目的大血管闭塞卒中患者的并发症或严重不良事件(SAEs)是常见的治疗方法。关于SAE对血管内血栓切除术(EVT)后患者的影响的研究有限。本研究的目的是表征EVT后SAE的发生率和临床影响。方法使用“DEVT”和“RESCUEBT”试验的汇总数据库进行事后分析。SAE被指定为有症状的颅内出血,脑疝或开颅手术,呼吸衰竭,循环衰竭,肺炎,深静脉血栓形成,全身出血.主要终点是功能独立性(90天内修改的Rankin量表评分0-2)。Logistic回归分析用于确定SAE与结局之间的预测因子和关联。结果在1182名患者中,402(34%)有手术并发症,745例(63%)发生了1404例严重不良事件,住院死亡率为4.65%。三种最常见的SAE是肺炎(620,52.5%),全身出血(174,14.7%)和呼吸衰竭(173,14.6%)。肺炎,全身性出血或深静脉血栓形成对生命的威胁较小.高龄患者(调整后的优势比,1.28[95%置信区间,1.14-1.43]),更高的NIHSS(1.09[1.06-1.11]),闭塞部位(大脑中动脉-M1与颅内脑动脉[ICA]:0.75[0.53-1.04];M2vs.ICA:1.30[0.80-2.12]),较长的手术时间(1.01[1.00-1.01])和不成功的血管再通(1.79[1.06-2.94])更有可能出现严重不良事件。与没有SAE相比,SAE患者的功能独立性几率较低(0.46[0.40-0.54]).总体结论,卒中患者血栓切除术后诊断的SAE很常见(超过60%),并与功能依赖相关。高龄患者,更高的NIHSS,较长的手术时间和失败的再通更有可能出现SAE.M1和M2闭塞患者与ICA闭塞患者的SAE风险无统计学差异。了解SAE的患病率和预测因素可以提醒临床医生EVT后患者SAE的估计风险。
OBJECTIVE: Complications or serious adverse events (SAEs) are common in the treatment of patients with large vessel occlusion stroke. There has been limited study of the impact of SAEs for patients after endovascular thrombectomy (EVT). The goal of this study was to characterize the rates and clinical impact of SAEs following EVT.
METHODS: A post hoc analysis was performed using pooled databases of the \"DEVT\" and \"RESCUE BT\" trials. SAEs were designated as symptomatic intracranial hemorrhage, brain herniation or craniectomy, respiratory failure, circulatory failure, pneumonia, deep venous thrombosis, and systemic bleeding. The primary endpoint was functional independence (modified Rankin scale score 0-2 within 90 days). Logistic regression analysis was used to determine the predictors and associations between SAEs and outcomes.
RESULTS: Of 1,182 enrolled patients, 402 (34%) had a procedural complication and 745 (63%) had 1,404 SAE occurrences with 4.65% in-hospital mortality. The three most frequent SAEs were pneumonia (620, 52.5%), systemic bleeding (174, 14.7%), and respiratory failure (173, 14.6%). Pneumonia, systemic bleeding, or deep venous thrombosis was less life-threatening. Patients with advanced age (adjusted odds ratio, 1.28 [95% confidence interval, 1.14-1.43]), higher NIHSS (1.09 [1.06-1.11]), occlusion site (middle cerebral artery-M1 vs. internal carotid artery [ICA]: 0.75 [0.53-1.04]; M2 vs. ICA: 1.30 [0.80-2.12]), longer procedure time (1.01 [1.00-1.01]), and unsuccessful vessel recanalization (1.79 [1.06-2.94]) were more likely to experience SAEs. Compared with no SAE, patients with SAEs had lower odds of functional independence (0.46 [0.40-0.54]).
CONCLUSIONS: Overall, SAEs diagnosed following thrombectomy in patients with stroke were common (more than 60%) and associated with functional dependence. Patients with advanced age, higher NIHSS, longer procedure time, and failed recanalization were more likely to experience SAEs. There was no statistical difference in the risk of SAEs among patients with M1 and M2 occluded compared with those ICA occluded. An understanding of the prevalence and predictors of SAEs could alert clinicians to the estimated risk of an SAE for a patient after EVT.