6-Month Xience Diabetic Data Little-Changed

Abbott Laboratories Inc. (ABT) released more data for its Xience V drug-coated stent late Wednesday, showing very similar performance at six months in avoiding blood-vessel diameter changes with complex diabetic patients as with the other cases.

Other data in the Spirit II trial, meanwhile, showed no additional major heart problems in the six-to-nine-month timeframe.

Stents are tiny mesh tubes that prop open arteries, and drug-coated stents like Xience use medication to slow cell growth that can re-narrow arteries and lead to complications. Diabetic patients present more challenging stent cases, and also make up a sizable portion of stent recipients.

A subset of diabetic patients in the 300-patient Spirit II trial showed "nearly identical rates of in-stent late loss," or a measure of how vessel diameter changes at six months, Abbott said in a release. Abbott presented the latest Xience details at the Transcatheter Cardiovascular Therapeutics conference in Washington, D.C.

The Abbott Park, Ill., company garnered attention last month with the release of six-month data that showed Xience had better late-loss performance than Taxus, a popular stent made by industry giant Boston Scientific Corp. (BSX).

For diabetic patients in the trial, in-stent late loss was 0.15 millimeters for Xience versus 0.39 millimeters for Taxus at six months, Abbott said. This is comparable with the study's overall six-month results.

"We believe these results have the potential to differentiate Xience V for physicians with patients whose cases present more challenges for treatment," said John Capek, president of cardiac therapies in Abbott's vascular business, in the release.

The issue of stent safety has been a dominating topic at the cardiology conference. Specifically, talk and presentations have focused on the issue of late-stent thrombosis, or clots that form around a stent months or years after implantation.

Abbott said there were no additional cases of major adverse cardiac events or stent thrombosis in the Spirit II trial between six and nine months. In that time span, the major heart event rate stood at 2.8%, while the stent thrombosis rate stood at 0.5%, Abbott said.

Abbott significantly bolstered its stake in the stent sector through its April acquisition of Guidant Corp.'s vascular and endovascular business, a deal that included Xience. Abbott recently announced plans to drop its home-grown ZoMaxx drug-coated stent program amid poor data, but also just introduced the Xience in Europe slightly ahead of schedule.

Speaking during a conference with analysts on Monday, Capek said "the customer feedback has been remarkable" with Xience after just a few weeks on the market. He also said Abbott remains on track to introduce the stent in the U.S. in the first half of 2008 and in Japan in 2009, pending regulatory approval.

Xience data has bearing for Boston Scientific beyond the Taxus comparison, as Boston Scientific bought the bulk of Guidant through April's deal and agreed with Abbott to share rights to the Guidant stent program. Boston Scientific announced last week that it had received regulatory approval to market Promus, its version of Xience, in the European Union.