A comparative evaluation of polytetrafluoroethylene, umbilical vein, and saphenous vein bypass grafts for femoral-popliteal above-knee revascularization: A prospective randomized Department of Veterans Affairs cooperative study
A comparative evaluation of polytetrafluoroethylene, umbilical vein, and saphenous vein bypass grafts for femoral-popliteal above-knee revascularization: A prospective randomized Department of Veterans Affairs cooperative study
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DOI：
10.1067/mva.2000.106944
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发表时间：
2000-08-01
影响因子：
4.3
通讯作者：
Lee, KK
中科院分区：
文献类型：
--
作者：
Johnson, WC;Lee, KK
目的：目前，股腘膝上动脉旁路移植术的人工血管选择取决于外科医生的偏好，因为现有的比较评价信息尚不确定。退伍军人事务部（VA）合作研究141旨在确定股腘膝上旁路移植术患者使用不同旁路移植物材料是否能改善通畅性。方法：1983年11月至1988年6月，20个VA医疗中心的752名患者随机接受外部支持聚四氟乙烯（PTFE; N = 265）、人脐静脉（HUV; N = 261）或隐静脉（SV; N = 226）用于膝上股腘动脉旁路移植术。67.5%的患者的旁路移植术指征为保肢。第一年每3个月观察一次患者，此后每6个月观察一次。所有患者在研究期间每天服用阿司匹林（650 mg），术前和术后连续测定多普勒踝臂指数（ABI）。当多普勒衍生的术后ABI保持显著改善（比术前值高0.15个单位以上）并且其他客观信息（如血管造影或手术）与这些观察结果不矛盾时，认为旁路移植术通畅。通畅性失败还包括由于感染或血管变性而被移除的旁路移植物。结果：2年时不同导管类型的累积辅助一期通畅率在统计学上相似（SV，81%; HUV，70%; PTFE，69%）。5年后，膝上SV旁路移植物的通畅率（73%）显著（P ≤ 0.01）优于HUV旁路移植物（53%），HUV旁路移植物的通畅率显著（P ≤ 0.01）优于PTFE旁路移植物（39%）。PTFE导管的保肢效果稍差。旁路移植物血栓形成和主要截肢的数量在第一个30天内是最高的HUV group.Conclusion：这项前瞻性随机研究的总体结果表明，SV应被视为旁路移植物的选择股骨腘膝上重建，当使用假体旁路移植物，HUV也应被视为PTFE的替代选择。（J Vasc Surg 2000;32：268-77.）。
Purpose: Currently, the choice of a vascular prosthesis for a femoral-popliteal above-knee arterial bypass graft is left to the surgeon's preference, because the available information on comparative evaluations is inconclusive. The Department of Veterans Affairs (VA) Cooperative Study 141 was established to identify whether improved patency exists with different bypass graft materials for patients with femoral-popliteal above-knee bypass grafts.Methods: Between lune 1983 and June 1988, 752 patients at 20 VA medical centers were randomized to receive either an externally supported polytetrafluoroethylene (PTFE; N = 265), human umbilical vein (HUV; N = 261), or saphenous vein (SV; N = 226) for an above-knee femoral-popliteal bypass graft. The indication for the bypass grafting operation was limb salvage in 67.5% of the patients. Patients were observed every 3 months for the first year and every 6 months thereafter. All patients were instructed to take aspirin (650 mg) daily for the duration of the study.Doppler-derived ankle-brachial indices (ABIs) were determined preoperatively and serially postoperatively. A bypass graft was considered to be patent when the Doppler-derived postoperative ABI remained significantly improved (more than 0.15 units higher than their preoperative value) and additional objective information, such as angiograms or operations, did not contradict these observations. Patency failure also included bypass grafts that were removed because of an infection or aneurysmal degeneration. Patency rates mere compared by using the Kaplan-Meier life table analysis.Results: The cumulative assisted primary patency rates were statistically similar among the different conduit types at 2 years (SV, 81%; HUV, 70%; PTFE, 69%). After 5 years, above-knee SV bypass grafts had a significantly (P less than or equal to .01) better patency rate (73%) than HUV bypass grafts (53%), which had a significantly (P less than or equal to .01) better patency rate than PTFE bypass grafts (39%). Limb salvage was slightly worse with PTFE conduits. The number of bypass graft thromboses and major amputations within the first 30 days was highest in the HUV group.Conclusion: The overall results of this prospective randomized study suggest that the SV should be considered as the bypass graft of choice for femoral-popliteal above-knee reconstruction and that, when a prosthetic bypass graft is used, an HUV should also be considered as an alternative choice to PTFE. (J Vasc Surg 2000;32:268-77.).