Stenting in the carotid artery: initial experience in 110 patients

To evaluate the feasibility, safety, and efficacy of intravascular stents in the treatment of extracranial carotid artery occlusive disease.

According to protocol, stent therapy was offered to symptomatic patients with > or = 70% arteriographically defined carotid stenoses or ulcerative lesions and, after September 1994, to asymptomatic patients with > or = 75% stenoses. From April 1993 to September 1995, 110 nonconsecutive patients (79 males; mean age 72 years, range 45 to 85) consented to participate in the study. The majority (79 [72%]) were asymptomatic. Lesions meeting the treatment criteria were in the proximal common (n = 3); mid common (n = 12); distal common (n = 8); internal (ICA) (n = 92); and external (n = 2) carotid arteries. Seven patients had bilateral ICA stenoses, and 17 patients were treated for postsurgical recurrent disease. The mean lesion length and diameter stenosis for all lesions were 12.4 +/- 9.2 mm and 86.5% +/- 10.6%, respectively. The procedures were performed either via direct percutaneous access to the cervical common carotid artery or through a retrograde femoral artery approach. Standard balloon dilation preceded deployment of balloon-expandable stents in most cases. No postprocedural anticoagulation was used (aspirin only).

In 110 patients (117 arteries) intended for treatment, 109 (99.0%) (116 arteries [99.1%]) were successfully treated with 129 stents (128 Palmaz, 1 Wallstent). One percutaneous procedure failed (0.9%) for technical reasons (stent could not be deployed) and was converted to carotid endarterectomy. Minor complications included 4 cases of spasm (successfully treated with papaverine); 1 flow-limiting dissection (stented); and 6 access-site problems. There were 7 strokes (2 major, 5 reversible) (6.4%) and 5 minor transient events (4.5%) that resolved within 24 hours. Three patients were converted to endarterectomy (2.7%) prior to discharge; 1 stroke patient expired (0.9%), and another patient died of an unrelated cardiac event in hospital. In the 30-day postprocedural period, 2 ICA stents occluded (patients asymptomatic). Clinical success at 30 days (no technical failure, death, endarterectomy, stroke, or occlusion) was 89.1% (98/110). Over a mean 7.6-month follow-up (range 2 to 31), no new neurological symptoms developed. Another stent occlusion at 2 months and one case of flow-limiting intimal hyperplasia at 7 months were detected on routine duplex scanning in asymptomatic patients. Life-table analysis shows an 89% cumulative primary patency rate.

Based on this early experience, carotid stenting appears feasible from a technical standpoint, with good midterm patency. However, the incidence of neurological sequelae is a serious problem. Technical enhancements and a more aggressive antiplatelet regimen may have a positive impact on these events.