Heart stent makers brace for new heart studyMar 26, 2007 | AP Wall Street analysts and many doctors expect another potential setback for makers of stents when results of a blockbuster study Tuesday will answer whether an artery-opening procedure plus drugs is better than medication alone for lower-risk heart patients with chest pain.
It's the first big study to directly compare angioplasty procedures with drug therapy alone as a way to prevent heart attacks and deaths in non-emergency cases.
If the research reaches the conclusion many analysts and doctors expect that angioplasty offers little or no lifesaving benefit over drugs for these patients the finding would be the latest dose of bad news for makers of stents. The tiny mesh scaffolds are used in most angioplasties to keep vessels open after blockages have been cleared.
After new-model drug-coated stents reached the market in 2003, the global stent market including older bare-metal stents grew from about $2 billion a year to about $6 billion in 2005.
Drug-coated stents have been implanted in more than 6 million people worldwide a modern record for fastest use of a new medical device.
But use has fallen since new evidence emerged that drug-coated stents carry a slightly higher risk of triggering blood clots months or years later. Many doctors have returned to using the older bare-metal stents or doing bypass surgery instead of angioplasty until more is known.
The drug-coated stent market shrank last year and is expected to erode at a faster rate this year, due in part to anticipation of the newest heart study.
"This market went from zero to 100 mph, and now it's braking," said Citigroup analyst Matthew Dodds, who forecasts an 8 percent decline in overall stent sales this year, and slower market erosion through 2011.
For drug-coated stent makers such as Natick, Mass.-based Boston Scientific Corp. and New Brunswick, N.J.-based Johnson & Johnson, the shift has been costly, since drug-coated models cost around $2,100 apiece compared with $850 for bare-metal versions introduced more than a decade ago.
A stent is typically inserted into a heart artery during angioplasty, a procedure in which a miniature balloon is guided through a vessel in the groin and then inflated to flatten a clog and restore blood flow to the heart.
The stent keeps the artery open, and drug-coated ones ooze medication to keep scar tissue from forming and the vessel from squeezing shut again.
Angioplasty, with a cost ranging from about $10,000 to $38,000, is the top treatment for people suffering heart attacks. But as many as 85 percent of angioplasties are non-emergency and done for people with less severe blockages that cause recurrent chest pain.
The big study to be reported on Tuesday compared angioplasty plus optimal heart medications aspirin, beta blockers, ACE inhibitors and statins to lower cholesterol to medications alone. Results are to be presented Tuesday at the American College of Cardiology's annual meeting in New Orleans.
Pointing to earlier smaller studies, industry analysts and doctors believe angioplasties will be on the losing end.
"There's absolutely no indication" the study will show angioplasty is superior, said Thom Gunderson, an industry analyst with Piper Jaffray.
Dr. John Lopez, a cardiologist at the University of Chicago Hospitals, noted that the new study followed only patients whose heart conditions were stable, rather than those facing imminent risks. He believes that it's primarily higher-risk patients who benefit more from the artery-opening procedure.
"I'd be very surprised if there was a reduction in mortality," said Dr. William Maisel, a cardiologist at Beth Israel Deaconess Medical Center in Boston. "I suspect the bottom line we will be left with is that both options (angioplasty versus drugs only) are reasonable."
That result would mirror findings in recent studies including two within the past month that examined smaller groups.
If patients can't expect a better chance of long-term survival, angioplasty's cost may loom larger when it's elective, said Dr. David Cohen of St. Luke's Mid America Heart Institute in Kansas City, Mo.
Cohen said patients with stable heart problems, like the ones in the latest study, "probably should not be receiving this therapy (angioplasty) on a first-line basis."
Dr. Donald Baim, Boston Scientific's chief medical officer, said doctors should look beyond survival rates and consider whether angioplasty with stents relieves chest pain.
"The decision should be driven by the desire to limit chest pain with the least invasive alternative that's practical," Baim said.
Drug-coated stents accounted for about 89 percent of all stents implanted early last year, according to a study by Millennium Research Group, a Toronto-based firm that surveys doctors.
But that proportion fell to just 70 percent in February after more doctors opted for bare-metal versions because of the blood-clot fears from the drug-coated models.
Boston Scientific's drug-coated Taxus stent accounted for about 25 percent of the company's $2.1 billion in fourth-quarter sales down from 40 percent before the company bought Guidant Corp. for $27 billion last spring to diversify a medical devices portfolio overly dependent on Taxus.
In comparison, J&J is a far bigger company with revenue of $13.7 billion last quarter and far less dependent on its drug-coated Cypher stent, which nevertheless has been a key driver of J&J's profits in recent years.
In addition to hurting Boston Scientific and Johnson & Johnson, the shift away from drug-coated stents could also hit companies with next-generation drug-coated models that are just hitting European markets and are soon expected to arrive in the U.S. Such companies include North Chicago, Ill.-based Abbott Laboratories Inc., and Minnesota-based Medtronic Inc. and St. Jude Medical Inc.
Piper Jaffray's Gunderson foresees further damage if Tuesday's research results are as expected.
"No matter how well anticipated these results are, and no matter how the stock prices have adjusted to factor in the results we're all anticipating, there is still that impact from the headlines in the morning," he said.