Boston Scientific Stents Less Effective Than Others In Studies

March 30, 2009 by Philbert Ross
Filed under: Drug 

Taxus Liberte, Boston Scientifics newest stent, required more repeat procedures than products from Medtronic and J&J in a South Korean study reported yesterday at the American College of Cardiology meeting in Orlando, Florida. In a separate trial, two Taxus models were linked with an 88 percent higher risk of heart-related deaths than Abbotts market-leading Xience stent.

Stent makers are competing for a $4 billion market. In January, seven months after its U.S. debut, Xience had grabbed 28 percent of the market, Boston Scientific said in a call with investors. Taxus, with 24 percent, was third behind the 25 percent recorded for a Xience copy, called Promus, that is licensed from Abbott and sold by Boston Scientific.

Market leadership is “just a credit to Bostons sales and marketing prowess,” said Tim Fischell, the director of cardiovascular research at Borgess Research Institute in Kalamazoo, in an e-mail. Given the stents showing in past trials, “its amazing that Taxus is used over J&Js Cypher,” which has just 14 percent of the market.

Boston Scientific, based in Natick, Massachusetts, last year introduced both Taxus Liberte, an updated version of the companys existing drug-coated stent, and Promus, the Xience copy it licenses from Abbott Park, Illinois-based Abbott. Stents are tiny mesh devices that keep arteries from closing down after theyve been cleared with angioplasty.

Unlikely to Change

The results for Xience and Cypher, made by New Brunswick, New Jersey-based J&J, are unlikely to change market share, said Sidney Smith, a University of North Carolina cardiologist, in a telephone interview. Xience, introduced in July, is already the top-selling stent. Also, some doctors were skeptical about Cyphers surprisingly low rate of triggering blood clots in the South Korean trial, called Zest, Smith said.

With all four companys stents performing relatively equally in past studies, the battle may come down to price, said Smith, director of the schools Center for Cardiovascular Science and Medicine.

Drug-coated stents sell for $2,000 apiece, and the manufacturers so far havent shown any willingness to compete on cost, he said.

“The results were seeing in Zest and the other trials dont really argue for choosing one stent over another,” Smith said. “In that setting, price is going to become a bigger factor to consider.”

Cypher More Effective

The Zest researchers found Cypher more effective at keeping arteries open, and at least as safe, as Medtronics Endeavor and Taxus Liberte. The study, partly funded by Medtronic, found Endeavor equally as effective as Taxus Liberte and safer.

“Theres a significant difference in disfavor of Endeavor” and for Cypher, said Stephan Windecker, a cardiologist at the University of Bern in Switzerland.

The trial results demonstrate “not all drug-eluting stents are the same,” said Christopher Allman, a J&J spokesman, in an e-mail. “Only Cypher has shown sustained patient outcomes now out to six years, which is another point of differentiation among drug eluting stents.”

The study showed Endeavor to be “non-inferior” to Cypher in terms of safety, while it had 29 percent fewer deaths, heart attacks and repeat procedures than the better-selling Liberte, said Joseph McGrath, a Medtronic spokesman, in an e-mail.

Fewer Clots

The trial found a much lower rate of clotting for Cypher and higher rates of repeat procedures for Liberte than past studies, so conclusions should be tempered by those past results, said Donald Baim, Boston Scientifics chief medical officer.

“This data doesnt jibe with what we know with all the other trials,” Baim said in an interview.

Boston Scientific has kept its grip on the market partly due to its two offerings, Taxus Liberte and Promus, Baim said. Each has a different drug coating and underlying architecture that serve different types of patients, he said.

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