Live Surgical Webcast To Highlight New Era Heart Care: Sirolimus-Coated Stents First Tested at Borgess May Dramatically Change Cardiology Care

NOTE: The LIVE Webcast of the CYPHER Stent will be postponed until final FDA approval, which is expected soon. Please check back for the event date and time. Thank you.

Cardiologists will broadcast a live placement of the soon-to-be-FDA-approved CYPHER™ stent via the Internet at 5:30 p.m. on Tuesday, April 22, 2003 from Borgess Medical Center, Kalamazoo, Mich.

This is the first time the CYPHER™ stent will be broadcast anywhere in the United States.

Like coronary angioplasty, the CYPHER™ Sirolimus-eluting, coated-stent may dramatically change cardiac care. And although different types of chemicals are still being tested, Sirolimus-eluting stents are the favorite choice based on a recent, unanimous Food and Drug Administration (FDA) advisory panel endorsement.

Coronary angioplasty has been a giant step for coronary artery disease treatment for the past 25 years. The minimally invasive procedure uses a balloon to widen narrowed arteries. Since the advent of the stent ? a small, expandable wire mesh tube used to hold the artery open ? restenosis, or renarrowing of the artery, has been its major flaw. With drug-eluting stents, this drawback will be largely removed. The FDA panel backing of a Sirolimus-coated stent offered by Johnson & Johnson (J&J), will make this stent the first drug-eluting stent approved for patients in the United States. The device is already approved for use in Europe.

Tim Fischell, MD, Medical Director of Cardiovascular Research at the Borgess Heart Institute and a cardiologist at the Heart Center for Excellence, co-invented the strong yet highly flexible stent (BX Velocity Stent now owned and marketed by J&J), upon which the drug coating is used. Dr. Fischell will be hosting the live procedure Webcast at 5:30 p.m. on April 22, 2003.

In the SIRIUS clinical trial of more than 1,000 patients, the Sirolimus-coated stent had a renarrowing rate of 3.2 percent inside the stent and 5.7 percent around the edges. The 3.2 percent rate represented a 91 percent reduction in renarrowing compared with patients who received bare-metal stents. The 5.7 percent rate represented a 75 percent reduction. Worldwide, among the first 697 patients treated with the Sirolimus stent and followed for 4-24 months, only four patients (0.36 percent) have required a repeat treatment for a blockage.

Sirolimus is an FDA-approved drug that is usually used to prevent rejection in organ transplants. This anti-immune drug does not harm cells, but reduces both cellular proliferation and inflammation. This "dual action" seems to be very effective in preventing scar tissue from forming after stent placement.

With FDA approval, a new era in heart and vascular care is about to begin.

"The Sirolimus-coated stent will help millions of patients worldwide," said William Campbell, MD, Medical Director of the Borgess Cardiovascular Laboratory and cardiologist at the Heart Center for excellence. "The Sirolimus drug-eluting stent was named the American Heart Association's top advancement for heart care in 2001. Americans are expected to benefit from this improved treatment this year with fewer repeat procedures and complications."

Dr. Campbell will be performing the stent procedure on April 9, with the assistance of Michael Lauer, MD, Associate Director of Cardiovascular Research and Director of the Angiographic Core Laboratory at the Borgess Heart Institute and cardiologist with the Heart Center for Excellence. Dr. Lauer's research lab performed much of the pre-clinical analysis of the CYPHER™? Stent.

Drug-Eluting Stents Will Advance Trend for Even Less Invasive Coronary Artery Disease Treatment.

"We're entering a new era in the treatment of coronary disease," said Dr. Fischell. "The coated stent is also being used with good results in clinical studies for in-stent reblockages in older, non-coated stents," Dr. Fischell said. "This may turn out to be a better, safer method than some of the currently available treatments for in-stent reblockage, like radiation."

Some experts believe the coated-stent, and other minimally invasive techniques, will reduce U.S. coronary artery bypass graft (CABG) surgery cases from about 550,000 cases annually today to about 300,000 cases by 2010.

"Diabetics, who have a higher risk of restenosis, and patients with extremely small arteries could greatly benefit from coated stents," said Dr. Lauer. "The benefits of coated stents will not be limited to heart care, but also vascular treatment throughout the body."

CYPHER™ Stent on FDA Fast Track for Approval

Coated stents will cost about two and one-half times the amount of current bare-steel stents. However, less morbidity and the cost savings produced by reducing restenosis should make the drug-eluting stents a clear-cut choice and cost effective, according to Dr. Campbell.

The Centers for Medicare & Medicaid Services (CMS) apparently agrees with the importance of offering the coated stent to Medicare patients as rapidly as possible. In a unprecedented move, CMS assigned two new diagnosis-related groups, or DRGs, for drug-eluting stents even before this new device has gained FDA approval (expected in early April of 2003).

The Johnson & Johnson Sirolimus drug-eluting stent was approved by the European equivalent of the FDA in April 2002. Approval quickly followed the remarkable results of the randomized study with the Sirolimus-coated BX Velocity balloon-expandable stent (RAVEL study). It involved 238 patients in 15 European and four South American countries. In the double-blind study, none of the 120 patients who received the drug-eluting stents suffered restenosis in the first six months. After one year, none of the patients who had received Sirolimus drug-eluting stent in the RAVEL study experienced restenosis.