Abbott: Low Event Rates In Big One-Year Stent Study

A large study of Abbott Laboratories' (ABT) Xience drug-coated heart stent used in complex, "real-world" cases showed similar low rates of repeat procedures and major heart problems at one year as studies with simpler patient cases, Abbott said Thursday.

The data from the Spirit V study cover 2,663 patients outside the U.S. who had Xience stents installed to prop open their clogged heart arteries. It represents the first, big study of the Abbott device, which has become a leading product in the $4 billion global coated-stent market, in more complex cases.

The data were presented at the EuroPCR cardiology conference in Barcelona.

As a single-arm study, Spirit V doesn't include data from another type of stent to compare performance and show how Xience matches up against competition. Instead, Abbott noted how the study's statistics compare with statistics from prior clinical trials where Xience did look good against a rival device.

Such clinic trials for stents generally feature basic cases, and the Food and Drug Administration approvals have also covered simpler treatment circumstances. But coated stents are commonly used in off-label cases featuring patients with a variety of complex problems, such as multiple vessels that need unclogging, which creates interest among doctors in how stents really perform in those situations.

Among the one-year Xience data in the new Abbott study, there was a 1.8% rate of repeat procedures for the already treated area, a 0.7% rate of stent-related clots, a 5.1% cumulative rate of major adverse heart events and a 1.1% rate of cardiac death.

Abbott compared these results with data from a combined analysis from the Spirit II and Spirit III trials for Xience, which helped the company win European and U.S. approval to sell the device. These performance measures were similar or lower in the new study.

"It really continues to demonstrate that the product performs well in this population" of patients, said John Capek, executive vice president of Medical Devices at Abbott, in an interview.

Boston Scientific Corp. (BSX) also sells Xience under a different name - Promus - and then shares profits with Abbott under a deal linked to their purchase of Guidant Corp. three years ago.

-By Jon Kamp, Dow Jones Newswires; 617-654-6728; [e-mail]