真实世界中接受取栓治疗的脑卒中患者与临床试验队列存在差异：一项前瞻性观察性研究。
Stroke patients treated by thrombectomy in real life differ from cohorts of the clinical trials: a prospective observational study.
机构信息
Department of Neurology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246, Hamburg, Germany.
Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
出版信息
BMC Neurol. 2020 Mar 5;20(1):81. doi: 10.1186/s12883-020-01653-z.
BACKGROUND
Randomized controlled trials (RCTs) demonstrated efficacy and safety of endovascular treatment (ET) in anterior circulation large vessel occlusions (LVO). We aimed at investigating how stroke patients treated by thrombectomy in clinical practice and their outcome compare to cohorts and results of thrombectomy trials.
METHODS
In a prospective study, we consecutively included stroke patients treated by thrombectomy (2015-2017). Baseline characteristics, procedural and outcome data were analyzed. Outcome was assessed by modified Rankin Scale (mRS) at 90 days. Ordinal regression analysis was performed to identify predictors of outcome.
RESULTS
Thrombectomy was applied in 264 patients (median 75 years, 49.6% female). Median baseline National Institutes of Health Stroke Scale (NIHSS) was 16, 58.0% received concomitant intravenous thrombolysis, 62.1% were referred from external hospitals. Median Alberta Stroke Program Early CT Score (ASPECTS) was 7. Successful recanalization (modified Thrombolysis in Cerebral Infarction Score, mTICI 2b/3) was achieved in 72.0%. Symptomatic intracranial hemorrhage (sICH) occurred in 4.5%. Independent outcome (mRS 0-2) was achieved in 26.2%, poor outcome (mRS 5-6) in 49.2%. Only 33.5% met the stringent enrolment criteria of previous RCTs. Lower age, baseline NIHSS, pre-stroke mRS, higher ASPECTS, and successful recanalization were independent predictors of favourable outcome.
CONCLUSIONS
The majority of stroke patients treated by ET in clinical practice would not have qualified for randomization in prior RCTs. Outcome in real-life patient cohorts is worse than in the highly selected cohorts from randomized trials, while rates of successful recanalization, sICH and outcome predictors are the same. Our findings support ET in broader patient populations than in the RCTs and may improve treatment decision in individual stroke patients with LVO in clinical practice.
背景
随机对照试验（RCT）证明了血管内治疗（ET）在前循环大血管闭塞（LVO）中的疗效和安全性。我们旨在研究在临床实践中接受血栓切除术治疗的卒中患者及其结局与试验队列和结果相比如何。
方法
在一项前瞻性研究中，我们连续纳入了接受血栓切除术治疗的卒中患者（2015-2017 年）。分析了基线特征、手术过程和结局数据。通过改良 Rankin 量表（mRS）在 90 天评估结局。采用有序回归分析确定结局的预测因素。
结果
264 例患者接受了血栓切除术（中位年龄 75 岁，49.6%为女性）。中位基线国立卫生研究院卒中量表（NIHSS）为 16，58.0%接受了静脉溶栓治疗，62.1%为外院转来。中位 Alberta 卒中项目早期 CT 评分（ASPECTS）为 7。成功再通（改良脑梗死溶栓评分 mTICI 2b/3）率为 72.0%。症状性颅内出血（sICH）发生率为 4.5%。独立结局（mRS 0-2）为 26.2%，不良结局（mRS 5-6）为 49.2%。只有 33.5%符合先前 RCT 的严格入组标准。较低的年龄、基线 NIHSS、卒中前 mRS、较高的 ASPECTS 和成功再通是良好结局的独立预测因素。
结论
在临床实践中接受 ET 治疗的大多数卒中患者不符合先前 RCT 的随机分组标准。真实患者队列的结局比随机试验中高度选择的队列更差，而再通成功率、sICH 和结局预测因素相同。我们的发现支持在比 RCT 更广泛的患者人群中进行 ET，并且可能改善临床实践中 LVO 卒中患者的治疗决策。
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