University of Connecticut/Hartford Hospital Evidence-based Practice Center, 06102-5037, USA.
Ann Intern Med. 2011 Feb 15;154(4):243-52. doi: 10.7326/0003-4819-154-4-201102150-00306. Epub 2011 Jan 17.
Acute ischemic strokes are associated with poor outcomes and high health care burden. Evidence exists evaluating the use of neurothrombectomy devices in patients receiving currently recommended treatments that may have limited efficacy.
To describe the state of the evidence supporting use of neurothrombectomy devices in the treatment of acute ischemic stroke.
MEDLINE, SCOPUS, the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and Web of Science were searched, without language restrictions, from their inception through May 2010. The MEDLINE and Cochrane Central Register of Controlled Trials searches were updated through November 2010.
Two independent investigators screened citations for human studies of any design or case series or case reports of patients with an acute ischemic stroke that evaluated a neurothrombectomy device and reported at least 1 clinical effectiveness outcome or harm.
Using standardized protocols, 2 independent investigators extracted information about study characteristics and outcomes, and a third reviewer resolved disagreement.
87 articles met eligibility criteria, including 18 prospective single-group studies, 7 noncomparative retrospective studies, and 62 case series or case reports. Two U.S. Food and Drug Administration (FDA)-cleared devices, the MERCI Retriever (Concentric Medical, Mountain View, California) (40%) and the Penumbra System (Penumbra, Alameda, California) (9%), represented a large portion of the available data. All prospective and retrospective studies provided data on successful recanalization with widely varying rates (43% to 78% with the MERCI Retriever and 83% to 100% with the Penumbra System). Rates of harms, including symptomatic (16 studies; 0% to 10% with the MERCI Retriever and 0% to 11% with the Penumbra System) or asymptomatic (13 studies; 28% to 43% and 1% to 30%, respectively) intracranial hemorrhage and vessel perforation or dissection (11 studies; 0% to 7% and 0% to 5%, respectively), also varied by device. Predictors of harm included older age, history of stroke, and higher baseline stroke severity scores, whereas successful recanalization was the sole predictor of good outcomes.
Most available data are from single-group, noncomparative studies. In addition, the patient population most likely to benefit from these devices is undetermined.
Currently available neurothrombectomy devices offer intriguing treatment options in patients with acute ischemic stroke. Future trials should use a randomized design, with adequate power to show equivalency or noninferiority between competing strategies or devices, and strive to identify populations that are most likely to benefit from use of neurothrombectomy devices.
Agency for Healthcare Research and Quality.
急性缺血性中风与不良预后和高医疗负担有关。现有证据评估了在接受目前推荐治疗的患者中使用神经血栓切除术设备的效果，这些治疗可能疗效有限。
描述支持在急性缺血性中风治疗中使用神经血栓切除术设备的证据状况。
无语言限制地检索了 MEDLINE、SCOPUS、Cochrane 对照试验中心注册库、Cochrane 系统评价数据库和 Web of Science，检索时间从其建立到 2010 年 5 月。对 MEDLINE 和 Cochrane 对照试验中心注册库的检索进行了更新，截止日期为 2010 年 11 月。
两名独立的调查员筛选了人类研究的引文，这些研究设计或病例系列或病例报告中均有急性缺血性中风患者，评估了神经血栓切除术设备，并报告了至少 1 项临床有效性结果或危害。
使用标准化协议，两名独立的调查员提取了有关研究特征和结果的信息，第三名审查员解决了分歧。
87 篇文章符合入选标准，包括 18 项前瞻性单组研究、7 项非对照回顾性研究和 62 项病例系列或病例报告。美国食品和药物管理局（FDA）批准的两种设备，MERCI 取栓器（同心医疗，加利福尼亚州山景城）（40%）和 Penumbra 系统（Penumbra，加利福尼亚州阿拉米达）（9%），占可用数据的很大一部分。所有前瞻性和回顾性研究都提供了不同成功率的再通数据（MERCI 取栓器为 43%至 78%，Penumbra 系统为 83%至 100%）。危害发生率，包括症状性（16 项研究；MERCI 取栓器为 0%至 10%，Penumbra 系统为 0%至 11%）或无症状性（13 项研究；分别为 28%至 43%和 1%至 30%）颅内出血和血管穿孔或夹层（11 项研究；分别为 0%至 7%和 0%至 5%），也因设备而异。危害的预测因素包括年龄较大、有中风史和较高的基线中风严重程度评分，而再通是良好结果的唯一预测因素。
大多数可用数据来自单组、非对照研究。此外，最有可能从这些设备中受益的患者人群尚不确定。
目前可用的神经血栓切除术设备为急性缺血性中风患者提供了引人注目的治疗选择。未来的试验应采用随机设计，具有足够的效力来显示竞争策略或设备之间的等效性或非劣效性，并努力确定最有可能从神经血栓切除术设备中获益的人群。
医疗保健研究和质量局。
