Healthcare Professionals

Background and Rationale

Stroke is the third leading cause of death and the leading cause of disability in the United States. Each year about 700,000 people experience stroke, resulting in more than 170,000 deaths. Extracranial carotid artery disease (CAD) is responsible for approximately 30% of these strokes. Carotid artery stenosis may be identified following auscultation of a cervical bruit or after a transient ischemic attack (TIA). For many people, cerebral infarction or carotid inclusion is the initial event that identifies this condition.1

The currently accepted treatment for patients with significant carotid artery stenosis is carotid endarterectomy (CEA). Recently, carotid artery stenting (CAS) has emerged as a less invasive alternative procedure in the management of stenosis in patients considered at high risk for CEA.

Outcomes of the 2004 SAPPHIRE clinical trial published in The New England Journal of Medicine demonstrated the equivalence of CAS to CEA in patients considered at risk for complications due to general anesthesia.2 These results and those of other trials have led to the approval of CAS for high-risk individuals.

However, there is a larger population of patients with significant carotid artery stenosis who are asymptomatic and are not at risk for CEA, yet who may be helped by CAS. The ACT I trial was designed to address this population.

 

References
  1. American Heart Association. Heart Disease and Stroke Statistics—2006 Update. Dallas, Tex: American Heart Association; 2006.
  2. Yadav JS, Wholey MH, Kuntz RE, et al. Protected carotid-artery stenting versus endarterectomy in high-risk patients. N Engl J Med. 2004;351:1493-1501.


Carotid stenting is not currently approved by the FDA for asymptomatic patients who are at standard risk for surgery.
CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.