Tufts Center for Clinical Evidence Synthesis, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA
Center for Evidence-based Medicine, Brown University, Providence, RI
Ann Intern Med. 2013 May 7;158(9):676-685. doi: 10.7326/0003-4819-158-9-201305070-00007.
Adults with asymptomatic carotid artery stenosis are at increased risk for ipsilateral carotid territory ischemic stroke.
To examine comparative evidence on management strategies for asymptomatic carotid stenosis and the incidence of ipsilateral stroke with medical therapy alone.
MEDLINE, Cochrane Central Register of Controlled Trials, U.S. Food and Drug Administration documents, and review of references through 31 December 2012.
Randomized, controlled trials (RCTs) and prospective or retrospective nonrandomized, comparative studies of medical therapy alone, carotid endarterectomy (CEA) plus medical therapy, or carotid artery stenting (CAS) plus medical therapy for adults with asymptomatic carotid stenosis, as well as single-group prospective cohort studies of medical therapy, were reviewed.
Two investigators extracted information on study and population characteristics, results, and risk of bias.
Forty-seven studies in 56 publications were eligible. The RCTs comparing CAS and CEA were clinically heterogeneous; 1 RCT reported more but not statistically significant ipsilateral stroke events (including any periprocedural stroke) in CAS compared with CEA, whereas another RCT, in a population at high surgical risk for CEA, did not. Three RCTs showed that CEA reduced the risk for ipsilateral stroke (including any periprocedural stroke) compared with medical therapy alone, but these results may no longer be applicable to contemporary clinical practice. No RCT compared CAS versus medical therapy alone. The summary incidence of ipsilateral stroke across 26 cohorts receiving medical therapy alone was 1.68% per year.
Studies defined asymptomatic status heterogeneously. Participants in RCTs did not receive best-available medical therapy.
Future RCTs of asymptomatic carotid artery stenosis should explore whether revascularization interventions provide benefit to patients treated by best-available medical therapy.
Agency for Healthcare Research and Quality.
无症状颈动脉狭窄的成年人发生同侧颈动脉区域缺血性卒中的风险增加。
研究单独药物治疗对无症状颈动脉狭窄患者的管理策略及同侧卒中发生率的比较证据。
MEDLINE、Cochrane 对照试验中心注册库、美国食品和药物管理局文件,以及截至 2012 年 12 月 31 日的参考文献综述。
对单独药物治疗、颈动脉内膜切除术(CEA)加药物治疗、颈动脉支架置入术(CAS)加药物治疗的成人无症状颈动脉狭窄的随机对照试验(RCT)和前瞻性或回顾性非随机、比较研究,以及药物治疗的单组前瞻性队列研究进行了综述。
两名调查员提取了研究和人群特征、结果以及偏倚风险的信息。
共有 56 篇文献的 47 项研究符合纳入标准。比较 CAS 和 CEA 的 RCT 存在临床异质性;1 项 RCT 报告 CAS 组同侧卒中事件(包括任何围手术期卒中)更多,但无统计学意义,而另一项 RCT 纳入了 CEA 手术高危人群,但未发现差异。3 项 RCT 显示 CEA 降低了同侧卒中(包括任何围手术期卒中)的风险,与单独药物治疗相比,但这些结果可能不再适用于当代临床实践。没有 RCT 比较过 CAS 与单独药物治疗。26 项单独接受药物治疗的队列的同侧卒中发生率汇总为每年 1.68%。
研究对无症状状态的定义存在异质性。RCT 中的参与者未接受最佳药物治疗。
未来的无症状颈动脉狭窄 RCT 应探讨血管重建干预是否对接受最佳药物治疗的患者有益。
美国医疗保健研究与质量局。