Prospective randomized trial of ACUSEAL (Gore-Tex) vs Finesse (Hemashield) patching during carotid endarterectomy: long-term outcome.

Background: Several studies have reported that carotid endarterectomy with patch angioplasty is superior to primary closure. Conventional polytetrafluoroethylene (Gore-Tex, W. L. Gore & Associates, Flagstaff, Ariz) patching has been shown to have results similar to autogenous saphenous vein patching; however, it requires a longer hemostasis time. This study examined the long-term clinical outcome and incidence of restenosis after carotid endarterectomy using the new ACUSEAL (Gore-Tex) patching vs Hemashield Finesse (Boston Scientific Corp, Natick, Mass) patching.

Methods: The study randomized 200 patients (1:1) undergoing carotid endarterectomy to 100 with ACUSEAL patching and 100 with Hemashield-Finesse patching. All patients underwent immediate and 1-month postoperative duplex ultrasound studies, which were repeated at 6-month intervals. Kaplan-Meier analysis was used to estimate the freedom from stroke, stroke-free survival, and the risk of restenosis for both groups.

Results: The demographic and 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 was 5.1 for the ACUSEAL patching vs 3.7 minutes for Finesse patching (P = .01); however, the mean operative times were similar for both groups (P = .61). The incidence of ipsilateral stroke was 2% for ACUSEAL patching (both early perioperative strokes) vs 3% for Finesse patching (2 early and 1 late stroke) at a mean follow-up of 21 months. The respective cumulative stroke-free rates at 1, 2, and 3 years were 98%, 98%, and 98% for ACUSEAL patching vs 97%, 97%, and 97% for Finesse patching (P = .7). The respective cumulative stroke-free survival rates at 1, 2, and 3 years were 97%, 92%, and 88% for ACUSEAL patching vs 96%, 96%, and 91% for Finesse patching (P = .6). The respective freedom from > or =70% carotid restenosis at 1, 2, and 3 years was 98%, 96%, and 89% for ACUSEAL patching vs 92%, 85%, and 79% for Finesse patching (P = .04).

Conclusions: Carotid endarterectomy with ACUSEAL patching and Finesse patching had similar stroke-free rates and stroke-free survival rates. The mean hemostasis time for the ACUSEAL patch was 1.4 minutes longer than that for the Finesse patch; however, the Finesse patch had higher restenosis rates than the ACUSEAL patch.