Columbia Study Shows Widely Used Artery Clearing Device Does Not Help Patients During Heart Attack

Columbia University Medical Center Researchers Publish JAMA Study Showing That Clearing Fatty Deposits and Blood Clots in Angioplasty Procedures During Heart Attack Fails to Improve Patient Outcomes

NEW YORK, NY, March 1, 2005 - Interventional cardiologists from Columbia University Medical Center have shown that a commonly used procedure to remove fatty debris and blood clots from blocked arteries during a heart attack does not improve patient outcomes.

When performed early in patients with heart attacks, angioplasty saves lives and improves patient well-being. A recently introduced procedure, called distal microcirculatory protection, is commonly and successfully used during angioplasty in vein grafts and stenting in carotid arteries. In the last several years doctors have started to use this procedure during heart attack patients, assuming it would also help in this setting. But the study, published in the March 2 issue of the Journal of the American Medical Association, demonstrated that although the devices were successful in removing debris from the arteries in patients undergoing angioplasty during heart attacks, no benefits to the patient were seen. The size of the heart attack was also the same whether the new device was or was not used.

“This trial has led to a fundamental shift in our understanding of the heart attack process. It is likely that damage to the heart is occurring from several causes, and thus the use of distal protection, though effective in removing blood clots and fat, is simply “too little, too late,” said study lead Gregg W. Stone, M.D., director of research and education for the Center for Interventional Vascular Therapy at Columbia University Medical Center and New York-Presbyterian Hospital, and vice-chairman of the Cardiovascular Research Foundation.

The study, which was conducted in 38 institutions in seven countries, examined 501 patients who were having heart attacks, half of whom received distal protection.

During angioplasty procedures, blood clots and fatty deposits in the arteries can be dislodged and clog arteries further downstream. Distal protection devices use a specialized guidewire and catheter to collect and remove this debris.

The study evaluated the efficacy of distal protection devices using several measures, including evaluating patient ST segments – a portion of the EKG that indicates ongoing heart damage when it is elevated. The study showed that the percentage of patients who had normalization of the ST segment were the same, whether or not distal protection devices were used.

The study also measured the size of the heart attacks by measuring the uptake of a tracer in the heart, and found that there was no difference for patients who received distal protection.

Within six months of the heart attack, patients had a comparable frequency of major adverse cardiac events regardless of whether or not they received the treatment.

According to Dr. Stone, not using distal protection devices will reduce the cost of angioplasties during heart attacks, and could avoid potential complications caused by the devices.

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Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, medical education, and health care. The medical center trains future leaders in health care and includes the dedicated work of many physicians, scientists, nurses, dentists, and other health professionals at the College of Physicians & Surgeons, the School of Dental & Oral Surgery, 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. With a strong history of some of the most important advances and discoveries in health care, its researchers are leading the development of novel therapies and advances to address a wide range of health conditions.

The Cardiovascular Research Foundation in New York City is one of the world’s largest private, not-for-profit medical research foundations dedicated to promoting advances in interventional vascular medicine. Its mission is involvement in every stage of translating ideas into practice in interventional cardiology, from research and education to treatment. Founded in 1991, the Cardiovascular Research Foundation has maintained an international reputation for leadership and innovation in the development of minimally invasive techniques and drug-based treatments of heart and vascular diseases.