前瞻性随机临床试验比较颈动脉内膜切除术与 ACUSEAL 聚四氟乙烯修补与心包修补的长期耐久性和临床结果。
Long-term durability and clinical outcome of a prospective randomized trial comparing carotid endarterectomy with ACUSEAL polytetrafluoroethylene patching versus pericardial patching.
机构信息
Department of Surgery, West Virginia University, Charleston, WV.
Department of Surgery, West Virginia University, Charleston, WV.
出版信息
J Vasc Surg. 2023 Jun;77(6):1694-1699.e2. doi: 10.1016/j.jvs.2023.01.189. Epub 2023 Mar 21.
BACKGROUND
Several studies have shown the superiority of carotid endarterectomy (CEA) with patch closure over primary closure. However, no definite study has shown any significant differences in clinical outcome between various types of patches. Because more vascular surgeons have used pericardial patching recently, this study will analyze the late clinical outcome (≥10 years) of our previously reported prospective randomized trial comparing CEA with ACUSEAL (polytetrafluoroethylene) vs pericardial patching.
METHODS
A total of 200 CEAs were randomized (1:1) to either Vascu-Guard pericardial patching or ACUSEAL patching. All patients had immediate duplex ultrasound imaging, which was repeated at 6 months and annually thereafter. Kaplan-Meier analysis was used to estimate rates of freedom from stroke, stroke-free survival, and rates of freedom from ≥50% and ≥80% restenosis.
RESULTS
Overall demographic and clinical characteristics were somewhat similar with a mean follow-up of 80 months (range: 0-149 months). The rates of freedom from stroke were 97, 97, 97, 96, 93 for ACUSEAL vs 99, 98, 97, 97, 92 for pericardial patching (P = .1112) at 1, 2, 3, 5, and 10 years, respectively. Similarly, the rates of freedom from stroke/death were 94, 93, 90, 76, 50 for ACUSEAL vs 99, 96, 91, 78, 47 for pericardial patching (P = .8591). The rates of freedom from ≥50% restenosis were 98, 98, 96, 89, 79 for ACUSEAL vs 87, 83, 83, 81, 71 for pericardial patching (P = .0489). The rates of freedom from ≥80% restenosis were 99, 99, 99, 96, 85 for ACUSEAL vs 96, 96, 96, 93, 93 for pericardial patching (P = .9407). The overall survival rates were 95, 94, 91, 77, 51 for ACUSEAL vs 100, 98, 93, 79, 50 for pericardial patching (P = .9123). Other patch complications (eg, rupture, aneurysmal dilation, infection, etc) were similar.
CONCLUSIONS
Both CEA with ACUSEAL (polytetrafluoroethylene) and pericardial patching are durable and have similar clinical outcomes at 10 years except that ACUSEAL patching has significantly better rates of freedom from ≥50% restenosis.
背景
多项研究表明，颈动脉内膜切除术（CEA）联合补片修补优于直接缝合。然而，目前尚无明确的研究表明各种补片在临床结局方面存在显著差异。由于最近越来越多的血管外科医生使用心包补片，因此本研究将分析我们先前报道的一项前瞻性随机试验的晚期临床结局（≥10 年），该试验比较了 CEA 联合 ACUSEAL（聚四氟乙烯）与心包补片修补的效果。
方法
共 200 例行 CEA 的患者被随机（1:1）分为 Vascu-Guard 心包补片组或 ACUSEAL 补片组。所有患者均在术后即刻行双功能超声检查，并在术后 6 个月和此后每年重复检查。Kaplan-Meier 分析用于评估卒中无复发率、无卒中生存、以及免于≥50%和≥80%再狭窄的比例。
结果
总体人口统计学和临床特征相似，平均随访 80 个月（范围：0-149 个月）。ACUSEAL 组的卒中无复发率分别为 97%、97%、97%、96%和 93%，心包补片组分别为 99%、98%、97%、97%和 92%（P=0.1112），在 1、2、3、5 和 10 年时。同样，ACUSEAL 组的卒中/死亡率无复发率分别为 94%、93%、90%、76%和 50%，心包补片组分别为 99%、96%、91%、78%和 47%（P=0.8591）。免于≥50%再狭窄的比例分别为 98%、98%、96%、89%和 79%，心包补片组分别为 87%、83%、83%、81%和 71%（P=0.0489）。免于≥80%再狭窄的比例分别为 99%、99%、99%、96%和 85%，心包补片组分别为 96%、96%、96%、93%和 93%（P=0.9407）。ACUSEAL 组的总体生存率分别为 95%、94%、91%、77%和 51%，心包补片组分别为 100%、98%、93%、79%和 50%（P=0.9123）。其他补片相关并发症（如破裂、动脉瘤扩张、感染等）相似。
结论
CEA 联合 ACUSEAL（聚四氟乙烯）和心包补片修补均是持久的，10 年时的临床结局相似，但 ACUSEAL 补片修补的免于≥50%再狭窄比例更高。
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