PTFE 旁路至膝下动脉：是否需要远端静脉套环？一项前瞻性随机多中心研究。

PTFE bypass to below-knee arteries: distal vein collar or not? A prospective randomised multicentre study.

出版信息

Eur J Vasc Endovasc Surg. 2010 Jun;39(6):747-54. doi: 10.1016/j.ejvs.2010.01.016. Epub 2010 Mar 16.

DOI:10.1016/j.ejvs.2010.01.016

PMID:20236841

Abstract

BACKGROUND

Patency and limb salvage after synthetic bypass to the arteries below-knee are inferior to that which can be achieved with autologous vein. Use of a vein collar at the distal anastomosis has been suggested to improve patency and limb salvage, a problem that is analysed in this randomised clinical study.

METHODS

Patients with critical limb ischaemia undergoing polytetrafluoroethylene (PTFE) bypass to below-knee arteries were randomly either assigned a vein collar or not in two groups - bypass to the popliteal artery below-knee (femoro-popliteal below-knee (FemPopBK)) and more distal bypass (femoro-distal bypass (FemDist)). Follow-up was scheduled until amputation, death or at most 5 years, whichever event occurred first.

RESULTS

In the FemPopBK and in the FemDist groups, 115/202 and 72/150 were randomised to have a vein collar, respectively. Information was available for 345 of 352 randomised patients (98%). At 3 years, primary patency was 26% (95% confidence interval (CI) 18-38) with a vein collar and 43 (33-58) without a vein collar for femoro-popliteal bypass and 20 (11-38), and 17 (9-33) for femoro-distal bypass, respectively. The corresponding figures for limb salvage were 64 (54-75) and 61 (50-74) for femoro-popliteal bypass, and 59 (46-76) and 44 (32-61) for femoro-distal bypass with and without a vein collar, respectively. Log-rank-test for the whole Kaplan-Meier life table curve showed no statistically significant differences with or without vein collar primary patency: p = 0.0853, p = 0.228; secondary patency: p = 0.317, p = 0.280; limb salvage: p = 0.757, p = 0.187 for FemPopBK and FemDist, respectively. The use of a vein collar did not influence patency or limb salvage.

CONCLUSION

This study failed to show any benefit for vein collar with PTFE bypass to a below-knee artery.

摘要

背景

人工合成旁路至膝下动脉的通畅率和肢体存活率低于自体静脉。在远端吻合口使用静脉套环可改善通畅率和肢体存活率，本随机临床研究对此问题进行了分析。

方法

患有严重肢体缺血的患者接受聚四氟乙烯（PTFE）至膝下动脉旁路手术，随机分为两组：膝下腘动脉旁路（膝下股腘旁路（FemPopBK））和更远端旁路（膝下股远旁路（FemDist））。随访计划直至截肢、死亡或最长 5 年，以先发生的事件为准。

结果

在 FemPopBK 和 FemDist 组中，分别有 202 例和 150 例患者被随机分配使用静脉套环。352 名随机患者中有 345 名（98%）可获得信息。3 年时，带静脉套环的股腘旁路的初始通畅率为 26%（95%置信区间（CI）18-38），无静脉套环的为 43%（33-58）；带静脉套环的膝下股远旁路的初始通畅率为 20%（11-38），无静脉套环的为 17%（9-33）。相应的肢体存活率为带静脉套环的股腘旁路为 64%（54-75），无静脉套环的为 61%（50-74）；带静脉套环的膝下股远旁路为 59%（46-76），无静脉套环的为 44%（32-61）。整个 Kaplan-Meier 生存表曲线的对数秩检验显示，有无静脉套环的初始通畅率：p=0.0853，p=0.228；次级通畅率：p=0.317，p=0.280；肢体存活率：p=0.757，p=0.187，均无统计学意义。使用静脉套环并不影响通畅率或肢体存活率。