Rival stent makers join forces on clot-risk study
Just nine months ago, Boston Scientific Corp. and Johnson & Johnson were battling each other in a brutal takeover war for Guidant Corp. Now the two companies are joining forces to study a health issue that threatens a key business of both firms: the risk of blood clots associated with drug-coated stents.
Along with two other stent makers, the companies said they will jointly fund a multi million-dollar study of 10,000 people who have drug-coated stent implants. Since the stents were introduced a few years ago, a small but significant number of patients with drug-coated stents have developed blood clots inside the devices, which can block blood flow to the heart.
One of the doctors leading the new trial, Dr. Charles Simonton, said the study will try to determine definitively whether drug-coated stents have significant clotting risks.
"We need to get to the bottom of this," said Simonton, director of clinical innovation and research at Carolinas Heart Institute of Charlotte, N.C. Simonton said that while the funding comes from industry, the design, analysis, and publication of the study will be independent.
"We have no relationship to industry," said Simonton, "There isn't one single company that's driving this research."
Dr. Marcia Angell , former editor of the New England Journal of Medicine, said, "If the funds are given at arm's length and the researchers have no other financial ties to the companies, then I don't see anything wrong with it." She said she couldn't remember another clinical study funded by more than one company.
Stents are tiny wire mesh tubes used to prop open arteries after they have been cleared of obstructions. Doctors found that a significant number of patients fitted with traditional stents suffered from restenosis, a condition in which scarring inside the artery shuts down the opening, sometimes requiring surgery.
To combat that, Johnson & Johnson and Boston Scientific introduced stents coated with drugs that leach into the bloodstream and suppress scarring, precluding the need for some patients to undergo another procedure.
Simonton has been following the long-term treatment of stent recipients through a registry he started in 2003. It now tracks 22,000 patients and is designed to compare the safety and efficiency of the main products in the drug-coated stent market, Johnson & Johnson's Cypher and Boston Scientific's Taxus.
The new study will monitor patients for blood clots for two years, a period in which Simonton said about 100 blood clots are expected to appear. Researchers will look at a variety of factors that may contribute to the clots.
The initial idea for the clot study came from Dr. Gregg W. Stone , a Columbia University cardiologist who will also lead the study. Speaking at the Transcatheter Cardiovascular Therapeutics conference yesterday in Washington, D.C., Stone said the study could help clear the "hyperbole and inaccuracies" that have plagued the drug-coated stent field as Boston Scientific and Johnson & Johnson have fought for market share.
Last evening, Stone also said that, based on his analysis of study data, it appears that Johnson & Johnson's drug-coated heart stents are just as likely to cause potentially fatal blood clots as those made by Boston Scientific. Those findings contradict J&J's assertions that its device, the Cypher, has a lower rate of blood clots than Boston Scientific's Taxus.
In April, Boston Scientific, based in Natick, paid $27.5 billion for Guidant, which makes defibrillators, beating out Johnson & Johnson. Besides Boston Scientific and Johnson & Johnson, the study will be funded by Abbott Laboratories Inc. and Medtronic Inc.
Jeffrey Krasner can be reached at krasner@globe.com. 