Alert for increased long-term follow-up after carotid artery stenting: results of a prospective, randomized, single-center trial of carotid artery stenting vs carotid endarterectomy.

BACKGROUND: Carotid endarterectomy (CEA) has been shown to be effective in stroke prevention for patients with symptomatic or asymptomatic carotid artery stenosis. Although several prospective randomized trials indicate that carotid artery stenting (CAS) is an alternative but not superior treatment modality, there is still a significant lack of long-term data comparing CAS with CEA. This study presents long-term results of a prospective, randomized, single-center trial.

METHODS: Between August 1999 and April 2002, 87 patients with a symptomatic high-grade internal carotid artery stenosis (>70%) were randomized to CAS or CEA. After a median observation time of 66 +/- 14.2 months (CAS) and 64 +/- 12.1 months (CEA), 42 patients in each group were re-evaluated retrospectively by clinical examination and documentation of neurologic events. Duplex ultrasound imaging was performed in 61 patients (32 CAS, 29 CEA), and patients with restenosis >70% were re-evaluated by angiography.

RESULTS: During the observation period, 23 patients (25.2%) died (10 CAS, 13 CEA), and three were lost to follow up. The incidence of strokes was higher after CAS, with four strokes in 42 CAS patients vs none in 42 CEA patients. One transient ischemic attack occurred in each group. A significantly higher rate of restenosis >70% (6 of 32 vs 0 of 29) occurred after CAS compared with CEA. Five of 32 CAS patients (15.6%) presented with high-grade (>70%) restenosis as an indication for secondary intervention or surgical stent removal, and three presented with neurologic symptoms. No CEA patients required reintervention (P < .05 vs CAS). A medium-grade (<70%) restenosis was detected in eight of 32 CAS patients (25%) and in one of 29 CEA patients (3.4%). In five of 32 CAS (15.6%) and three of 29 CEA patients (10.3%), a high-grade stenosis of the contralateral carotid artery was observed and treated during the observation period.

CONCLUSION: The long-term results of this prospective, randomized, single-center study revealed a high incidence of relevant restenosis and neurologic symptoms after CAS. CEA seems to be superior to CAS concerning the development of restenosis and significant prevention of stroke. However, the long-term results of the ongoing multicenter trials have to be awaited for a final conclusion.