Description of Treatment:


Stroke is the most common life-threatening neurological disorder and the leading cause of adult long-term disability in North America and is also the third leading cause of death in the United States after heart disease and cancer. Approximately 25% of ischemic stroke events are related to cervical internal carotid occlusive disease with another 8 to 10% of ischemic strokes being due to intracranial arterial occlusive disease. Approximately 700,000 individuals in the United States experience a stroke each year, leading to about $40 billion dollars in direct and indirect costs. Unmodifiable risk factors for stroke include advanced age; male gender; black, Hispanic, or Asian ethnicity; and positive family history. Modifiable risk factors for stroke include hypertension, smoking and environmental tobacco exposure, diabetes and insulin resistance, asymptomatic carotid stenosis, atrial fibrillation and other cardiac diseases, sickle cell disease, and hyperlipidemia.

The purpose of the carotid angioplasty and stent (CAS) procedure is to compress the atherosclerotic plaque and expand the lumen in the target carotid artery(s), although no direct plaque excision takes place. The recent introduction of embolic protection devices is purported to trap emboli dislodged during the procedure and thus to decrease the likelihood of procedure-related stroke. Studies have been performed that compare CAS with carotid endarterectomy (CEA), the reference standard, with the purpose of establishing the equivalence (or lack of equivalence) of the two technologies. Vertebral and intracranial stenting has also been studied but to a much more limited extent.

Committee Conclusions:


With regard to carotid, vertebral, and intracranial angioplasty and stenting the ICSI Technology Assessment Committee finds the following:

1. Carotid angioplasty and stenting (CAS), especially when using an embolic protection device, is a relatively safe procedure when performed by providers experienced with the technology.
   
2. A number of short-term studies have shown CAS to be generally equivalent to carotid endarterectomy (the reference standard) in safety and efficacy, especially in populations at increased risk for surgery (i.e., SAPPHIRE trial). However, lack of longer-term follow-up does not permit conclusions regarding CAS in terms of long-term (greater than 1 year) efficacy. Results of ongoing randomized trials may provide further clarity in this area. (Conclusion Grade III)
   
3. The evidence is scant concerning the efficacy of vertebral and intracranial angioplasty and stenting. Thus, no conclusions can be drawn about the efficacy of these procedures. In addition, vertebral and intracranial artery angioplasty and stenting is technically difficult and carries a high risk of complications, up to 20% in some studies.