Stent Showdown Gives Edge to J&J
Many interpretation of the stent studies - Doc
Of Three Studies vs. Taxus, Boston Scientific's Model, Cypher Shows Better in Two
By RON WINSLOW
Staff Reporter of THE WALL STREET JOURNAL
March 7, 2005; Page B4
ORLANDO, Fla. -- A highly anticipated head-to-head study between two hot-selling heart devices marketed by Johnson & Johnson and Boston Scientific Corp. was essentially a draw, but another, less-heralded study found the J&J product superior. A third study among diabetic patients also favored the J&J device.
The studies were among several reports presented at the annual scientific meeting of the American College of Cardiology that injected new energy into an already fierce marketing war between the two companies and some emerging rivals for the $5 billion global market for devices called drug-eluting stents. Overall, the results suggest that Johnson & Johnson's stent, called Cypher, performs better than the Taxus device from Boston Scientific, especially for more complicated cases.
"Both are very good stents," said Valentin Fuster, director of cardiology research at Mount Sinai School of Medicine, New York, who wasn't an author of any of the studies. But taken together, the new studies show "you just have better results with Cypher."
Boston Scientific disputed that assessment. Both of the larger studies had elements favoring each side, said Paul LaViolette, chief operating officer. "The data overall show the programs are roughly equivalent." The company said the J&J study in particular confirmed the strong safety and efficacy record of the Taxus stent.
Stents are tiny metal scaffolds that doctors use to keep coronary arteries open after angioplasty. Coating them with drugs is a recent advance that sharply reduces chances the stents will reclog -- a process called restenosis -- and cause a recurrence of chest pain. Johnson & Johnson's Cypher, marketed by its Cordis Corp. unit, was first on the market, but Boston Scientific's version, approved last year, has since claimed a market share of 60% to 65%.
Johnson & Johnson launched its 1,386-patient study, called Reality, to show its device was superior to Taxus. While some findings favored its device, data presented yesterday failed to clearly prove superiority, and instead showed that both devices performed similarly and very effectively.
A second study, done independently (without corporate support) by Swiss researchers, and involving 1,005 patients, found that Cypher significantly reduced a combination of major adverse events -- including death, heart attack and the need for repeat procedures: Among 500 Cypher patients, 6.2% had such an event, compared with 11% of the 505 Taxus patients. Almost all the events were repeat procedures.
"The data we have generated indicate the [Cypher] sirolimus-eluting stent is superior," said Stephan Windecker, head of the cardiac catheterization laboratory at University Hospital, Bern, Switzerland and lead author of the large independent study. He said his hospital, which alternates between the two stents, will likely switch over to Cypher based on the findings.
But Dr. Windecker's data came from patients treated at two hospitals and may not be as influential as those from multicenter studies. (The Johnson & Johnson study included patients from 90 European hospitals.) Other cardiologists may await further data before reaching firm conclusions.
A smaller, third paper, also independently funded, comparing the stents in 250 diabetic patients -- among the most complicated for treating heart blockages -- also favored Cypher: restenosis, defined as a renarrowing of the treated vessel by at least 50%, occurred in 17% of patients who got a Taxus stent, compared with 6.9% treated with Cypher.
In an unexpected result, the Johnson & Johnson study, as presented by Marie-Claude Morice, head of interventional cardiology at Institut Hospitalier Jacques Cartier, Massy, France, found that blood clots formed in the stents of 12 of 669 Taxus patients and in three of 684 Cypher patients who were evaluated within 30 days of the procedure. Clots are a serious problem that can lead to heart attack or death. But other researchers said that while the issue was a cause of concern that needed to be followed, the study was far too small to determine whether the differences in incidence of clots between the devices were significant.
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