Prospective Randomized Trial of ACUSEAL (Gore-tex) versus Finesse (Hemashield) Patching During Carotid Endarterectomy: Long-Term Outcome

Background: Several studies have reported that carotid endarterectomy (CEA) with patch angioplasty is superior to primary closure. Conventional polytetrafluoroethylene (PTFE, Gore-tex) patching has been shown to have results similar to autogenous saphenous vein patching, however it requires a longer hemostasis time. This is the first study to examine the long-term clinical outcome and incidence of restenosis after CEA using new ACUSEAL (Gore-Tex) patching versus Hemashield-Finesse patching.
Methods: A total of 200 CEAs were 1:1 randomized into 100 with ACUSEAL patching and 100 with Hemashield-Finesse patching. All patients underwent immediate and one-month postoperative duplex ultrasound studies, which were repeated at six month intervals. A Kaplan-Meier analysis was used to estimate the freedom of stroke, stroke-free survival, and the risk of restenosis for both groups.
Results: The demographic/clinical characteristics, the mean operative diameter of the internal carotid artery, and the length of the arteriotomy were similar in both groups. The mean hemostasis time for the ACUSEAL patching and Finesse patching was 5.1 versus 3.7 minutes (p=0.01), however the mean operative times were similar for both groups (p=0.61). The incidence of ipsilateral stroke was 2% for ACUSEAL patching (both early perioperative strokes) vs. 3% for Finesse patching (two early and one late stroke) at a mean follow-up of 21 months. The combined (early and late) TIA/stroke and ≥70% restenosis rates were 9% for ACUSEAL patching versus 21% for Finesse patching (p=0.029). The cumulative stroke-free and stroke-free survival rates at 1, 2, and 3 years were 98%, 98%, and 98%; and 97%, 92%, and 88% for ACUSEAL patching vs. 97%, 97%, and 97%; and 96%, 96%, and 91% for Finesse patching (p=0.7 and 0.6), respectively. The freedom from ≥70% carotid restenosis at 1, 2, and 3 years was 98%, 96%, and 89% for ACUSEAL patching versus 92%, 85%, and 79% for Finesse patching (p=0.04).
Conclusions: CEA with ACUSEAL patching and Finesse patching had similar stroke and stroke survival rates. The mean hemostasis time for the ACCUSEAL patch was 1.4 minutes longer than that for the Finesse patch, however the Finesse patch had higher restenosis rates than the ACCUSEAL patch.