)in the conservative group(RR=0.050,95%CI:0.007-0.382),and the difference was significant(χ2=14.281,P<0.001).The incidence of hemorrhage events associated with protocol was 2.0%(1/51)in the interventional group and 22.2%(4/18)in the conservative group(RR=0.088,95%CI:0.011-0.738),and the difference was significant(χ2=5.391,P=0.020).Follow-up imaging showed that the occlusion rate of aneurysms in 44 patients in the interventional group was 56.8%(25/44)after a median follow-up of 6 months.Imaging follow-up was obtained in 9 patients,whose occlusion rate of aneurysms was 0 and the median follow-up time was 12 months,in the conservative group.The difference was significant(χ2=7.534,P=0.006).Conclusion Compared with conservative treatment,endovascular intervention of the intracranial VBTLAs has lower incidences of serious adverse events and death events.