Long-term Durability and Clinical Outcome of Prospective Randomized Trial Comparing Carotid Endarterectomy with ACUSEAL PTFE Patching vs Pericardial Patching.

BACKGROUND/PURPOSE: Several studies have shown the superiority of CEA with patch closure over primary closure. However, no definite study has shown any significant differences in clinical outcome between various types of patches. Since more vascular surgeons are utilizing pericardial patching recently, this study will analyze late clinical outcome (≥10-years) of our previously reported prospective randomized trial comparing CEA with ACUSEAL (PTFE) vs pericardial patching.

PATIENT POPULATION/METHODS: 200 CEAs were randomized (1:1) to either VASCU Guard pericardial patching or ACUSEAL patching. All patients had immediate duplex ultrasound which was repeated at six 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 of 0-149 months). Rates of freedom from stroke were 97, 97, 97, 96, 93 for ACUSEAL vs 99, 98, 97, 97, 92, for pericardial patching (p=0.1112) 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=0.8591). Rates of freedom from ≥50% restenosis were 98, 98, 96, 89, 79, for ACUSEAL vs 87, 83, 83, 81, 71 for pericardial patching (p=0.0489). Rates of freedom from ≥80% restenosis were 99, 99, 99, 96, 85, for ACUSEAL vs 96, 96, 96, 93, 93 for pericardial patching (p=0.9407). The overall survival rates were 95, 94, 91, 77, 51 for ACUSEAL vs 100, 98, 93, 79, 50 for pericardial patching (p=0.9123). Other patch complications (e.g., rupture, aneurysmal dilation, infection, etc.) were similar.

CONCLUSION: Both CEA with ACUSEAL (PTFE) and pericardial patching are durable and have similar clinical outcomes at 10 years except ACUSEAL patching has significantly better rates of freedom from ≥50% restenosis.