Rodrigues Filipe Brogueira, Neves Joana Briosa, Caldeira Daniel, Ferro José M, Ferreira Joaquim J, Costa João
Laboratory of Clinical Pharmacology and Therapeutics, Faculty of Medicine, University of Lisbon, Av Prof Egas Moniz 1649-035, Lisbon, Portugal Clinical Pharmacology Unit, Instituto de Medicina Molecular, Lisbon, Portugal Department of Medicine, Hospital de Santa Maria, Centro Hospitalar Lisboa Norte, Portugal
Department of Medicine, Hospital de Santa Maria, Centro Hospitalar Lisboa Norte, Portugal.
BMJ. 2016 Apr 18;353:i1754. doi: 10.1136/bmj.i1754.
To evaluate the efficacy and safety of endovascular treatment, particularly adjunctive intra-arterial mechanical thrombectomy, in patients with ischaemic stroke.
Systematic review and meta-analysis.
Medline, Embase, Cochrane Central Register of Controlled Trials, Web of Science, SciELO, LILACS, and clinical trial registries from inception to December 2015. Reference lists were crosschecked.
Randomised controlled trials in adults aged 18 or more with ischaemic stroke comparing endovascular treatment, including thrombectomy, with medical care alone, including intravenous recombinant tissue plasminogen activator (rt-PA). Trial endpoints were functional outcome (modified Rankin scale scores of ≤2) and mortality at 90 days after onset of symptoms. No language or time restrictions applied.
10 randomised controlled trials (n=2925) were included. In pooled analysis endovascular treatment, including thrombectomy, was associated with a higher proportion of patients experiencing good (modified Rankin scale scores ≤2) and excellent (scores ≤1) outcomes 90 days after stroke, without differences in mortality or rates for symptomatic intracranial haemorrhage, compared with patients randomised to medical care alone, including intravenous rt-PA. Heterogeneity was high among studies. The more recent studies (seven randomised controlled trials, published or presented in 2015) proved better suited to evaluate the effect of adjunctive intra-arterial mechanical thrombectomy on its index disease owing to more accurate patient selection, intravenous rt-PA being administered at a higher rate and earlier, and the use of more efficient thrombectomy devices. In most of these studies, more than 86% of the patients were treated with stent retrievers, and rates of recanalisation were higher (>58%) than previously reported. Subgroup analysis of these seven studies yielded a risk ratio of 1.56 (95% confidence interval 1.38 to 1.75) for good functional outcomes and 0.86 (0.69 to 1.06) for mortality, without heterogeneity among the results of the studies. All trials were open label. Risk of bias was moderate across studies. The full results of two trials are yet to be published.
Moderate to high quality evidence suggests that compared with medical care alone in a selected group of patients endovascular thrombectomy as add-on to intravenous thrombolysis performed within six to eight hours after large vessel ischaemic stroke in the anterior circulation provides beneficial functional outcomes, without increased detrimental effects.
PROSPERO CRD42015019340.
评估血管内治疗,特别是辅助动脉内机械取栓术,对缺血性中风患者的疗效和安全性。
系统评价和荟萃分析。
从创刊至2015年12月的Medline、Embase、Cochrane对照试验中央注册库、科学引文索引、SciELO、LILACS以及临床试验注册库。对参考文献列表进行了交叉核对。
年龄在18岁及以上的缺血性中风成年患者的随机对照试验,比较血管内治疗(包括取栓术)与单纯药物治疗(包括静脉注射重组组织型纤溶酶原激活剂(rt-PA))。试验终点为功能结局(改良Rankin量表评分≤2)和症状出现后90天的死亡率。无语言或时间限制。
纳入10项随机对照试验(n = 2925)。汇总分析显示,与单纯接受包括静脉rt-PA在内的药物治疗的患者相比,血管内治疗(包括取栓术)使中风后90天功能良好(改良Rankin量表评分≤2)和极好(评分≤1)结局的患者比例更高,在死亡率或症状性颅内出血发生率方面无差异。研究间异质性较高。较新的研究(2015年发表或公布的7项随机对照试验)因患者选择更准确、静脉rt-PA给药率更高且更早、使用更高效的取栓装置,更适合评估辅助动脉内机械取栓术对其主要疾病的影响。在这些研究中的大多数,超过86%的患者接受了支架取栓器治疗,再通率高于先前报道(>58%)。对这7项研究的亚组分析得出,功能良好结局的风险比为1.56(95%置信区间1.38至1.75),死亡率的风险比为0.86(0.69至1.06),研究结果间无异质性。所有试验均为开放标签。各研究的偏倚风险为中度。两项试验的完整结果尚未发表。
中到高质量的证据表明,在一组选定的患者中,与单纯药物治疗相比,在前循环大血管缺血性中风后6至8小时内进行的静脉溶栓基础上加用血管内取栓术可带来有益的功能结局,且不会增加有害影响。
PROSPERO CRD42015019340