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血管内介入治疗与手术治疗破裂颅内动脉瘤的随机对照试验:系统评价。

Endovascular Intervention Versus Surgery in Ruptured Intracranial Aneurysms in Equipoise: A Systematic Review.

机构信息

From the School of Health Sciences, Faculty of Biology Medicine and Health, The University of Manchester, United Kingdom (C.L.C., P.W.).

Department of Neurosurgery, Yee Zen General Hospital, Taoyuan, Taiwan (C.L.C.).

出版信息

Stroke. 2020 Jun;51(6):1703-1711. doi: 10.1161/STROKEAHA.120.028798. Epub 2020 May 13.

DOI:10.1161/STROKEAHA.120.028798
PMID:32397934
Abstract

Background and Purpose- The benefits of endovascular intervention over surgery in the treatment of ruptured aneurysms of anterior circulation remains uncertain. Recently, published studies did not find superiority of endovascular intervention, challenging earlier evidence from a clinical trial. The earlier evidence also had a higher than average proportion of patients in good clinical status, leading to uncertainty about external validity of earlier trials. Methods- We performed a systematic review of studies after 2005 under a protocol published in the International Prospective Register of Systematic Reviews. Primary outcomes were posttreatment rebleeding and adverse events (procedural complications). Secondary outcomes were dependency at 3 to 6 and 12 months, delayed cerebral ischemia, and seizures. Results- Rebleeding was more frequent after endovascular intervention (Peto OR, 2.18 [95% CI, 1.29-3.70]; 3104 participants; 15 studies; I=0%, Grading of Recommendations, Assessment, Development and Evaluation: very low certainty of evidence). Fewer adverse events were reported with the endovascular intervention (RR, 0.71 [95% CI, 0.53-0.95]; 1661 participants; 11 studies; I=14%, Grading of Recommendations, Assessment, Development and Evaluation: low certainty of evidence). Three to six months dependency (RR, 0.82 [95% CI, 0.73-0.93]; 4081 participants; 18 studies; I=15%, Grading of Recommendations, Assessment, Development and Evaluation: low certainty of evidence) and 12-month dependency (RR, 0.76 [95% CI, 0.66-0.86]; 1981 participants; 10 studies; I=0%, Grading of Recommendations, Assessment, Development and Evaluation: low certainty of evidence) were lower after endovascular intervention. Conclusions- This study found consistent results between recent studies and the earlier evidence, in that endovascular intervention results in lower chance of dependency compared with surgery for repair of ruptured anterior circulation aneurysms. A lower proportion of patients in good clinical status in this review supports the application of the earlier evidence. Registration- URL: https://www.crd.york.ac.uk/PROSPERO. Unique identifier: CRD42018090396.

摘要

背景与目的-血管内介入治疗在前循环破裂动脉瘤治疗中的优势仍不确定。最近发表的研究并未发现血管内介入治疗的优越性,这对早期临床试验的证据提出了挑战。早期的证据也有高于平均水平的临床状况良好的患者比例,导致对早期试验的外部有效性存在不确定性。方法-我们根据在国际前瞻性系统评价注册库中发表的方案,对 2005 年后的研究进行了系统评价。主要结局为治疗后再出血和不良事件(手术并发症)。次要结局为 3 至 6 个月和 12 个月的依赖性、迟发性脑缺血和癫痫发作。结果-血管内介入治疗后再出血更常见(Peto OR,2.18 [95%CI,1.29-3.70];3104 例患者;15 项研究;I=0%,推荐评估、制定与评价分级:证据确定性极低)。血管内介入治疗的不良事件发生率较低(RR,0.71 [95%CI,0.53-0.95];1661 例患者;11 项研究;I=14%,推荐评估、制定与评价分级:证据确定性低)。3 至 6 个月依赖性(RR,0.82 [95%CI,0.73-0.93];4081 例患者;18 项研究;I=15%,推荐评估、制定与评价分级:证据确定性低)和 12 个月依赖性(RR,0.76 [95%CI,0.66-0.86];1981 例患者;10 项研究;I=0%,推荐评估、制定与评价分级:证据确定性低)在血管内介入治疗后较低。结论-本研究发现近期研究与早期证据之间的结果一致,即与手术治疗前循环破裂动脉瘤相比,血管内介入治疗的依赖性机会较低。本研究中临床状况良好患者比例较低,支持应用早期证据。注册- URL:https://www.crd.york.ac.uk/PROSPERO. 独特标识符:CRD42018090396。

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