Background/purpose: This study analyzes the safety and efficacy of carotid angioplasty/stenting (CAS) with embolic protection devices in high surgical risk (HSR) patients. PATIENT POPULATION/METHODS: This study includes 100 consecutive HSR patients, who were followed prospectively, and had carotid duplex ultrasounds at 1 month and every 6 months thereafter. A Kaplan-Meier lifetable analysis was used to estimate survival rates, rates of freedom from stroke, and freedom from > or =50% in-stent restenosis.
Results: Mean age was 69.6 years. There were 59 men and 41 women. Mean follow-up was 26.1 months (range, 1-50). Indications for CAS were symptomatic > or =50% stenosis in 47% and > or =80% asymptomatic stenosis in 53%. Procedure success rate was 100%. HSR includes 33% with restenosis and cardiac comorbidity, 21% with restenosis and cardiac/medical comorbidities, 13% with restenosis only, and 33% with cardiac/medical comorbidities. The 30-day perioperative stroke rate was 2% with no perioperative deaths or MI. Stroke-free survival rates were 95%, 91%, 83%, 79%, and 73% at 1, 2, 3, and 4 years, respectively. There were no late strokes. Stroke-free rate was 98% at 1, 2, 3, and 4 years, respectively. Freedom from > or =50% in-stent restenosis was 98%, 93%, 90%, and 79% at 1, 2, 3, and 4 years, respectively. Six patients had asymptomatic > or =80% in-stent restenosis; 3 underwent reintervention (percutaneous transluminal angioplasty). The incidence of in-stent restenosis was not statistically significant between patients who had restenosis after carotid endarterectomy and patients with primary stenting (P = .21).
Conclusions: CAS with embolic protection devices in HSR patients is safe and effective.