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小核心梗死灶和近端闭塞性缺血性卒中血管内治疗(ESCAPE)随机对照试验中血栓切除术结果的工作流程及治疗时间分析

Analysis of Workflow and Time to Treatment on Thrombectomy Outcome in the Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE) Randomized, Controlled Trial.

作者信息

Menon Bijoy K, Sajobi Tolulope T, Zhang Yukun, Rempel Jeremy L, Shuaib Ashfaq, Thornton John, Williams David, Roy Daniel, Poppe Alexandre Y, Jovin Tudor G, Sapkota Biggya, Baxter Blaise W, Krings Timo, Silver Frank L, Frei Donald F, Fanale Christopher, Tampieri Donatella, Teitelbaum Jeanne, Lum Cheemun, Dowlatshahi Dar, Eesa Muneer, Lowerison Mark W, Kamal Noreen R, Demchuk Andrew M, Hill Michael D, Goyal Mayank

机构信息

From Department of Clinical Neurosciences and Radiology (B.K.M., T.T.S., M.E., N.R.K., A.M.D, M.D.H., M.G.) andDepartment of Community Health Sciences (B.K.M., Y.Z., A.M.D.,M.D.H., M.G.), Cumming School of Medicine, University of Calgary, Canada; Departments of Radiology (J.L.R.) and Medicine (A.S.), University of Alberta, Edmonton, Canada; Departments of Neuroradiology (J.T.) andGeriatric and Stroke Medicine(D.W.), Beaumont Hospital and the Royal College of Surgeons in Ireland, Dublin; Departments of Radiology (D.R.) and Neurosciences (A.Y.P.), University of Montreal, Canada; Department of Neurology, University of Pittsburgh Medical Center, PA (T.G.J.); Acute Stroke Services, University of Tennessee, Chattanooga (B.S.); Department of Radiology, Erlanger Hospital, University of Tennessee, Chattanooga (B.W.B.); Division of Radiology (T.K.) andDivision of Neurology, Department of Medicine (F.L.S.), Toronto Western Hospital, Canada; Colorado Neurological Institute, Engelwood, CO (D.F.F., C.F.); Montreal Neurological Institute, Canada (D.T., J.T.); Departments of Radiology (C.L.) and Neurology (D.D.), University of Ottawa, Canada; Clinical Research Unit, University of Calgary, Canada (M.W.L.); and Hotchkiss Brain Institute, Calgary, Canada (B.K.M., T.T.S., M.E., A.M.D., M.D.H., M.G.).

出版信息

Circulation. 2016 Jun 7;133(23):2279-86. doi: 10.1161/CIRCULATIONAHA.115.019983. Epub 2016 Apr 13.

Abstract

BACKGROUND

The Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE) trial used innovative imaging and aggressive target time metrics to demonstrate the benefit of endovascular treatment in patients with acute ischemic stroke. We analyze the impact of time on clinical outcome and the effect of patient, hospital, and health system characteristics on workflow within the trial.

METHODS AND RESULTS

Relationship between outcome (modified Rankin Scale) and interval times was modeled by using logistic regression. Association between time intervals (stroke onset to arrival in endovascular-capable hospital, to qualifying computed tomography, to groin puncture, and to reperfusion) and patient, hospital, and health system characteristics were modeled by using negative binomial regression. Every 30-minute increase in computed tomography-to-reperfusion time reduced the probability of achieving a functionally independent outcome (90-day modified Rankin Scale 0-2) by 8.3% (P=0.006). Symptom onset-to-imaging time was not associated with outcome (P>0.05). Onset-to-endovascular hospital arrival time was 42% (34 minutes) longer among patients receiving intravenous alteplase at the referring hospital (drip and ship) versus direct transfer (mothership). Computed tomography-to-groin puncture time was 15% (8 minutes) shorter among patients presenting during work hours versus off hours, 41% (24 minutes) shorter in drip-ship patients versus mothership, and 43% (22 minutes) longer when general anesthesia was administered. The use of a balloon guide catheter during endovascular procedures shortened puncture-to-reperfusion time by 21% (8 minutes).

CONCLUSIONS

Imaging-to-reperfusion time is a significant predictor of outcome in the ESCAPE trial. Inefficiencies in triaging, off-hour presentation, intravenous alteplase administration, use of general anesthesia, and endovascular techniques offer major opportunities for improvement in workflow.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT01778335.

摘要

背景

小核心梗死灶与近端闭塞性缺血性卒中血管内治疗(ESCAPE)试验采用创新成像技术和激进的目标时间指标,以证明血管内治疗对急性缺血性卒中患者的益处。我们分析了时间对临床结局的影响,以及患者、医院和卫生系统特征对试验中工作流程的影响。

方法与结果

采用逻辑回归模型分析结局(改良Rankin量表)与间隔时间之间的关系。采用负二项回归模型分析时间间隔(卒中发作至到达具备血管内治疗能力的医院、至符合条件的计算机断层扫描、至腹股沟穿刺以及至再灌注)与患者、医院和卫生系统特征之间的关联。计算机断层扫描至再灌注时间每增加30分钟,实现功能独立结局(90天改良Rankin量表0 - 2)的概率降低8.3%(P = 0.006)。症状发作至成像时间与结局无关(P>0.05)。在转诊医院接受静脉注射阿替普酶(滴注并转运)的患者与直接转运(母船模式)的患者相比,发作至血管内治疗医院到达时间长42%(34分钟)。工作时间就诊的患者与非工作时间就诊的患者相比,计算机断层扫描至腹股沟穿刺时间短15%(8分钟),滴注并转运患者与母船模式患者相比短41%(24分钟),采用全身麻醉时则长43%(22分钟)。血管内手术期间使用球囊导引导管可使穿刺至再灌注时间缩短21%(8分钟)。

结论

在ESCAPE试验中,成像至再灌注时间是结局的重要预测指标。分诊效率低下、非工作时间就诊、静脉注射阿替普酶的使用、全身麻醉的应用以及血管内技术方面存在的问题为工作流程的改进提供了重大机遇。

临床试验注册

网址:http://www.clinicaltrials.gov。唯一标识符:NCT01778335。

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