By Tim Bonfield
The Cincinnati Enquirer
It could be a billion-dollar question: Can heart disease patients avoid the need for drug-coated stents that cost thousands of dollars by taking pills that cost hundreds of dollars?
The future of one of the hottest new technologies in cardiac care could be deeply influenced by a clinical trial under way in Cincinnati, Washington, D.C., and a dozen other cities.
The study, led by Dr. Ron Waksman of the Washington Hospital Center, calls for enrolling up to 250 patients in 15 medical centers to compare ways to prevent restenosis - a reclogging that often occurs after doctors place stents to prop open blocked coronary arteries.
The study will test whether a pill form of sirolimus, an anti-rejection drug used by kidney transplant patients, can be as effective at preventing restenosis as putting the same medication on the stent itself.
A drug-eluting stent is coated with a time-released drug that is designed to prevent scar tissue from building up and reclogging an artery propped open by the stent.
So far, six patients have been enrolled in Cincinnati. Results are expected next year, after participants get angiograms conducted six months after treatment.
"It seems regressive to go back to giving something orally instead of using the more recent drug-eluting stents. But for multiple reasons, if this is demonstrated to be effective it may have significant advantages," said Dr. Dean Kereiakes, medical director of the Lindner Center for Cardiovascular Research and one of the nation's leading researchers of stent-technology.
There is little question that drug-eluting stents are better at preventing complications than "bare-metal" stents, Kereiakes said.
Drug-eluting stents have cut the risk of restenosis from a range of 21 percent to 36 percent a few years ago, down to a range of zero to 9 percent, according to several studies.
But this study's outcome could have a powerful effect on the entire field of cardiac care, and could affect the fiscal health of many hospitals. That's because the pill form of the drug costs about $800 for a month-long course. The stent coated with a month-long dose of the drug costs $3,195.
Huge cost concerns
The Cypher stent, made by Cordis Corp., a unit of Johnson & Johnson, became the nation's first FDA-approved drug-eluting stent on April 24.
By April 28, Christ Hospital announced it was offering the new stent. In fact, some patients had been getting the stent since 2001 as part of clinical trials through the Lindner Center.
WHAT IS A STENT?
Stents are tiny, expandable metal mesh tubes that can be used to prop open a clogged blood vessel in the heart, and increasingly, in other places in the body. Hundreds of thousands of Americans get them each year.
Rather than conducting open-chest surgery to clear the blockage or conduct a bypass operation, stents are placed from the inside with significantly less trauma to the patient.
In general, doctors make a hole near the groin to thread a catheter up through a major artery to the heart. The stent is wrapped around a deflated balloon. Upon reaching the clogged part of the artery, the doctor inflates the balloon to expand the stent into its locked, open position.
In a highly competitive race among several manufacturers, many improved stent designs have emerged in recent years. The devices continue getting smaller and more flexible, allowing them to reach clogs in tougher locations.
New drug-eluting stents appear to reduce the biggest problem with stents - that significant numbers of patients suffer restenosis, a reclogging of the artery caused by scar tissue growth in reaction to the device.
Several other Tristate hospitals also offer or plan to offer the product. And other companies are racing to develop stents using other medications.
The Cypher stent is coated with sirolimus, which is made by Wyeth Pharmaceuticals under the brand name Rapamune. Sirolimus is used among organ transplant patients as an anti-rejection medication
The problem: a single Cypher stent sells for $3,195 compared with about $900 for a bare-metal stent. And many patients need two. Some get three or four.
For a patient who needs two Cypher stents, the cost of the devices alone would be nearly $6,400. That compares with about $2,600 for two bare-metal stents and a month of oral sirolimus.
Effective April 1, Medicare has started paying hospitals about $11,800 to place a drug-eluting stent with no heart attack involved - up about $2,100 from the rate for a non-coated stent.
The problem: the rate doesn't cover costs when a single procedure involves placing multiple stents. Hospitals place an average of 1.5 to 1.8 stents per patient.
The government expects nonprofit hospitals to eat the difference, Kereiakes said.
Completely switching over to drug-eluting stents would cost Christ Hospital about $7 million a year, officials have estimated. About 2,300 patients had stents inserted last year at the hospital. Nationwide, the costs could reach billions.
Debate among doctors
Some doctors have argued that the benefits of drug-coated stents are so impressive that they should become standard care.
Even in the simplest cases, drug-eluting stents reduced restenosis. And among higher-risk patients, such as diabetics, the benefits are even more dramatic, said Dr. Patrick Serruys, a cardiac expert from the Netherlands, during a debate last year at the annual meeting of the American Heart Association.
Reduced restenosis means fewer people will die from reclogged arteries; and will instead lead more productive lives. Fewer patients will need expensive follow-up care, be it radiation treatment to fight scarring or open-chest bypass operations.
Such factors could more than offset the increased cost of the drug-eluting stent, Serruys argued.
But Waksman says it remains too early to replace all bare-metal stents with drug-eluting ones.
"If this (oral) drug is effective, I don't think anyone would want to pay more," he said.
More studies needed
Officials with Cordis say they doubt that the pill version of sirolimus can get close enough to the effectiveness of the drug-eluting stent.
"It's an interesting scientific question. And Dr. Waksman and Dr. Kereiakes are very good researchers. But oral sirolimus has been studied quite extensively," said Sam Liang, a vice president at Cordis who overseas the global stent market.
The amount of sirolimus needed to be effective in a pill is much higher than the amount used to coat a stent.
That means the pill poses a higher risk of side effects than the stent, Liang said.
Transplant patients - who take the pill for years - can experience a variety of side effects, including increased risk for infections, high blood pressure, anemia, acne and rash, insomnia, tremors and a long-term risk of cancer.
However, in previous, smaller trials of the pill in cardiac patients, most could tolerate the drug for a month. And heart patients are less likely to experience side effects that stem from long-term use, Waksman said.
Regardless of how the sirolimus study turns out, Kereiakes said more of these kinds of studies are needed. That's because the current system for reviewing new medicines and devices focuses on safety and effectiveness, but does not require new products to demonstrate cost-effectiveness, he said.
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