CAROTID ARTERY BALLOON ANGIOPLASTY AND STENTING TRIAL
THE CREST STUDY
The purpose of this trial is to compare the immediate and long-term results of the new procedure, carotid angioplasty with stenting, to the standard approach to management of patients with carotid bifurcation disease, carotid endarterectomy in patients with symptomatic carotid artery stenosis.
The study is designed as a multi-institutional prospective randomized trial in which appropriately selected patients are allocated to either standard carotid endarterectomy as the control group versus carotid angioplasty with stent placement as the experimental group.
This study is being sponsored by the National Institutes of Neurologic Disease and Stroke of the National Institutes of Health in Washington, DC.
Principal Investigator: Wesley S. Moore, MD
Co-Principal Investigator for Neurology: Jeffrey Saver, MD
Co-Principal Investigator for Interventional Neuroradiology: Pierre Gobin, MD
OBJECTIVE OF CAROTID ENDARTERECTOMY/INTERVENTION:
The objective of surgical or interventional treatment of carotid bifurcation is to prevent stroke. This is accomplished by removing or isolating an atherosclerotic plaque that is present in a critical location at the origin of the internal carotid artery.
Plaques in this location can produce transient or permanent disabling stroke by releasing particles of plaque or clot into the cerebral circulation and causing damage to the brain. Stroke can also be caused by the progression of the plaque to a total obstruction of the artery, leading to cessation of blood flow through that vessel with extension of blood clot into critical vessels to the brain.
There are approximately 600,000 patients who experience a new stroke in the United States each year. Of these, approximately 200,000 will die, making stroke the third leading cause of death in the United States. Approximately 60% of all strokes are directly related to disease of the carotid bifurcation and, hence, are potentially preventable. At the present time, carotid endarterectomy has been proven to be the single most effective means of preventing stroke from plaques in the carotid bifurcation region. Multiple clinical trials, including the North American Symptomatic Carotid Endarterectomy Trial (NASCET), the Asymptomatic Carotid Atherosclerosis Study (ACAS), and the Veterans Administrations Trials on Symptomatic and Asymptomatic Carotid Artery Disease have proven that carotid endarterectomy in properly selected patients undergoing operation by carefully selected surgeons will significantly reduce the risk of stroke when compared with a control group of patients receiving medical treatment alone.
Recently, there has been an interest in treating lesions of the carotid bifurcation with percutaneous balloon angioplasty and stent placement. This follows a current trend in looking for less invasive means of correcting problems in the vascular system. The experience with this new technique, to date, has been anecdotal. Some reports suggest that carotid angioplasty and stenting is as safe as carotid endarterectomy while other reports suggest that the complication rates as well as rates of recurrence are higher with angioplasty than they are with carotid endarterectomy. Because of the current interest in less invasive procedures as well as some evidence of suggesting that angioplasty may be as safe as surgery, the academic medical community has decided that the time was right to compare these two techniques in a scientifically well designed and carefully controlled study in order to best advise the medical community and their patients of the best, safest, and most durable approach to the management of carotid bifurcation disease.
UCLA is particularly well positioned to participate in this trial. The Division of Vascular Surgery has participated in all of the trials of carotid endarterectomy to date. This provides us with both the technical expertise as well as the study infrastructure to carefully manage our patients and to contribute meaningful information to the study and the scientific community. UCLA Medical Center has a large experience in performing carotid endarterectomy with safety. When considering all indications for carotid endarterectomy, our overall risk of stroke associated with the operation is approximately 0.5%, and the risk of death following surgery is 0.5%. These results are among the safest reported worldwide.
CURRENT STATUS OF THE CREST TRIAL:
1. Carotid angioplasty is currently not approved for Medicare reimbursement by health care financing for any patient being treated outside the trial.
2. The trial has been approved and funded by the National Institutes of Health (National Institute of Neurologic Diseases and Stroke).
3. The committee for center selection is now actively engaged in identifying some 20-40 centers throughout the United States for participation. UCLA has already received approval.
4. We anticipate the beginning of patient entry shortly after January 2000.