April 24, 2003
Drug-Coated Stents Arrive In The Quad Cities April 25 With Promise Of Better Results For Heart Patients
Genesis Medical Center is one of the First in the Area to Receive New Device Which Integrates the Latest in Technology and Pharmacology
Patients suffering from coronary artery disease, or hardening of the arteries, will soon have access to a new generation of technology that promises to reduce trips to the hospital for repeat procedures.
A new generation of metal coils called drug-eluted stents promises to significantly reduce the reblockage of stented arteries. The stents, manufactured by Johnson & Johnson, cleared U.S. Food and Drug Administration approval today. Genesis Medical Center has learned it will receive an initial shipment of the devices tomorrow, with regular shipments beginning the second week of May. Interventional cardiologists expect to use the first stents on patients April 25.
The stent will release a tiny amount of an immunosupressant drug called sirolimus directly into the tissue to inhibit the growth of cells that cause narrowings to reoccur.
"This breakthrough technology promises to improve outcomes for many thousands of heart patients undergoing angioplasty and stent placement as a treatment for their coronary artery disease. These new stents should nearly eliminate the need for repeat procedures. We certainly anticipate that the management of blocked coronary arteries will be simplified, and that both doctors and patients will have confidence in the long-term results of these treatments," says cardiologist Edmund P. Coyne, Jr., M.D., of Cardiovascular Medicine, P.C. and Chair of the Genesis Heart Institute Board of Directors.
Interventional cardiology procedures, such as unclogging the arteries with angioplasty or propping them open with metal coils called stents, are now considered a standard form of treatment. Previously, use of bare-metal stents, the tiny scaffolding devices designed to push back coronary artery plaque and keep vessels open, has had its drawbacks. Research shows that reblockage, or in-stent restenosis, occurs in 10-20 percent of the patients treated with coronary artery stents. It is estimated that patients who receive drug-eluted stents will face less than a five to 10 percent chance of reblockage.
"The drug-eluting stent is a breakthrough in coronary therapy. Not only will patient comfort be enhanced and the need for bypass surgery be reduced, long-term cost savings to our health care system are anticipated. The reduced risk of recurrence following stent placement will allow cardiologists to treat many blockages that are currently not easily treated," says Dr. Coyne.
Each year, some 750,000 patients receive a coronary angioplasty procedure in the U.S. Genesis Medical Center performs more than 2,100 coronary angioplasty procedures each year, placing its catheterization lab among the top tier of large programs in the nation. These new treatment options for coronary artery disease now mean that for every one patient who is treated via open-heart surgery at Genesis Medical Center, six are being treated with less-invasive procedures in the catheterization lab.
In November 2002, the Food and Drug Administration Advisory Board recommended approval for commercial release of the Johnson & Johnson stent. The Cordis CYPHER Sirolimus-eluting stent has already been commercially released in Canada and Europe. Other device manufacturers are expected to bring similar stents to market by late 2003, improving availability. The U.S. Department of Health and Human Services began to provide incremental reimbursement for patients covered by Medicare as of April 1, 2003.
In December of 2001, Genesis Heart Institute cardiologists were the first in the area to offer some patients a solution to the in-stent restenosis problem through the use of radiation seed therapy ¾ a procedure that uses seeds of gamma radiation to kill the scar tissue that has built up inside a previously opened artery.
Genesis Heart Institute cardiologists were also the first in the area to use a previous generation of drug-coated stents to treat heart patients for other problems. In February 2001, cardiologists began implanting heparin-coated coronary stents to reduce the risk of blood clotting. These were the first drug-coated stents to receive FDA approval.
Genesis Heart Institute is a regional network of heart specialists treating patients from more than 12 counties in Iowa and Illinois. The Institute serves as a link between heart specialists and other physicians throughout the region, providing patients new advances in detection, treatment and management of heart disease. For more information about heart disease, visit the Genesis Heart Institute Web site at www.genesisheart.com.
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