FDA approval of drug-coated stents to have major impact on future of cardiovascular care
MGH, BIDMC and BWH conducted local clinical trial

BOSTON - April 24, 2003 - Researchers at three Boston hospitals - Massachusetts General Hospital (MGH), Beth Israel Deaconess Medical Center (BIDMC) and Brigham and Women's Hospital (BWH) - who jointly coordinated and were the only participating New England centers for the national clinical trial of drug-coated stents, hailed today's decision by the Food and Drug Administration (FDA) to approve these devices for widespread use in cardiovascular care.

Currently, metal stents are implanted to prevent blood vessels on the heart from closing after angioplasty, a procedure in which a balloon catheter is inserted to clear blocked arteries. It is estimated that more than 20 percent of angioplasty patients suffer restenosis, a condition in which the arteries do not heal well around the device, and eventually narrow or close off again, necessitating repeat angioplasty or heart bypass surgery.

Today's FDA approval clears the way for the device to be made widely available in the United States. The FDA advisory panel unanimously recommended the device be approved last October after reviewing the study's results.

"The study looked at a wide variety of subsets of patients whom we treat with stents - including both conventional patients as well as those with diabetes, hypertension, long segments of narrowing, and others at severe risk for restenosis," said Igor Palacios, MD, Director, Cardiac Catheterization Laboratory at MGH. "Remarkably, the advantages of using the drug-coated stent were seen across the board, in essentially all types of patients. Since most patients appear to benefit, the implications of this new therapy are profound, now that that this technology will be available for routine use."

The stents that were studied are coated with a drug that arrests cell growth and stops scar tissue from forming within arteries that have been opened. The stents release the drug slowly over the first few weeks after insertion, when scarring is most likely to occur.

"When we tested the drug-coated devices versus the plain metal version on patients, the results were very compelling. In approximately 95 percent of patients receiving the drug-coated stents, restenosis was prevented," said Campbell Rogers, MD, Director, Cardiac Catheterization Laboratory at BWH. "Drug-coated stents will be the new standard of cardiovascular care essentially immediately upon their release."

"With more than one million patients undergoing angioplasty and stenting annually, the patient population that this change will impact immediately is immense," said Joseph Carrozza, MD, Director of Interventional Cardiology at BIDMC. "The stent will dramatically improve the overall quality of care by reducing the likelihood a patient will have to undergo repeated invasive procedures. We anticipate the devices will be widely available within the next several weeks."

The national clinical trial, which was funded by Cordis Corporation, a unit of Johnson & Johnson Company, and the maker of the stent, followed 1,058 patients for eight months. The trial involved MGH, BWH, BIDMC, and 50 other medical facilities around the country. In the study, the clinical outcomes of 533 patients who received the drug-coated stent were compared to 525 patients who were treated with the metal stent.

In addition to their positions at each respective hospital, the three physicians involved in this study are also on the faculty of Harvard Medical School.

MGH, established in 1811, is the original and largest teaching hospital of Harvard Medical Schoo and a founding member of Partners HealthCare System. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $350 million and major research centers in AIDS, cardiovascular research, cancer, cutaneous biology, neurodegenerative disorders, transplantation biology and photomedicine.

BIDMC is a major patient care, research and teaching affiliate of Harvard Medical School and a founding member of CareGroup Healthcare System. Beth Israel Deaconess is the third largest recipient of National Institutes of Health research funding among independent U.S. teaching hospitals.

BWH is a 716-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare System. Internationally recognized as a leading academic health care institution, BWH is committed to excellence in patient care, research, and medical education. A leading recipient of research grants from the National Institutes of Health, BWH conducts internationally acclaimed clinical, basic and epidemiological studies.

Media Contact: Michelle Marcella, MGH Public Affairs

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