A comparison of balloon-mounted and self-expanding stents in the carotid arteries: immediate and long-term results of more than 500 patients.

Purpose: To compare the rates of neurological complications and restenosis for balloon-mounted (BM) versus self-expanding (SE) stents deployed in the extracranial carotid arteries.

Methods: Among 513 patients (312 men; mean age 71.3 years, range 27-91) who underwent carotid artery stent placement, 496 received 520 stents. The patients were followed with periodic duplex ultrasound examinations; angiography was performed whenever the duplex scan identified a >50% stenosis or symptoms warranted investigation. Periprocedural data on complications were analyzed on an intention-to-treat basis, while intermediate-term neurological complications were compared in stented patients.

Results: In the periprocedural period, there were 19 (3.7%) transient ischemic attacks, 10 (1.9%) minor strokes, 6 (1.2%) major strokes, and 8 (1.6%) deaths among the 513 patients. Five (1.0%) of the deaths were related to neurological complications (3.9% all stroke/neurological death rate). Among the 496 patients receiving 247 (48%) BM stents and 273 (52%) SE stents in 518 arteries, the all stroke/neurological death rates were 3.6% and 4.0%, respectively (p>0.05). During a mean follow-up of 20.6 months (range to 5.6 years), the 3-year freedom from all fatal and ipsilateral nonfatal strokes excluding the 30-day periprocedural period was 95.0% for BM stents and 95.2% for SE devices. Vessel patency (>50%) at 3 years was 92.0% in the population: 96.3% for BM stents and 83.7% for SE stents (p=0.0422).

Conclusions: The rate of neurological complications following carotid stenting has been relatively low overall, and no differences were found relative to the type of stent deployed. Vessel patency was excellent at 3 years, with slightly better patency in BM stents, but because of their vulnerability to compression, they will not replace SE stents.