Boston Scientific Stents Less Effective Than Rivals

-Bloomberg

03/30/2009 - Heart stents made by Boston Scientific Corp., the world’s biggest seller of the artery- clearing devices, were less effective in studies than those from Abbott Laboratories, Johnson & Johnson and Medtronic Inc.

Taxus Liberte, Boston Scientific’s 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 Abbott’s 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 Boston’s sales and marketing prowess,” said Tim Fischell, the director of cardiovascular research at Borgess Research Institute in Kalamazoo, in an e-mail. Given the stent’s showing in past trials, “it’s amazing that Taxus is used over J&J’s 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 company’s 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 they’ve been cleared with angioplasty.

Tough Weekend

The results for Xience and for 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 Cypher’s surprisingly low rate of triggering blood clots in the South Korean trial, called Zest, Smith said.

weekend’s session was tough on Boston Scientific,” especially the “surprisingly negative” results for Taxus Liberte in Zest, said Michael Weinstein, a J.P. Morgan Chase & Co. analyst in New York, in a note to clients today.

Still, Xience’s continued popularity will likely pump up Promus sales as well, “blunting the impact of any further decline in Taxus’s share position,” Weinstein said.

Good for Medtronic

Medtronic, whose share of the stent market had fallen to 9 percent in January, may also see its slide arrested by the positive results, said Rick Wise, a Leerink Swann & Co. analyst in New York, in another note. The company said this morning that it expected to start selling Endeavor in Japan in May, after regulators there approved the device.

Medtronic rose 25 cents, less than 1 percent, to $29.03 in composite New York Stock Exchange trading at 4:15 p.m. Boston Scientific dropped 24 cents, or 2.9 percent, to $7.96. J&J gained 18 cents to $53.01 and Abbott rose $1.29, or 2.8 percent, to $47.89.

With all four company’s stents performing relatively equally in past studies, the battle may come down to price, said Smith, the cardiologist who is director of the University of North Carolina’s Center for Cardiovascular Science and Medicine.

Drug-coated stents sell for $2,000 apiece, and the manufacturers so far haven’t shown any willingness to compete on cost, he said.

“The results we’re seeing in Zest and the other trials don’t 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 Medtronic’s Endeavor and Taxus Liberte. The study, partly funded by Medtronic, found Endeavor equally as effective as Taxus Liberte and safer.

Patients using Cypher needed a second procedure to open a reclogged artery 1.4 percent of the time, compared with 4.9 percent for Endeavor and 7.6 percent for Boston Scientific’s model, researchers said.

“There’s 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.”

Fewer Clots

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.

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 Scientific’s chief medical officer.

“This data doesn’t 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.

The second study, called Spirit 2, gave results for Xience patients at three years, the longest review yet of the Abbott stent’s performance.

Among 223 Xience users, the rate of deaths, heart attacks and repeat procedures stayed steady at 6.4 percent from years two to three, Abbott said in a statement.

Cardiac-Related Deaths

Among 73 Taxus users, the figure rose from 10.5 to 14.9 percent in the study, which Abbott funded. The rate of cardiac- related deaths was 0.5 percent for Xience patients in the third year, compared with 4.2 percent for Taxus.

“In the clinical outcomes that matter most, such as heart attacks, repeat procedures at the target lesion or death, Xience demonstrated a consistent reduction relative to Taxus out to three years,” said lead investigator Patrick Serruys, a cardiologist at Erasmus University in Rotterdam, in the statement.

A quarter of the Taxus stents were Liberte models while the rest were an older version, the statement said.

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