By Bruce Japsen
Chicago Tribune
Copyright 2007 Chicago Tribune Company
CHICAGO — Doctors are rethinking the use of stents for their heart patients.
The trend comes in the wake of studies questioning the necessity and safety of stents and the widespread adoption of better cholesterol-fighting drugs. Doctors say the drugs are proving to be a better option for some patients, further delaying their need for the device.
An estimated 1 million Americans a year receive stents to prop open clogged arteries and restore and maintain blood flow to the heart. The tiny metal scaffold-like devices are snaked into coronary arteries via a balloon-tipped catheter and have been hailed for relieving chest pain known as angina and reducing the risk of heart attacks and death.
But within the past year, studies on the newer drug-coated version of stents show a small risk of clots for some patients. And just as hospitals moved somewhat to older, cheaper bare metal stents to avoid a clotting risk, a widely distributed March study showed that drug therapy through the use of cholesterol-fighters known as statins, blood pressure pills and aspirin works as well as a stent.
The barrage of information has complicated doctors’ already complex task of treating patients for coronary artery disease, calling into question whether implants are always necessary.
That may not bode well for stentmakers such as North Chicago-based Abbott Laboratories, Boston Scientific Corp. and Johnson & Johnson.
The devicemakers are fighting for market share in a $6 billion worldwide industry that appears headed for flat-to-falling growth as large hospital operators and health insurance companies report decreases in the number of patients implanted with stents.
For doctors, the sometimes conflicting information has caused worry among their patients.
“It’s become more of a challenge because the information people have absorbed is not the full picture of what is going on out there,” said Dr. Charles Davidson, director of the catheterization laboratory at Northwestern Memorial Hospital in Chicago.
“If you don’t question what you do on a daily basis, you are not being responsible, so, appropriately, there is always a re-evaluation and rethinking,” said Dr. Peter Kerwin, medical director of the cardiac catheterization lab at Advocate Good Samaritan Hospital in Downers Grove.
Use levels off
At Advocate Health Care, the Chicago-area’s largest provider of medical care, which includes Good Samaritan and seven other area hospitals, usage of stents of all varieties has “leveled off,” a spokeswoman said.
Another large Chicago hospital operator, Resurrection Health Care, said it has seen a “leveling off and maybe even a slight decrease in stents purchased.”
In addition, one of the nation’s largest health insurance companies, Wellpoint Inc., parent of Chicago-based Unicare, said it anticipates a “decline in the number of procedures being performed due to” the March study, known as Courage, said Wellpoint spokesman Jim Gavin. The state’s largest health insurer, Blue Cross and Blue Shield of Illinois, says claims filed for drug-coated stent procedures are down since last fall and all stent usage has had little growth.
Abbott reports U.S. sales of bare-metal stents and related products are down 5 percent since March.
The implications to the consumer and employers who pick up the tab could be big. Drug-coated stents can cost $2,200 or more each, compared with $600 to $800 for the uncoated variety.
Wellpoint and other insurers say it is too early to know whether there could be cost savings, but these companies say they regularly evaluate such data in concert with doctors in their networks to make “medical necessity determinations.”
Abbott is looking to enter the U.S. market next year with a drug-coated stent known as Xience that thus far has not shown clotting issues, and officials at the medical-products giant believe they will be competitive as doctors opt for an alternative.
“There are still many patients who receive and benefit from the use of stents, but as in all fields of medicine the cumulative experience continues to allow us to sharpen the focus and get a better idea of what might work best in a given clinical situation,” said Dr. Sidney Smith, a past president of the American Heart Association.
Statistics from the Centers for Disease Control and Prevention indicate a continued drop in the number of deaths from heart disease, which doctors attribute to stents and drug-coated stents that lead to fewer incidents of restenosis, which results when arteries narrow again after treatment.
With the use of bare metal stents, arteries tend to narrow again 15 percent to 20 percent of the time so that stents had to be placed again, doctors say. Drug-coated stents help prevent recurrence of artery narrowing by slowly releasing medication that may help reduce plaque build up. Once drug-coated stents came onto the market in 2003, hospitals say, they reported at least a three-fold reduction in renarrowing of arteries.
The use of drug-coated stents, which had accounted for more than 90 percent of all stent usage at most hospitals, has now dipped into the 80th percentile at many hospitals, according to cardiologists.
“You would naturally see a reduction in repeat procedures because most [hospitals] use drug-coated stents now,” said Dr. Vincent Bufalino, president of the large 55-doctor suburban group Midwest Heart Specialists and chief of cardiology at Edward Hospital in Naperville. “Drug-eluting stents have been extremely successful.”
Repeat operations decrease
Doctors who took issue with the Courage study say any reduction in stenting is more likely attributed to drug-coated stents that have now been on the market for almost four years and have reduced the need for repeat stenting procedures. They also say Courage was sponsored in part by the cost-conscious Department of Veterans Affairs, an agency that some critics say has a vested interest in pushing cheaper medical treatments.
Meanwhile, doctors for millions of Americans on statin drugs such as Lipitor, Zocor and its generic equivalents say stents are becoming less of a necessity.
They point to decreasing death rates each year for Americans from heart disease.
As Bufalino puts it, Lipitor, the world’s top selling drug, “is practically in the drinking water” these days.
Devicemakers and doctors say all stents are different and should not be lumped in the same bucket when searching for a cause to the clotting issue. Stents have different drug coatings and are implanted with different systems.
Cardiology groups encourage patients who have drug-coated stents to take aspirin and a common anti-clotting drug known as Plavix for up to a year or longer.
And for patients who have had elective surgery such as a hip replacement and are told to stop taking Plavix, they should then take aspirin, Davidson said.