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FDA is Expected to Approve New Stent

  • September 22, 2003
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Having endured quadruple heart bypass and a hip replacement in 1993, Richard Rittenhouse speaks from experience when he says he hates hospitals.

Rittenhouse, a 59-year-old diabetic, said he almost died during his first open-heart surgery. Even now, after cardiologists detected another blocked coronary artery, Rittenhouse is adamant about not having his chest cracked again.

But he is eagerly awaiting the advent of a less risky, less invasive option - a "drug-eluting" stent. The device elutes, or slowly releases, a drug that greatly reduces the likelihood that the artery will narrow again.

The medical advance allows more dependable artery repair than the bare stents that have been in use for a decade. Compared with open-heart procedures, it does so with a minimum of pain and recovery time.

The U.S. Food and Drug Administration is expected to approve the first drug-eluting stent for use in the United States, Cordis Corp.''s Cypher stent, this month or next.

"I''m taking it easy and medicating myself and waiting for the day this thing is approved," Rittenhouse said.

Cypher has been proved to dramatically reduce the chance of a cardiac artery reclogging in the critical days, weeks and months following the stent insertion.

Dr. John Lasala, Rittenhouse''s cardiologist, is an associate professor at Washington University and director of interventional cardiology and cardiac catheterization at Barnes-Jewish Hospital. Lasala participated in a large clinical trial of Cypher in 2001 and praises it.

He said from 15 to 20 percent of patients treated with bare stents experience a renarrowing, or restenosis, that requires a repeat angioplasty or other follow-up procedure. In these cases, the standard procedure is to follow the blood vessel reopening with a small internal dose of radiation to retard cell growth.

Bypass surgery using an arterial graft is an option, but it''s one patients dread because it increases pain and extends recovery time.

Only 3 percent of the patients who got Cypher stents in the 2001 study required additional treatment because of renarrowing.

Lasala said vessel renarrowing occurs because the body reacts to the trauma of the angioplasty. It tries to lay down a clot to repair the injury. Inflammatory cells migrate to the site to digest extraneous tissue. Those cells signal cell factories dormant since the first trimester of life that it is time to start cranking out new muscle cells. Those cells and cell byproducts can gum up the artery, sometimes within 24 hours.

The drug-eluting stents allow some healing in the vessel wall but keep the body from going overboard in its response.

Those at highest risk for renarrowing following stent placement - diabetics, people with high blood pressure and those with narrow blood vessels and long areas of plaque - also have considerably better outcomes with drug-eluting stents.

Cardiologists say the stents will transform heart medicine. Lasala expects them to become the standard of care.

The drug-eluting stents look and work much like the predecessor bare-stent technology.

The Cypher stent uses Sirolimus, a drug that prevents rejection in kidney transplant patients. Boston Scientific Corp., the company in line to get the second product approval from the FDA, coats its stents with Taxol, a drug used to treat ovarian and uterine cancers. The Cypher stent, made by the Johnson & Johnson subsidiary Cordis, and the Boston Scientific product are already in use in Europe.

In people who have no apparent added risk for significant renarrowing, cardiologists are at a loss to predict who will reclog following a bare stent procedure. For this reason, Dr. Bryan Trimmer, an interventional cardiologist with Cardiology Diagnostics Ltd. in St. Louis County, thinks all patients could benefit from the drug-eluting device.

Trimmer, who has a list of patients waiting for the Cypher stent, expects patients to demand the new devices.

Lasala said the higher product cost may put a drag on universal use. Cordis has not officially announced its price for Cypher, but hospital administrators expected it to cost about $3,000 to $3,200 per unit, roughly $2,000 more than bare stents.

In many cases, hospitals will not be able to pass on all the additional cost, at least at first. Most hospitals make money on cardiac services, but the higher-priced stents will slice, or eliminate, those margins. In addition, hospitals will lose the income from repeat angioplasties to reopen stents.

Not everybody gets a stent during angioplasty, but the majority of the million U.S. patients who have the procedure each year do, and they get more than one stent.

The Centers for Medicare and Medicaid Services pays a fixed sum for angioplasty and stent insertion regardless of how many stents are used. The Medicare program took the virtually unprecedented step of agreeing to pay more before the technology is in general use.

St. Louis hospitals expect Medicare to pay $1,200 more for procedures using the new technology. But because an average procedure uses 1.5 stents, hospitals will be out at least $2,000 per Medicare-reimbursed procedure.

Barbara Harvath, director of emerging technologies for the Sisters of Mercy Health System, a five state, 19-hospital system based in St. Louis, said the math clearly does not favor hospitals. She thinks the reimbursement will eventually catch up.

Until then, Harvath said Mercy expects to lose millions, because of the higher-cost stents, reduced revenue from repeat angioplasties and fewer open-heart surgeries.

Patti Crimmins Reda, director of patient care for heart services at Barnes-Jewish Hospital, added $6 million to her budget this year to build an inventory of drug-eluting stents. She said Barnes-Jewish, the area''s largest hospital, will not lose money on procedures using the drug-eluting stents, but will run slimmer margins.

Device-maker Cordis released a study Monday at the American College of Cardiology meeting in Chicago demonstrating that while the device costs more upfront, it saves payers almost as much by reducing costs of retreatment and rehospitalization.

"We are introducing a new technology that is not going to significantly increase the cost of health care," said Dr. Brian Firth, Cordis'' vice president for medical affairs and health economics.

The Cordis studies do not address whether the drug-eluting stent will reduce the need for open-heart surgery. Firth said the number of bypass surgeries has dropped in recent years while bare stent procedures have been increasing.

"It''s a question of patient preference," he said. "People prefer less pain to more pain and less time off work to more time off work."

Trimmer says the drug-eluting stents may reduce the need for bypass initially, but those stent patients who don''t change their unhealthy ways may eventually require an open-heart procedure.

"You''ve got to get them off cigarettes, make sure they have their diabetes under control. Unfortunately, knowing patients as I do, people will have risk factors they will not control," he said.

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