Devine Carol, McCollum Charles
Department of Surgery, Wythenshawe Hospital, Manchester M23 9LT, England.
J Vasc Surg. 2004 Nov;40(5):924-31. doi: 10.1016/j.jvs.2004.08.033.
Dacron was largely abandoned for femoropopliteal bypass 30 years ago, because better patency rates were achieved with saphenous vein. Despite the range of potential prosthetics, polytetrafluoroethylne (PTFE) clearly predominates in current femoropopliteal practice. We compared heparin-bonded Dacron (HBD) with PTFE in a randomized multicenter clinical trial.
Over 28 months, 209 patients (179 above-knee disease, 30 below-knee disease) were randomized to receive HBD (n = 106) or PTFE (n = 103) grafts. Aspirin, 300 mg/d, was started before surgery, and was continued if tolerated.
At follow-up for a minimum of 5 years (mean, 76 months; range, 60-89 months), 37 patients (17.7%) had died with patent grafts and 121 (58%) grafts were occluded. Primary patency rate, measured with Kaplan-Meier survival analysis, was 46% (95% confidence interval [CI], 35%-57%) at year 5 for HBD, compared with 35% for PTFE (CI, 25%-45%; P < .055). Long-term patency was achieved in only 4 of 78 interventions performed in 55 thrombosed grafts. Secondary patency rate for HBD was 47% (CI, 36%-58%), and for PTFE was 36% (CI, 26%-46%). Risk factors for arterial disease did not significantly influence prosthetic patency. Major limb amputation was necessary in 9 patients with HBD grafts and 20 patients with PTFE grafts (P < .025). Two amputations in the HBD group and 8 amputations in the PTFE group were in patients undergoing bypass surgery to treat claudication only. Limb salvage rate was 86% (CI, 77%-95%) and 74% (CI, 64%-84%), respectively.
Significantly better patency rates were achieved with HBD than with PTFE at 3 years (P < .044), but the difference was no longer statistically significant at 5 years (P < .055). The incidence of major limb amputation, however, was significantly greater (P < .025) in the PTFE group compared with the HBD group at both 3 and 5 years of follow-up.
30年前，由于大隐静脉搭桥的通畅率更高，涤纶在股腘动脉搭桥手术中已基本被弃用。尽管有多种潜在的人工血管可供选择，但在当前的股腘动脉手术中，聚四氟乙烯（PTFE）显然占据主导地位。我们在一项随机多中心临床试验中比较了肝素结合涤纶（HBD）和PTFE。
在28个月的时间里，209例患者（179例膝上疾病，30例膝下疾病）被随机分为接受HBD（n = 106）或PTFE（n = 103）人工血管移植组。术前开始服用阿司匹林，300 mg/d，若能耐受则持续服用。
在至少随访5年（平均76个月；范围60 - 89个月）时，37例患者（17.7%）在人工血管通畅的情况下死亡，121例（58%）人工血管闭塞。采用Kaplan-Meier生存分析测得的5年时HBD的一期通畅率为46%（95%置信区间[CI]，35% - 57%），而PTFE为35%（CI，25% - 45%；P <.055）。在55条血栓形成的人工血管上进行的78次干预中，只有4次实现了长期通畅。HBD的二期通畅率为47%（CI，36% - 58%），PTFE为36%（CI，26% - 46%）。动脉疾病的危险因素对人工血管通畅率没有显著影响。接受HBD人工血管移植的9例患者和接受PTFE人工血管移植的20例患者需要进行大肢体截肢（P <.025）。HBD组的2例截肢和PTFE组的8例截肢发生在仅接受搭桥手术治疗间歇性跛行的患者中。肢体挽救率分别为86%（CI，77% - 95%）和74%（CI，64% - 84%）。
3年时HBD的通畅率显著优于PTFE（P <.044），但5年时差异不再具有统计学意义（P <.055）。然而，在随访3年和5年时，PTFE组的大肢体截肢发生率显著高于HBD组（P <.025）。
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