Departments of Cardiovascular Surgery and Anesthesiology, Istituto Clinico Pineta Grande, Castel Volturno (CE), Italy.
J Vasc Surg. 2012 Jul;56(1):96-105. doi: 10.1016/j.jvs.2012.01.004. Epub 2012 May 1.
Patients having undergone femoropopliteal bypass surgery remain at significant risk of graft failure. Although antithrombotic therapy is of paramount importance in these patients, the effect of oral anticoagulation therapy (OAT) on outcomes remains unresolved. We performed a randomized, prospective study to assess the impact of OAT plus clopidogrel vs dual antiplatelet therapy on peripheral vascular and systemic cardiovascular outcomes in patients who had undergone femoropopliteal bypass surgery.
Three hundred forty-one patients who had undergone femoropopliteal surgery were enrolled and randomized: 173 patients received clopidogrel 75 mg/d plus OAT with warfarin (C + OAT), and 168 patients received dual antiplatelet therapy with clopidogrel 75 mg/d plus aspirin 100 mg/d (C + acetylsalicylic acid [ASA]). Study end points were graft patency and the occurrence of severe peripheral arterial ischemia, and the incidence of bleeding episodes.
Follow-up ranged from 4 to 9 years. The graft patency rate and the freedom from severe peripheral arterial ischemia was significantly higher in C + OAT group than in C + ASA group (P = .026 and .044, respectively, Cox-Mantel test). The linearized incidence of minor bleeding complications was significantly higher in C + OAT group than in C + ASA group (2.85% patient-years vs 1.37% patient-years; P = .03). The incidence of major adverse cardiovascular events, including mortality, was found to be similar (P = .34) for both study groups.
In patients who have undergone femoropopliteal vascular surgery, combination therapy with clopidogrel plus warfarin is more effective than dual antiplatelet therapy in increasing graft patency and in reducing severe peripheral ischemia. These improvements are obtained at the expenses of an increase in the rate of minor anticoagulation-related complications.
接受股腘旁路手术后的患者仍然存在显著的移植物失败风险。尽管抗血栓治疗对这些患者至关重要，但口服抗凝治疗（OAT）对结局的影响仍未得到解决。我们进行了一项随机、前瞻性研究，以评估 OAT 加氯吡格雷与双联抗血小板治疗对股腘旁路手术后患者的外周血管和全身心血管结局的影响。
纳入并随机分配了 341 例接受股腘旁路手术的患者：173 例患者接受氯吡格雷 75mg/d 加 OAT 用华法林（C + OAT）治疗，168 例患者接受氯吡格雷 75mg/d 加阿司匹林 100mg/d（C + 乙酰水杨酸[ASA]）的双联抗血小板治疗。研究终点是移植物通畅率和严重外周动脉缺血的发生，以及出血事件的发生率。
随访时间为 4 至 9 年。C + OAT 组的移植物通畅率和免于严重外周动脉缺血的发生率明显高于 C + ASA 组（Cox-Mantel 检验，P =.026 和.044）。C + OAT 组的轻微出血并发症的线性发生率明显高于 C + ASA 组（2.85%患者年比 1.37%患者年；P =.03）。两组的主要不良心血管事件（包括死亡率）发生率相似（P =.34）。
在接受股腘血管旁路手术后的患者中，氯吡格雷联合华法林的联合治疗比双联抗血小板治疗更能增加移植物通畅率和减少严重外周缺血。这些改善是以轻微抗凝相关并发症发生率增加为代价的。
