Carotid Artery Stent Placement—Ready for Prime Time?

FEW medical debates have been more controversial than that between carotid stent placement and carotid endarterectomy (CEA). This is understandable considering that CEA, after the published report of the North American Symptomatic Carotid Endarterectomy Trial (NASCET) trial (1), represented the gold standard for managing carotid artery occlusive disease (1,2). The NASCET trial (1) was initiated in 1988 and completed in 1991. Patients with symptomatic internal carotid artery stenosis greater than 70% were randomized to receive either CEA or medical management. The periprocedural stroke and death rate in the trial was 5.6%. A cumulative 2-year stroke rate of 9% in patients who underwent CEA, versus 26% in patients who underwent medical management, was noted. Surgeons who participated in the trial were carefully given credentials based on a perioperative stroke and death rate lower than 6% in their most recent 50 consecutive patients who had undergone CEA. What is less understood in the NASCET trial is the 7.6% incidence of cranial nerve palsy and the significant neck hematoma rate of 5.5% (1). In contrast to the high-risk carotid artery stent placement registries and the high-risk randomized clinical Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) trial, NASCET and the Asymptomatic Carotid Atherosclerosis Study (ACAS) trial were trials involving patients at low risk, without significant comorbidity (3,4). Patients with contralateral occlusion comprised the only high-risk subset within the NASCET trial and, in those patients, a perioperative stroke and death rate of 14% was described (1). In the European Carotid Surgical Trial, a perioperative stroke and death rate of 7.1% and a cranial nerve palsy rate of 6.4% were described (5). Chaturvedi et al (6), in a multicenter study, reported an 11% stroke and death rate after CEA, which was believed to represent an accurate account of “real world” endarterectomy results. During this same period, single institutional centers began reporting their data after carotid stent placement in patients in high-risk subsets (7–11). Most of these patients would not have been eligible for enrollment in either the NASCET or ACAS studies. In our experience, only 9% of 540 patients who underwent stent placement would have been eligible for enrollment in either of the NASCET or the ACAS studies (8). However, the Food and Drug Administration declared that carotid stent placement represented a high-risk procedure that would require institutional review board approval and a Food and Drug Administration–approved Investigational Device Exemption before proceeding. It was not until Medicare approved reimbursement for carotid stent placement performed at an approved trial site that carotid stent placement became an acceptable alternative to CEA in a selected high-risk subset of patients.