Prospective, randomized study of external jugular vein patch versus polytetrafluoroethylene patch during carotid endarterectomy: Perioperative and long-term results
Prospective, randomized study of external jugular vein patch versus polytetrafluoroethylene patch during carotid endarterectomy: Perioperative and long-term results
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DOI：
10.1016/s0741-5214(03)00912-1
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发表时间：
2003-12-01
影响因子：
4.3
通讯作者：
Deriu, GP
中科院分区：
文献类型：
--
作者：
Grego, F;Antonello, M;Deriu, GP
目标。本研究的目的是评估颈动脉内膜切除术中使用颈外静脉（EJV）贴片与聚四氟乙烯（PTFE）贴片的相对风险和优势。主要终点是随访期间任何时间的相关神经并发症发生率（RNCR，致死性或致残性卒中）。次要终点包括无卒中生存、30天和长期死亡率、再发狭窄率（大于或等于50%）、闭塞、贴片感染、动脉瘤形成和其他局部并发症。本研究为单中心前瞻性随机临床试验，分为两个3年阶段：1996年12月至1999年3月入组，1999年3月至2002年3月为随访期。纳入标准包括一条适合补片的颈外静脉，定义为静脉直径大于或等于3mm，术前彩色双工超声扫描未发现侧支血管。患者以1:1的比例随机接受EJV贴片（n = 80， A组）或合成贴片（n = 80， B组）。结果。颈动脉内膜切除术和修补由一名外科医生完成。在30个月时，用Kaplan-Meier方法分析，A组（1例同侧致死性卒中）的rncr无率为98.7%，B组（4例同侧致残性卒中）的rncr无率为94.6%，并保持稳定至60个月。log-rank检验无统计学差异。A组1年无卒中生存率为100%，B组为98.7%，A组（1例同侧轻微卒中）30个月无卒中生存率为98.7%，B组为93.6%，60个月无卒中生存率不变。生命表分析显示，两组在6个月时无明显复发性狭窄（大于或等于50%）的比例为97.5%，A组为93.6%，B组为92.2%，30个月时A组为90.2%，B组为86.7%。log-rank检验无统计学差异。复发性狭窄均未超过70%。随访期间未见动脉瘤形成。我们可以得出结论，由于研究的功率限制，使用EJV或PTFE贴片都可以安全地进行颈动脉内膜切除术。EJV用于颈动脉成形术的优点包括材料成本低，移植物感染风险低，并且保留了隐静脉。
Objectives. The purpose of this study was to evaluate the relative risks and advantages of using external jugular vein (EJV) patch, compared with polytetrafluoroethylene (PTFE) patch, during carotid endarterectomy. The primary end point was the relevant neurologic complication rate (RNCR, fatal or disabling stroke) at any time during follow-up. Secondary end points included stroke-free survival, 30-day and long-term mortality, recurrent stenosis rate (greater than or equal to50%), occlusion, patch infection, aneurysm formation, and other local complications.Methods. The study, a prospective randomized clinical trial carried out at a single center, was divided into two 3-year phases: December 1996 to March 1999, when patients were enrolled, and March 1999 to March 2002, which was the follow-up period. Inclusion criteria included an external jugular vein suitable for patching, defined as vein diameter 3 mm or larger and absence of collateral vessels noted on preoperative color duplex ultrasound scans. Patients were prospectively randomized 1:1 to receive either the EJV (n = 80; group A) or synthetic (n = 80; group B) patch. Results. Carotid endarterectomy and patching was performed by one surgeon. At 30 months the RNCR-free rate, analyzed with the Kaplan-Meier method, was 98.7% for group A (I ipsilateral lethal stroke) and 94.6% for group B (4 ipsilateral disabling strokes), and remained stable to 60 months. No statistical difference was observed with the log-rank test. Stroke-free survival rate was 100% for group A and 98.7% for group B at I year, 98.7% for group A and 93.6% for group B (1 ipsilateral minor stroke) at 30 months, and was unchanged at 60 months. Life table analysis demonstrated freedom from significant recurrent stenosis ( greater than or equal to50%) of 97.5% for both groups at 6 months, 93.6% for group A and 92.2% for group B at 30 months, and 90.2% for group A and 86.7% for group B at 60 months. No statistical difference was observed with the log-rank test. In no patients was recurrent stenosis greater than 70%. No aneurysm formation was noted during follow-up.Conclusions. We can conclude, with the power limitation of the study, that carotid endarterectomy can be safely performed with either the EJV or PTFE patch. Advantages of the EJV for carotid angioplasty include no cost for material, low risk for graft infection, and preservation of the saphenous vein.