Khoury Naim N, Darsaut Tim E, Ghostine Jimmy, Deschaintre Yan, Daneault Nicole, Durocher André, Lanthier Sylvain, Poppe Alexandre Y, Odier Céline, Lebrun Louise-Hélène, Guilbert François, Gentric Jean-Christophe, Batista André, Weill Alain, Roy Daniel, Bracard Serge, Raymond Jean
Centre hospitalier universitaire de Montréal, Notre-Dame hospital, department of radiology, 1560, Sherbrooke east, Pavilion Simard, suite Z12909, H2L 4M1 Montreal, Quebec, Canada.
Department of surgery, division of neurosurgery, university of Alberta hospital, Mackenzie health sciences centre, Edmonton, Alberta, Canada (TED).
J Neuroradiol. 2017 Jun;44(3):198-202. doi: 10.1016/j.neurad.2017.01.126. Epub 2017 Feb 24.
Until recently, the benefits of endovascular treatment in stroke were not proven. Care trials have been designed to simultaneously offer yet-to-be validated interventions and verify treatment outcomes. Our aim was to implement a care trial for patients with acute ischemic stroke.
The study was offered to all patients considered for endovascular management of acute ischemic stroke in one Canadian hospital. Inclusion criteria were broad: onset of symptoms≤5h or at any time in the presence of clinical-imaging mismatch and suspected or demonstrated proximal large vessel occlusion. Exclusion criteria were few: established infarction or hemorrhagic transformation of the target symptomatic territory and poor 3-month prognosis. The primary outcome was mRS≤2 at 3 months. Patients were randomly allocated to standard care or standard care plus endovascular treatment. ClinicalTrials.gov: Identifier NCT02157532.
Seventy-seven patients were recruited in 19 months (March 2013-October 2014) at a single center. Randomized allocation was interrupted when other trials showed the benefits of endovascular therapy. At 3 months, 20 of 40 patients (50.0%; 95% CI: 35%-65%) in the intervention group had reached the primary outcome, compared to 14 of 37 patients (37.8%; 95% CI: 24%-54%) in the control group (P=0.36). Eleven patients in the intervention group died within 3 months compared to 9 patients in the standard care group.
A care trial was implemented to offer verifiable care to acute stroke patients. This approach offers a promising means to manage clinical dilemmas and guide uncertain practices.
直到最近，血管内治疗在中风治疗中的益处仍未得到证实。护理试验旨在同时提供尚未经过验证的干预措施并验证治疗结果。我们的目的是为急性缺血性中风患者开展一项护理试验。
该研究面向一家加拿大医院中所有考虑进行急性缺血性中风血管内治疗的患者。纳入标准较为宽泛：症状发作≤5小时，或在存在临床影像不匹配且怀疑或证实近端大血管闭塞的情况下的任何时间。排除标准较少：目标症状区域已确定梗死或出血性转化，以及3个月预后较差。主要结局是3个月时改良Rankin量表评分≤2分。患者被随机分配至标准护理组或标准护理加血管内治疗组。ClinicalTrials.gov标识符：NCT02157532。
在19个月（2013年3月至2014年10月）期间，单一中心招募了77名患者。当其他试验显示血管内治疗的益处时，随机分配被中断。3个月时，干预组40名患者中有20名（50.0%；95%置信区间：35%-65%）达到主要结局，而对照组37名患者中有14名（37.8%；95%置信区间：24%-54%）达到主要结局（P = 0.36）。干预组有11名患者在3个月内死亡，而标准护理组有9名患者死亡。
开展了一项护理试验，为急性中风患者提供可验证的护理。这种方法为处理临床难题和指导不确定的实践提供了一种有前景的手段。
