Department of Vascular Surgery, University of Florence, Italy.
Department of Vascular Surgery, University of Florence, Italy.
Surgeon. 2022 Apr;20(2):85-93. doi: 10.1016/j.surge.2021.02.001. Epub 2021 Mar 6.
To compare the outcomes of heparin bonded expanded polytetrafluoroethylene (HePTFE) and autologous saphenous vein (ASV) in patients undergoing below-knee (BK) femoro-popliteal bypass for critical limb ischemia (CLI).
Retrospective single-centre matched case-control study.
From 2003 to 2019, 275 consecutive BK bypasses for CLI were performed, 109 with the ASV and 166 with a HePTFE graft. All the baseline characteristics that were reliably measured and were potentially relevant in the decision-making process were included as confounders in a logistic regression model and the factors that were significantly different between the two groups then used to perform a propensity matching analysis. Propensity score-based matching was performed in a 1:1 ratio to compare outcomes. Arterial hypertension, hyperlipemia, the need for tibial anastomosis at the distal level and the run-off status were the covariates included in the matching. Follow-up outcomes were estimated by Kaplan-Meier methods and compared with log rank test.
After propensity matching, 101 HePTFE bypasses were matched with 101 ASV bypasses. The median duration of follow-up was 37 months (range 1-192). The 5-year survival rate was 67.5% (standard error (SE) 0.05) in the HePTFe group and 64.5% (SE 0.06) in the ASV group (p = 0.8, log rank 0.04). Primary patency rates were 38% (SE 0.06) in the HePTFE group and 41% (SE 0.06) in the ASV group (p = 0.7, log rank 0.3). Also assisted primary patency and secondary patency rates did not differ in the two groups. Amputation-free survival was 53% (SE 0.05) in the HePTFE group and 58% (SE 0.06) in the ASF group (p = 0.6, log rank 0.2).
HePTFE provided 5-year similar results to those obtained with use of the ASV in equivalent patients with CLI undergoing below-knee or tibial bypass.
比较肝素结合膨胀聚四氟乙烯（HePTFE）和自体大隐静脉（ASV）在接受膝下（BK）股腘旁路移植术治疗严重肢体缺血（CLI）的患者中的治疗效果。
回顾性单中心匹配病例对照研究。
2003 年至 2019 年，对 275 例 CLI 患者实施 BK 旁路移植术，其中 109 例使用 ASV，166 例使用 HePTFE 移植物。所有可可靠测量且在决策过程中可能具有相关性的基线特征均被纳入逻辑回归模型作为混杂因素，并使用这些混杂因素对两组之间差异有统计学意义的因素进行倾向性匹配分析。然后，采用倾向性评分 1:1 匹配比较结局。包括动脉高血压、高脂血症、远端吻合需要行胫骨吻合术以及流出状态等作为匹配的协变量。采用 Kaplan-Meier 方法估计随访结果，并采用对数秩检验进行比较。
经倾向性匹配后，101 例 HePTFE 旁路移植术与 101 例 ASV 旁路移植术相匹配。中位随访时间为 37 个月（范围 1-192）。HePTFe 组 5 年生存率为 67.5%（标准误差（SE）0.05），ASV 组为 64.5%（SE 0.06）（p=0.8，对数秩检验 0.04）。HePTFE 组的一期通畅率为 38%（SE 0.06），ASV 组为 41%（SE 0.06）（p=0.7，对数秩检验 0.3）。两组的辅助一期通畅率和二期通畅率也无差异。HePTFE 组的保肢无截肢生存率为 53%（SE 0.05），ASV 组为 58%（SE 0.06）（p=0.6，对数秩检验 0.2）。
在接受膝下或胫骨旁路移植术的严重肢体缺血患者中，HePTFE 在 5 年时的结果与使用 ASV 相似。
