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一项荟萃分析比较了用于膝上股腘动脉旁路术的膨体聚四氟乙烯移植物和涤纶移植物。

A meta-analysis to compare Dacron versus polytetrafluroethylene grafts for above-knee femoropopliteal artery bypass.

机构信息

Department of Vascular and Endovascular Surgery, Royal Victoria Hospital, Belfast, United Kingdom.

Division of General Surgery, Mayo Clinic, Phoenix, Ariz.

出版信息

J Vasc Surg. 2014 Aug;60(2):506-15. doi: 10.1016/j.jvs.2014.05.049. Epub 2014 Jun 25.

Abstract

BACKGROUND

Surgical revascularization for lower limb ischemia remains an important component for optimization of quality of life and symptoms in patients with peripheral arterial disease. In the absence of a vein graft, prosthetic alternatives are considered. The objective of this meta-analysis was to establish which prosthetic graft, Dacron or polytetrafluroethylene (PTFE), has the better long-term patency in patients undergoing an above-knee femoropopliteal arterial bypass.

METHODS

This meta-analysis was performed by use of Cochrane and Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. An electronic search of all relevant databases was performed from 1990 to 2013 with the Medical Subject Headings "Dacron," "polytetrafluroethylene," "PTFE," "above knee," "femoropopliteal," and "bypass" combined with the Boolean operator "AND." The inclusion criteria were randomized controlled trials, use of Dacron vs PTFE prosthetic conduits, and completion of an above-knee femoropopliteal arterial bypass involving adult patients older than 18 years presenting with disabling claudication, rest pain or tissue loss, occlusion of the superficial femoral artery, and reconstitution of the above-knee popliteal artery. Whenever studies included above- and below-knee data, only the above-knee arterial bypass data were extracted and analyzed. Graft patency rates were calculated with RevMan 5.1 software provided by the Cochrane Collaboration.

RESULTS

Ninety-one publications were reviewed. After exclusion of duplicate, nonrandomized, and alternative bypass surgery studies, eight randomized controlled trials were identified and included in the meta-analysis. Two of the included trials represented follow-up evaluation of two previous studies, and for the purpose of this analysis, the initial and follow-up studies were subsequently evaluated as one trial. In this meta-analysis, 1192 patients were assessed, including 601 Dacron and 591 PTFE above-knee lower limb arterial bypasses. Primary patency was calculated from all included studies. However, only four studies provided data to evaluate secondary patency. Mean age reported was 66 years. Although all studies described cardiovascular comorbidities and risk factors including myocardial ischemia, diabetes, hypertension, and smoking, exact patient numbers were not consistently provided. Included studies evaluated grafts from 5 to 8 mm. Although primary and secondary patency rates at 12 months were not significantly different (relative risk [RR], 0.78; P = .08, and RR, 0.84; P = .52), 24-, 36-, and 60-month primary patency rates were significantly better with Dacron compared with PTFE grafts (RR, 0.79; P = .003; RR, 0.80; P = .03; RR, 0.85; P = .02). Statistical analysis also supported higher secondary patency rates for Dacron at 24 months (RR, 0.75; P = .02) and 60 months (RR, 0.76-0.77; P = .03-.27). Although primary patency was similar between grafts (28% vs 28%; P = .12), secondary patencies were better with Dacron at 10 years (49% vs 35%; P = .01). Antiplatelet and anticoagulation protocols varied between the trials. There was no difference in amputation, overall morbidity, or mortality rates between the two surgical graft populations.

CONCLUSIONS

Current evidence suggests that Dacron prosthetic grafts are superior to PTFE grafts in above-knee femoropopliteal arterial bypass procedures. Further randomized trials targeting standardization of confounding variables, particularly graft size and best medical therapy, are warranted.

摘要

背景

下肢缺血的外科血运重建仍然是改善外周动脉疾病患者生活质量和症状的重要组成部分。在没有静脉移植物的情况下,考虑使用假体替代品。本荟萃分析的目的是确定在接受膝上股腘动脉旁路术的患者中,哪种假体移植物(Dacron 或聚四氟乙烯(PTFE))具有更好的长期通畅率。

方法

本荟萃分析按照 Cochrane 和系统评价和荟萃分析首选报告项目指南进行。从 1990 年到 2013 年,使用“Dacron”、“polytetrafluroethylene”、“PTFE”、“above knee”、“femoropopliteal”和“bypass”的医学主题词,并结合布尔运算符“AND”,对所有相关数据库进行了电子检索。纳入标准为随机对照试验、使用 Dacron 与 PTFE 假体导管以及完成涉及 18 岁以上成人的膝上股腘动脉旁路术,这些患者表现为严重跛行、静息痛或组织缺失、股浅动脉闭塞以及膝上腘动脉再通。只要研究包括膝上和膝下数据,仅提取和分析膝上动脉旁路数据。使用 Cochrane 协作提供的 RevMan 5.1 软件计算移植物通畅率。

结果

共审查了 91 篇文献。排除重复、非随机和替代旁路手术研究后,确定了 8 项随机对照试验并纳入荟萃分析。其中两项纳入的试验代表了两项先前研究的随访评估,为了本分析的目的,随后将初始和随访研究评估为一项试验。在本荟萃分析中,评估了 1192 名患者,包括 601 例 Dacron 和 591 例 PTFE 膝上下肢动脉旁路术。所有纳入的研究均计算了原发性通畅率。然而,只有四项研究提供了评估继发性通畅率的数据。报告的平均年龄为 66 岁。尽管所有研究都描述了心血管合并症和危险因素,包括心肌缺血、糖尿病、高血压和吸烟,但并未始终提供确切的患者人数。纳入的研究评估了 5 至 8 毫米的移植物。虽然 12 个月时的原发性和继发性通畅率没有显著差异(相对风险[RR],0.78;P=0.08,RR,0.84;P=0.52),但 24 个月、36 个月和 60 个月时的原发性通畅率均显著优于 PTFE 移植物(RR,0.79;P=0.003;RR,0.80;P=0.03;RR,0.85;P=0.02)。统计分析还支持 24 个月(RR,0.75;P=0.02)和 60 个月(RR,0.76-0.77;P=0.03-.27)时 Dacron 的继发性通畅率更高。尽管移植物的原发性通畅率相似(28%比 28%;P=0.12),但 10 年后 Dacron 的继发性通畅率更好(49%比 35%;P=0.01)。抗血小板和抗凝治疗方案在试验之间有所不同。两种手术移植物之间的截肢、总发病率或死亡率没有差异。

结论

目前的证据表明,在膝上股腘动脉旁路术,Dacron 假体移植物优于 PTFE 移植物。需要进一步进行针对标准化混杂变量(特别是移植物大小和最佳药物治疗)的随机试验。

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