Prospective randomized study of carotid endarterectomy with polytetrafluoroethylene versus collagen-impregnated Dacron (Hemashield) patching: perioperative (30-day) results

Abstract

Purpose: Several studies have reported that carotid endarterectomy (CEA) with patch angioplasty has results that are superior to primary closure. Polytetrafluoroethylene (PTFE) patching has been shown to have results comparable with autogenous vein patching; however, it requires a prolonged hemostasis time. Therefore, many surgeons are using collagen-impregnated Dacron patching (Hemashield [HP]). This study is the first prospective randomized trial comparing CEA with PTFE patching versus HP patching.

Methods: Two hundred CEAs were randomized into two groups, 100 PTFE and 100 HP patching. All patients underwent immediate postoperative and 1-month postoperative color duplex ultrasound scanning studies. Demographic and clinical characteristics were similar in both groups, including the mean operative diameter of the internal carotid artery.

Results: The perioperative stroke rates were 0% for PTFE, versus 7% for HP (4 major and 3 minor strokes, P =.02). The combined perioperative stroke and transient ischemic attack rates were 3% for PTFE, versus 12% for HP (P =.047). The operative mortality rate for PTFE was 0%, versus 2% for HP (P =.477). Five perioperative carotid thromboses were noted in patients undergoing HP patching, versus none in patients undergoing PTFE patching (P =.07). After 1 month of follow-up, 2% of patients in the PTFE group had a 50% or more restenosis, versus 12% of patients in the HP group (P =.013). The mean operative time for PTFE patching was 119 minutes, versus 113 minutes for HP patching (P =.081). The mean hemostasis time was significantly higher for PTFE patching than for HP patching, 14.4 versus 3.4 minutes (P <.001).

Conclusion: CEA with HP patching had a higher incidence of perioperative strokes, carotid thrombosis, and 50% or more early restenosis than CEA with PTFE patching. However, the mean hemostasis time was higher for PTFE patching than for HP patching.