The registry, an FDA-required post-approval study, known as CAPTURE (Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events) was presented today at the American College of Cardiology's 55th Annual Session in Atlanta. The multi-center study was led by Columbia University Medical Center researchers at NewYork-Presbyterian Hospital/Columbia.
Patients with carotid artery blockage have an increased risk of stroke, even if they experience none of the disease's symptoms, which can include weakness, paralysis, visual problems or speech difficulties. The risk of stroke over five years in asymptomatic patients is about one in eight if carotid artery disease is treated only with medical therapy. The Center for Medicare and Medicaid Services currently does not cover carotid stenting for these asymptomatic patients, so many turn to surgery to clear blocked arteries. However, some patients are ineligible for surgery because of other medical conditions.
In CAPTURE, the researchers collected data on 2,500 patients at increased risk for surgery. They were treated by 240 interventionalists at 188 medical centers across the country. All patients received Guidant's FDA-approved RX ACCULINK Carotid Stent System with RX ACCUNET Embolic Protection System. Neurologists otherwise unaffiliated with the study also evaluated patients immediately before and after stenting, and again 30 days later to judge the outcomes of the procedure.
Among asymptomatic patients, the trial found that the rate of major complications (death, stroke or heart attack) within 30 days of the stenting procedure was 5.7 percent, which is lower than the rate found in other studies of similar patients who undergo surgery.
"The scope of this landmark trial provides us with a clear picture of the patients who benefit the most from carotid artery stenting. We hope these results will expand coverage to asymptomatic patients who are risky candidates for surgery," said William Gray, M.D., principal investigator on the study and associate professor of clinical medicine at Columbia University Medical Center and director of endovascular services at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia and the Cardiovascular Research Foundation.
Preliminary results on 1,600 patients in the CAPTURE trial were presented at the Cardiovascular Research Foundation's Transcatheter Cardiovascular Therapeutics (TCT) meeting in October 2005. The results from the 2500 patients confirm the earlier suggestion that carotid artery stenting is highly beneficial for asymptomatic high-risk patients.
The FDA approved carotid artery stenting for symptomatic patients following the pivotal ARCHeR trial, which enrolled a significantly smaller number of patients at centers with expert experience in carotid artery stenting. The larger CAPTURE trial was designed to determine the safety and efficacy of carotid stenting among a broader group of interventionalists with more variable levels of experience. At 5.7 percent, the CAPTURE trial had an even lower combined rate of death, stroke and heart attack than the ARCHeR trial, which had an 8.3 percent rate. The current study also looked for complications that might have gone undetected in the ARCHeR trial, but did not find any.
The CAPTURE trial found that carotid artery stenting had better outcomes in younger patients. Stroke, death or heart attack occurred in 8.9 percent of patients over the age of 80, compared to 4.8 percent of patients under 80. The lowest percentage of adverse effects - 4.2 percent - were in asymptomatic patients under the age of 80.
It is anticipated that the positive results of this trial will support the re-examination, and eventual expansion, of current CMS reimbursement for this procedure and allow access to this promising technology for a greater number of beneficiaries.
In patients with carotid artery disease, the arteries that supply blood to the brain can develop atherosclerosis, a buildup of fat and cholesterol deposits, decreasing blood flow to the brain and increasing the risk of stroke. Approximately 25 percent of strokes are caused by carotid artery disease. Carotid artery stenting is a minimally invasive procedure that combines balloon angioplasty and a stent implant to unblock and reopen the carotid artery.
Columbia University Medical Center provides international leadership in pre-clinical and clinical research, in medical and health sciences education, and in patient care. The medical center trains future leaders in health care and includes the dedicated work of many physicians, scientists, nurses, dentists, and public health professionals at the College of Physicians & Surgeons, the College of Dental Medicine, the School of Nursing, the Mailman School of Public Health, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Columbia University Medical Center researchers are leading the discovery of novel therapies and advances to address a wide range of health conditions. www.cumc.columbia.edu
NewYork-Presbyterian Hospital is the largest not-for-profit, non-sectarian hospital in the country. It provides state-of-the art inpatient, ambulatory and preventive care in all areas of medicine at five major centers: New York-Presbyterian hospital/Columbia University Medical Center, New York-Presbyterian Hospital/Weill Cornell Medical Center, Children's Hospital of New York-Presbyterian, the Allen Pavilion, and the Westchester Division. It consistently ranks as one of the top hospitals in the country in U.S. News & World Report's guide to "America's Best Hospitals." The New York-Presbyterian Healthcare System – an affiliation of acute-care and community hospitals, long-term care facilities, ambulatory sites, and specialty institutes –serves one in four patients in the New York metropolitan area.
The Cardiovascular Research Foundation is dedicated to research and education in the broad subspecialty of interventional cardiology and endovascular medicine. By establishing the safe use of new technologies and pharmacologic agents, CRF has for more than 15 years played a major role in the remarkable advances in survival and quality of life being realized for patients with cardiovascular disease. By collaborating with talented colleagues from around the world and through the development of innovative educational programs, CRF serves as a major catalyst in the field of interventional vascular medicine.