- The Washington Times - Friday, April 25, 2003

The U.S. Food and Drug Administration yesterday approved a new drug-emitting stent that reduces by about two-thirds the risk of arteries reclogging after they are cleaned out during angioplasty.
Cardiologists have eagerly awaited creation of a better stent, a metal device that props open cleaned out arteries to promote blood flow. They believe Cypher, made by Johnson & Johnson subsidiary Cordis Corp., will sharply improve heart disease treatment.
"Today's approval represents a significant step forward in the treatment of heart disease," Health and Human Services Secretary Tommy G. Thompson said in a statement. "Patients who receive this device will need fewer repeat operations to unclog arteries, which can make a real difference in the quality of their lives."
Every year approximately 800,000 Americans undergo angioplasty, a procedure in which a balloon is threaded inside clogged coronary arteries to push blockages aside, after which a stent is inserted. Up to 30 percent of patients suffer another blockage within a year, requiring either another angioplasty or a bypass surgery.
The new stent used the drug sirolimus, normally used to prevent organ rejection in kidney transplants, to help prevent plaque from building up. Its $3,000 cost is three times the price of stents available today.
Private insurers are expected to cover the cost. But most stent recipients are older patients covered by the federal Medicare program. Medicare is raising its stent reimbursement, but not enough to cover all the extra cost, hospitals say, especially if patients need more than one stent, as many do.
In one study, 1,058 angioplasty patients were given either the Cypher stent or a plain, uncoated one.
Patients in both groups did equally well immediately after the procedure. But after nine months, only 4 percent of those with the Cypher stent required a repeat procedure, compared with 17 percent of those who got regular stents.
In addition, patients treated with the Cypher stent had a restenosis, or reclogging, rate of 9 percent, compared with 36 percent of patients with the uncoated stent.
The FDA reported that the combined occurrence of repeat angioplasty, bypass surgery, heart attacks and death was 9 percent for patients with Cypher stents and 21 percent for those with traditional stents.
The FDA said it approved the drug-emitting stent for marketing, based on a review of laboratory and animal studies and two clinical studies of safety and effectiveness conducted by Cordis, as well as a review of manufacturing techniques for this new combination product.
Drug-emitting stents "provide more effective care for many patients with heart disease," said Dr. Mark McClellan, FDA commissioner.
"This stent is something better that costs more … so the margin of profit on balloon angioplasties will shrink," said Dr. Howard Herrmann, a professor of medicine at the University of Pennsylvania. He is on the cardiac catheterization and intervention committee of the American College of Cardiology.
Dr. Herrmann said "patients are clamoring" for the new stents, and he believes they will be used in the majority of angioplasties. He believes the first Cypher stents will be available within a week.
Despite the higher initial outlay for the new devices, Dr. Herrmann said money eventually will be saved as a result of curtailed follow-up angioplasties and cardiac surgery.
This story is based in part on wire service reports.



Click to Read More

Click to Hide