May 2, 2003

Medical milestone changes future of cardiovascular care

Researchers at the MGH, BWH and Beth Israel Deaconess Medical Center (BIDMC), who jointly coordinated and were the only participating New England centers for the national clinical trial of drug-coated stents, hailed a April 22 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 this 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.

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.

"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," says Igor Palacios, MD, (left), director of the MGH Cardiac Catheterization Laboratory. "Remarkably, the advantages of using the drug-coated stent were seen in essentially all types of patients. Since most patients appear to benefit, the implications of this new therapy are profound, now that this technology will be available for routine use."

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 the 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 those of 525 patients who were treated with the metal stent.