School of Health and Related Research, University of Sheffield, Sheffield, UK.
Br J Surg. 2013 Aug;100(9):1128-37. doi: 10.1002/bjs.9196.
There are several additional techniques designed to enhance conventional percutaneous transluminal balloon angioplasty (PTA). This systematic review assessed current evidence on the clinical effectiveness of additional techniques for infrainguinal peripheral arterial occlusive disease (PAD).
Relevant electronic databases, including MEDLINE, were searched in May 2011. The population comprised participants with symptomatic PAD undergoing endovascular treatment for disease distal to the inguinal ligament. Interventions were additional techniques compared with conventional PTA. Main outcome measures were restenosis and need for reintervention. Randomized clinical trials (RCTs) of clinical effectiveness were assessed for quality and data were extracted. Where appropriate, meta-analysis was undertaken to produce risk ratios (RRs).
Forty RCTs were selected. Meta-analysis showed a significant benefit in reducing restenosis rates at 6 months for self-expanding stents (RR 0.49) and drug-coated balloons (RR 0.40), and at 12 months for endovascular brachytherapy (RR 0.63). There was also evidence that use of a stent-graft significantly reduced restenosis compared with PTA, as did drug-eluting stents compared with bare-metal stents. Meta-analysis showed that use of drug-coated balloons was associated with significantly lower reintervention rates than PTA alone at 6 months (RR 0.24) and 24 months (RR 0.27) of follow-up. There was also evidence of significantly lower reintervention rates for self-expanding stents at 6 months. Other techniques did not show significant treatment effects for restenosis or reintervention.
The conclusions of this review should be tempered by small sample sizes, lack of clinical outcome measures and differing outcome definitions, making direct comparison across trials difficult. However, self-expanding stents, drug-eluting stents and drug-coated balloons appeared to be the most promising technologies worthy of future study.
有几种额外的技术旨在增强传统的经皮腔内血管成形术(PTA)。本系统评价评估了用于治疗股浅动脉闭塞性疾病(PAD)的额外技术的临床有效性的当前证据。
2011 年 5 月,检索了相关的电子数据库,包括 MEDLINE。研究对象为接受血管内治疗的有症状 PAD 患者,病变位于腹股沟韧带以下。干预措施是将额外的技术与传统的 PTA 进行比较。主要观察指标是再狭窄和需要再次介入治疗。对临床有效性的随机临床试验(RCT)进行质量评估,并提取数据。在适当的情况下,进行荟萃分析以产生风险比(RR)。
选择了 40 项 RCT。荟萃分析显示,在 6 个月时,自膨式支架(RR 0.49)和药物涂层球囊(RR 0.40)显著降低再狭窄率,血管内放射治疗(RR 0.63)在 12 个月时也有证据表明,与 PTA 相比,支架-移植物的使用显著降低了再狭窄率,与裸金属支架相比,药物洗脱支架也是如此。荟萃分析显示,与单独 PTA 相比,药物涂层球囊在 6 个月(RR 0.24)和 24 个月(RR 0.27)的随访中再介入率显著降低。在 6 个月时,自膨式支架的再介入率也较低。其他技术对再狭窄或再介入治疗没有显著的治疗效果。
本综述的结论应受到样本量小、缺乏临床结局指标和不同结局定义的限制,使得在试验之间进行直接比较变得困难。然而,自膨式支架、药物洗脱支架和药物涂层球囊似乎是最有前途的技术,值得进一步研究。