Is the rationale for carotid angioplasty and stenting in patients excluded from NASCET/ACAS or eligible for ARCHeR justified?

Abstract

Purpose: To compare outcome after carotid endarterectomy (CEA) in patients who would have been excluded from the North American Symptomatic Carotid Endarterectomy Trial (NASCET) or the Asymptomatic Carotid Atherosclerosis Study (ACAS) or would have been eligible for Acculink for Revascularization of Carotids in High Risk Patients (ARCHeR), a current high-risk stent registry, with outcome in a similar cohort at low risk.

Methods: Records of all CEAs performed at our institution from July 1993 to December 2000 were reviewed. Patients were assigned to groups either eligible or ineligible for NASCET and ACAS or ARCHeR, and criteria were stratified according to whether risk was defined by anatomic or medical problems or whether patients were ineligible according to nonmedical protocol exclusion criteria only.

Results: Preoperative and postoperative data were sufficient to determine risk status according to various study criteria in 857 patients. Stroke or death within 30 days, the primary end point, occurred in 2.1% of patients. Rates were similar in patients excluded from (2.7%) or included in (1.6%) NASCET and ACAS and in patients eligible (3.1%) or ineligible (2.1%) for ARCHeR. Rates did not differ according to whether exclusion or inclusion was based on anatomic risk, medical risk, or protocol exclusion, although trends favored worse outcome in the ARCHeR medical risk subgroup. A higher rate of minor complications was found in the elderly; however, stroke and death rates were similar according to age, gender, repeat procedure, or the presence of contralateral occlusion.

Conclusions: No statistically or clinically significant differences were found in combined 30-day stroke or death rates after CEA in any group defined by previous surgical trials or current ongoing high-risk stent registry. While high-risk groups may exist, the premise that operative risk is higher in patients excluded from NASCET and ACAS or eligible for ARCHeR is not supported.