Lundgren Fredrik
Department of Cardiovascular Surgery, Heart Centre, University Hospital, Linköping, Sweden.
Ann Vasc Surg. 2013 Nov;27(8):1124-33. doi: 10.1016/j.avsg.2013.02.009. Epub 2013 Aug 20.
Patency and limb salvage after synthetic bypass to the arteries below the knee are inferior to that which can be achieved with autologous vein. The use of external support of synthetic polytetrafluoroethylene (PTFE) grafts to the below-knee position has been suggested to improve patency and limb salvage, a problem analyzed in this randomized clinical trial. We examined whether external graft support improves patency and/or limb salvage in patients undergoing reconstruction with synthetic PTFE grafts to the below-knee arteries.
Three hundred thirty-four patients with critical limb ischemia undergoing PTFE bypass to below-knee arteries were randomly assigned to have an ordinary PTFE graft or one with external support. Follow-up was scheduled until amputation, death, or at most 5 years, whichever event occurred first.
Patients in both the femoropopliteal and femorodistal groups were randomized to have an externally supported PTFE graft (101/195 patients in the femoropopliteal group and 72/139 patients in the femorodistal group). Follow-up information was available for 329 of 334 randomized patients (99%). At 1 year postprocedure, primary patency for below-knee bypass was 0.55 (95% confidence interval [CI], 0.47-0.64) with and 0.42 (95% CI, 0.34-0.50) without externally supported PTFE grafts, and secondary patency was 0.58 (95% CI, 0.51-0.67) and 0.47 (95% CI, 0.39-0.56), respectively. The corresponding figures for limb salvage were 0.75 (95% CI, 0.68-0.82) and 0.69 (95% CI, 0.62-0.77), respectively. The log rank test revealed statistically significant differences between patients with or without externally supported grafts for patency (primary patency: χ2=4.2 [degrees of freedom=1; P=0.041]; secondary patency: χ2=4.3 [degrees of freedom=1; P=0.037]) but not for limb salvage (limb salvage: χ2=0.2 [degrees of freedom=1; P=0.657]).
External support to a PTFE graft used for bypass to below-knee arteries improves primary and secondary patency but not limb salvage.
合成材料旁路移植至膝下动脉后的通畅率和肢体挽救率低于自体静脉旁路移植。有人建议使用合成聚四氟乙烯（PTFE）移植物的外部支撑来改善膝下部位的通畅率和肢体挽救率，本随机临床试验对这一问题进行了分析。我们研究了在接受合成PTFE移植物重建膝下动脉的患者中，外部移植物支撑是否能改善通畅率和/或肢体挽救率。
334例接受PTFE旁路移植至膝下动脉的严重肢体缺血患者被随机分配接受普通PTFE移植物或有外部支撑的PTFE移植物。随访计划至截肢、死亡或最长5年，以先发生者为准。
股腘组和股胫组患者均被随机分配接受有外部支撑的PTFE移植物（股腘组101/195例患者，股胫组72/139例患者）。334例随机分组患者中有329例（99%）获得随访信息。术后1年，有外部支撑的PTFE移植物膝下旁路移植的一期通畅率为0.55（95%置信区间[CI]，0.47 - 0.64），无外部支撑的为0.42（95% CI，0.34 - 0.50），二期通畅率分别为0.58（95% CI，0.51 - 0.67）和0.47（95% CI，0.39 - 0.56）。相应的肢体挽救率分别为0.75（95% CI，0.68 - 0.82）和0.69（95% CI，0.62 - 0.77）。对数秩检验显示，有或无外部支撑移植物的患者在通畅率方面有统计学显著差异（一期通畅率：χ2 = 4.2[自由度 = 1；P = 0.041]；二期通畅率：χ2 = 4.3[自由度 = 1；P = 0.037]），但在肢体挽救率方面无差异（肢体挽救率：χ2 = 0.2[自由度 = 1；P = 0.657]）。
用于旁路移植至膝下动脉的PTFE移植物的外部支撑可提高一期和二期通畅率，但不能提高肢体挽救率。
