1Department of Medicine, Maimonides Medical Center, Brooklyn, NY 2Department of Medicine, Division of Cardiology, University of Connecticut School of Medicine, Farmington, CT.
Am J Ther. 2013 Sep-Oct;20(5):520-3. doi: 10.1097/MJT.0b013e31822831d8.
Subclavian artery stenosis has long been treated with great success with bypass surgery. Percutaneous intervention, often used in combination with stent placement, has come into vogue for the past few years as a safe and effective therapeutic modality. This study aimed to compare angioplasty alone with angioplasty followed by stent placement by combining available data. The objective of this study was to perform a review of the available literature to compare the efficacy of percutaneous transluminal angioplasty (PTA) alone with PTA followed by stent placement for proximal subclavian artery stenosis. Successful recanalization was defined as patency at the end of 1 year, and reocclusions and restenoses were noted as events for the purpose of pooling the data. The authors searched the Specialized Register and the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, PubMed, EMBASE, and CINAHL databases for relevant trials/studies comparing PTA and PTA with stenting. Review authors independently assessed the methodological quality of studies (focusing on the adequacy of the randomization process, allocation concealment, blinding, completeness of follow-up, and intention-to-treat analysis) and selected studies for inclusion. All retrospective observational studies were also included in the analysis in the absence of double-blinded randomized trials for increasing sample size. All analyses were done using RevMan 5.0. Odds ratio was calculated using Mantel-Haenszel test with a fixed effect model. All included studies were assessed by all authors for potential sources of bias. Eight studies were included in the analysis having 544 participants. Stenting after PTA was significantly superior to angioplasty alone for treatment of subclavian artery stenosis and maintenance of patency at 1 year, as indicated by absence of events (P = 0.004; 95% confidence interval, odds ratio 2.37 [1.32-4.26]) without significant complication rates for either procedure. There is evidence in favor of stent placement after angioplasty for successful recanalization of stenosed subclavian arteries and long-term maintenance of patency without significant increase in risk for major complications in subjects.
锁骨下动脉狭窄一直以来都采用旁路手术来进行有效治疗。近年来,经皮介入治疗,常与支架置入术联合使用,作为一种安全有效的治疗方式逐渐流行起来。本研究旨在结合现有数据,比较单纯血管成形术与血管成形术后支架置入术的疗效。本研究的目的是对现有文献进行综述,比较单纯经皮腔内血管成形术(PTA)与 PTA 后支架置入治疗锁骨下动脉近段狭窄的疗效。成功再通定义为 1 年后血管通畅,再闭塞和再狭窄则被记录为事件,以便对数据进行汇总。作者检索了特殊注册库和 Cochrane 图书馆的 Cochrane 中心对照试验注册库(CENTRAL)、PubMed、EMBASE 和 CINAHL 数据库中比较 PTA 和 PTA 联合支架置入的相关试验/研究。审查作者独立评估了研究的方法学质量(重点关注随机过程的充分性、分配隐匿、盲法、随访完整性和意向治疗分析),并选择了纳入的研究。由于缺乏双盲随机试验来增加样本量,所有回顾性观察性研究也纳入了分析。使用固定效应模型的 Mantel-Haenszel 检验计算比值比。所有纳入的研究都由所有作者评估潜在的偏倚来源。共有 8 项研究纳入分析,共 544 名参与者。血管成形术后支架置入术在治疗锁骨下动脉狭窄和维持 1 年通畅方面明显优于单纯血管成形术,无事件发生(P = 0.004;95%置信区间,比值比 2.37 [1.32-4.26]),两种方法的并发症发生率均无显著差异。有证据支持血管成形术后支架置入术可成功治疗狭窄的锁骨下动脉,并可长期保持通畅,且不会显著增加患者发生主要并发症的风险。