everal trials have shown that carotid endarterectomy is superior to medical treatment alone for the prevention of stroke in patients with significant carotid artery stenosis. [1][2][3][4][5] The SAPPHIRE trial has established carotid artery stenting (CAS) in high-surgical-risk patients as an effective alternative to carotid endarterectomy. 6 CAS after previous balloon dilation has been shown to be a safe, effective, and durable method of treatment for carotid artery disease. 2 We started carotid artery interventions in 1998 and with the exception of the treatment of in-stent restenosis, every carotid intervention implies elective stent implantation. From an initial strategy of predilation followed by stent implantation, we now perform direct carotid artery stenting (DCAS) for the vast majority of lesions.The present prospective, single-center registry was designed to evaluate the feasibility and safety of DCAS with distal protection devices in consecutive patients who were scheduled for endovascular treatment of significant carotid stenoses. A safety and feasibility evaluation of the aggressive approach in indication to endovascular therapy (and only exceptional indication to carotid endarterectomy) was another aim of our study.Circ J 2007; 71: 1468 -1472 (Received February 27, 2007 revised manuscript received April 28, 2007; accepted June 4, 2007 Background Implantation of a carotid artery stent after predilation is a standard approach in the endovascular treatment of carotid artery stenoses. Stenting without predilation may be an alternative approach in a certain subset of patients. The present prospective, single-center registry was designed to evaluate the feasibility and safety of direct carotid artery stenting (DCAS) in high-risk patients.
Methods and ResultsSymptomatic patients with stenosis >50% and asymptomatic patients with stenosis >70% were eligible for enrolment. Criteria for high-risk patients included: need or history of open heart surgery, history of myocardial infarction, multivessel coronary artery disease, left ventricular dysfunction (ejection fraction ≤40%), severe pulmonary or renal disease, significant contralateral carotid disease, previous endarterectomy, and age ≥80 years. All procedures were performed using a filter protection device. Patients underwent complete clinical examination before and after DCAS and at 30-day follow-up. A total of 83 consecutive patients (45 males, 68±9 years, 33% symptomatic) underwent 100 procedures and 103 stents were deployed successfully. The technical success rate of stenting was 100%. Predilation of carotid stenosis was necessary in 1 (1%) procedure. Carotid-artery stenoses before and after DCAS were 80±9% and 7±9%, respectively. The median fluoroscopic time for DCAS was 7 min. The overall rate of in-hospital major adverse cerebrovascular events (death, stroke, myocardial infarction) was 5% (2 minor strokes, 3 transient attacks). There was 1 (1%) minor stroke within the 30-day follow-up. Conclusion DCAS is feasible and can be performed with an accept...