Abbott says Xience stent has low risks

Abbott Laboratories' Xience appears just as effective when used to prop open arteries in people with complicated conditions as it was in carefully chosen patients who enrolled in clinical trials, a company-funded study showed.

The data involving 2,663 patients found 5.1 percent of them, including diabetics and people with disease in more than one artery, died, had a heart attack or needed a repeat procedure within the first year. That's similar to the 5.3 percent seen in the company's studies used to get U.S. regulatory approval of the device.

The findings provide reassurance about Xience's long-term performance in typical patients, who are often sicker and have more health problems than those in clinical trials, according to researchers who presented the study at the EuroPCR medical meeting in Barcelona, Spain. The results may help boost sales of Xience and a sister product sold as Promus by Boston Scientific Corp., which hold about half the $4 billion worldwide market for the devices.

"This is a much broader use of the product, and is consistent with current care," said John Capek, executive vice president of medical devices at Libertyville Twp.-based Abbott. "We continue to gain market share and we're very pleased with the product's performance in the real world."

About 1.8 percent of patients needed a repeat procedure to open a clogged artery, less than the 3.1 percent seen in the earlier trials that closely monitored patients for signs that blood flow may be diminishing even without causing any symptoms. Death from heart complications occurred in 1.1 percent of patients and a blood clot known as a stent thrombosis occurred in 0.7 percent of patients within the first year.

The data "reflect a broad patient population that is more representative of the spectrum of disease seen in a typical interventional cardiology practice," said Eberhard Grube, chief of cardiology and angiography at the German Heart Center Sieburg, in a statement released by the company.