Sarac T P, Huber T S, Back M R, Ozaki C K, Carlton L M, Flynn T C, Seeger J M
Department of Surgery, University of Florida College of Medicine, Gainesville 32610-0286, USA.
J Vasc Surg. 1998 Sep;28(3):446-57. doi: 10.1016/s0741-5214(98)70130-2.
Patients with marginal venous conduit, poor arterial runoff, and prior failed bypass grafts are at high risk for infrainguinal graft occlusion and limb loss. We sought to evaluate the effects of anticoagulation therapy after autogenous vein infrainguinal revascularization on duration of patency, limb salvage rates, and complication rates in this subset of patients.
This randomized prospective trial was performed in a university tertiary care hospital and in a Veterans Affairs Hospital. Fifty-six patients who were at high risk for graft failure were randomized to receive aspirin (24 patients, 27 bypass grafts) or aspirin and warfarin (WAR; 32 patients, 37 bypass grafts). All patients received 325 mg of aspirin each day, and the patients who were randomized to warfarin underwent anticoagulation therapy with heparin immediately after surgery and then were started on warfarin therapy to maintain an international normalized ratio between 2 and 3. Perioperative blood transfusions and complications were compared with the Student t test or with the chi2 test. Graft patency rates, limb salvage rates, and survival rates were compared with the Kaplan-Meier method and the log-rank test.
Sixty-one of the 64 bypass grafts were performed for rest pain or tissue loss, and 3 were performed for short-distance claudication. There were no differences between the groups in ages, indications, bypass graft types, risk classifications (ie, conduit, runoff, or graft failure), or comorbid conditions (except diabetes mellitus). The cumulative 5-year survival rate was similar between the groups. The incidence rate of postoperative hematoma (32% vs 3.7%; P = .004) was greater in the WAR group, but no differences were seen between the WAR group and the aspirin group in the number of packed red blood cells transfused, in the incidence rate of overall nonhemorrhagic wound complications, or in the overall complication rate (62% vs 52%). The immediate postoperative primary graft patency rates (97.3% vs 85.2%) and limb salvage rates (100% vs 88.9%) were higher in the WAR group as compared with the aspirin group. Furthermore, the cumulative 3-year primary, primary assisted, and secondary patency rates were significantly greater in the WAR group versus the aspirin group (74% vs 51%, P = .04; 77% vs 56%, P = .05; 81% vs 56%, P = .02) and cumulative limb salvage rates were higher in the WAR group (81% vs 31%, P = .01).
Perioperative anticoagulation therapy with heparin increases the incidence rate of wound hematomas, but long-term anticoagulation therapy with warfarin improves the patency rate of autogenous vein infrainguinal bypass grafts and the limb salvage rate for patients at high risk for graft failure.
伴有边缘静脉导管、动脉血流不佳以及既往旁路移植失败的患者，发生腹股沟下移植血管闭塞和肢体丧失的风险很高。我们试图评估自体静脉腹股沟下血管重建术后抗凝治疗对这部分患者的通畅持续时间、肢体挽救率和并发症发生率的影响。
这项随机前瞻性试验在一家大学三级护理医院和一家退伍军人事务医院进行。56例移植失败风险高的患者被随机分为接受阿司匹林治疗组（24例患者，27条旁路移植血管）或阿司匹林加华法林治疗组（32例患者，37条旁路移植血管）。所有患者每天服用325毫克阿司匹林，随机分配到华法林组的患者在术后立即接受肝素抗凝治疗，然后开始华法林治疗以维持国际标准化比值在2至3之间。围手术期输血情况和并发症采用Student t检验或卡方检验进行比较。移植血管通畅率、肢体挽救率和生存率采用Kaplan-Meier方法和对数秩检验进行比较。
64条旁路移植血管中有61条是为缓解静息痛或组织缺失而进行的，3条是为短距离间歇性跛行而进行的。两组在年龄、适应证、旁路移植血管类型、风险分类（即导管、血流或移植失败）或合并症（糖尿病除外）方面无差异。两组的累积5年生存率相似。华法林组术后血肿发生率更高（32%对3.7%；P = .004），但在输注红细胞数量、总体非出血性伤口并发症发生率或总体并发症发生率方面（62%对52%），华法林组与阿司匹林组之间未观察到差异。与阿司匹林组相比，华法林组术后即刻原发性移植血管通畅率（97.3%对85.2%）和肢体挽救率（100%对88.9%）更高。此外，华法林组的累积3年原发性、原发性辅助性和继发性通畅率显著高于阿司匹林组（74%对51%，P = .04；77%对56%，P = .05；81%对56%，P = .02），华法林组的累积肢体挽救率更高（81%对31%，P = .01）。
围手术期使用肝素抗凝治疗会增加伤口血肿的发生率，但华法林长期抗凝治疗可提高自体静脉腹股沟下旁路移植血管的通畅率以及移植失败高风险患者的肢体挽救率。
