The HEART HOSPITAL of New Jersey is one of the first hospitals in the nation to perform balloon angioplasty using a new drug-coated stent. The product was given final approval by the Food and Drug Administration (FDA) on Friday, April 25, 2003, and The HEART HOSPITAL of New Jersey implanted two of the drug-coated stents that same day. The new stent is designed to drastically reduce the rate of restenosis (re-blockage).
"This is a huge breakthrough, a major event for interventional cardiology," says Gary Rogal, M.D., Chief of Cardiology for the Saint Barnabas Health Care System. "Initial studies in less complicated cases show that the medicated stent markedly decreases the chance of restenosis, almost to no chance for re-obstruction. The new product greatly enhances our capability to deliver lasting, effective treatment to our patients."
A coronary stent is a small, expandable metal-mesh tube that opens the artery and helps to restore normal blood flow to the heart. The new stents are coated with an immunosuppressant medication that limits the formation of scar tissue.
A REMARKABLE BREAKTHROUGH
For decades, interventional cardiologists have sought a reliable method to stop the accumulation of scar tissue in the arteries of patients who have undergone angioplasty. Now, a new drug-eluding stent, called the Cordis CYPHER™ Sirolimus-eluding Stent, has received unanimous approval by the FDA. Created by Cordis Corporation, a Johnson & Johnson company, the medicated stent is designed to reduce restenosis and is the first medicated stent to be recommended for FDA approval. The new stent is expected to be double the cost of the traditional stent.
In the United States this year about one million patients will undergo a balloon angioplasty procedure, and about 80 to 85 percent of these patients will receive a stent. Of those who undergo angioplasty, 25 percent will experience re-obstruction. In these patients, says Dr. Rogal, the body’s effort to heal causes a build-up of scar tissue in response to the trauma of the implanted stent. This tissue clogs the stent and causes a recurrence of heart disease symptoms.
The stent received approval for European markets in April 2002 and is currently available in 50 countries. Clinical results in the U.S. of the CYPHER™ Stent indicate a significant reduction of in-stent restenosis. In the clinical trial of 1,058 patients, 533 received a stent with a Sirolimus coating and 525 received an uncoated stent. Eight months after the procedure, patients with the medicated stent showed a 91 percent reduction of in-stent restenosis as compared to the control group.
BRINGING PATIENTS THE LATEST TECHNOLOGY
"Another exciting prospect with medicated stents is their role in preventing restenosis in women," says John Ciccone, M.D., cardiologist with The HEART HOSPITAL. "Smaller arteries clog at a higher rate and women tend to have smaller arteries. Angioplasty has not been as successful for women and it is hoped that the lower recurrence rate for restenosis with the medicated stent will improve their effectiveness for women."
It is the hope of all cardiologists, says HEART HOSPITAL cardiologist Najam Wasty, M.D., that the new stents will reduce the rate of those returning for a second procedure, improving patient care in the long run. If their effectiveness proves to be consistent, medicated stents may even be used as an alternative to surgery in a particular cohort of patients. |
