BOSTON -- Cardiologists at Beth Israel Deaconess Medical Center have completed their first use of a newly approved drug-coated stent that is expected to dramatically reduce the likelihood a patient will have to undergo repeated invasive procedures.
BIDMC was one of the sites for a national clinical trial of devices that have received approval from the federal Food and Drug Administration (FDA) for widespread use. 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.
"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 study looked at a wide variety of subsets of patients treated with stents, including both conventional patients as well as those with diabetes, hypertension, long segments of narrowing, and others at severe risk for Restenosis. The study found the drug-coated stent benefited patients 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," said Carrozza.
The stents that were studied are coated with a drug which 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 Carrozza. "Drug-coated stents will be the new standard of cardiovascular care essentially immediately upon their release. In addition, BIDMC has been selected for participation in three new studies evaluating the Cypher drug-eluting stent for indications that were not addressed in the SIRIUS trial."
The national clinical trial named SIRIUS, 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 more than 50 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.
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.