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Objective: Indications for intervention for moderate-to-severe (> 50% by NASCET criteria) carotid in-stent re-stenosis (C-ISR) are unclear. We therefore sought to compare stroke/death/myocardial infarction (MI) rates between percutaneous interventions and non-operative management for > 50% C-ISR.
Methods: We performed a single-center retrospective review of consecutive patients presenting with > 50% C-ISR to the Vascular Surgery Service. Demographic, comorbidities, intra-operative and postoperative variables were obtained. The degree of stenosis was verified by review of digital subtraction, or computed tomographic angiograms. The primary outcome was stroke/death/MI after the diagnosis of > 50% C-ISR. χ2, Kruskal-Wallis, and Kaplan-Meier analysis was utilized to quantify outcomes between the patients treated percutaneously versus non-operatively.
Results: Over a ten year period, 75 patients presented with > 50% C-ISRs (N=74 male, 98.7%; N=57 asymptomatic, 76.0%) with a median age of 67.5 years (62.8, 74.6). The initial pathology underlying the original stent was atherosclerosis in 33 (70.2%); radiation-induced in 10 (21.3%) and prior carotid endarterectomy (CEA) in 4 (8.51%) and unknown in 28 (37.3%). Forty-seven patients underwent a percutaneous intervention (30 percutaneous angioplasty (PTA) only, 63.8 %; 17 repeat stent and PTA, 36.2%). Median-follow up for the entire cohort was 59.6 months (19.5, 133.3), and similar between the intervention and non-intervention arms. There were no significant differences between the arms with respect to age (p=0.16), medical co-morbidities (p > 0.05), original stent type (p-0.46), or clopidogrel utilization (p=0.74). At thirty-days, stroke/death/MI, was higher in the intervention arm yet the length of stay was higher in the non-intervention arm (p=0.03). During the follow up period, a median of 1.0 procedure was required to maintain patency. By Kaplan-Meier analysis, there were no statistically significant differences between the intervention and non-intervention arms with respect to stroke/death/MI at last follow-up (p=0.82). One-year Kaplan-Meier-estimated patency was superior in the intervention versus the non-intervention arm (117.9 days + 76.8 versus 77.7 days + 99.1; p=0.02).
Conclusions: For > 50% C-ISR, percutaneous interventions fail to improve long-term stroke/death/MI rates relative to non-intervention, though long-term patency is improved. Future appropriately powered, prospective non-inferiority trials may confirm these findings.