NEW YORK (Reuters Health) – Late lumen loss at 6 months is smaller with the Cre8 amphilimus-eluting stent than the Taxus paclitaxel-eluting stent in de novo percutaneous coronary intervention, according to the results of a European trial reported in the current online issue of the Journal of the American College of Cardiology.

There was also “a trend toward better 12-month clinical safety and efficacy results,” the authors report.

In their introduction, Dr. Didier Carrie, with Centre Hospitalier Universitaire Rangueil in Toulouse, France, and colleagues indicate that the polymer carrier of the antiproliferative agent in drug-eluting stents may be a factor in late stent thrombosis.

They compared outcomes with the polymer-free Cre8 stent versus the permanent-polymer Taxus Libterte stent in a randomized, single-blind study involving 323 PCI patients at 11 centers.

Angiographic in-stent late lumen loss at 6 months (the primary endpoint) was 0.14 mm in the Cre8 arm compared with 0.34 mm in the Taxus arm (p<0.0001), the researchers report.

At 12 months, the rate of target lesion revascularization was 4.7% in the Cre8 group versus 6.1% in the Taxus group (p=0.61), and corresponding rates of major adverse cardiac events (MACE) were 6.1% versus 6.8% (p=0.81), the report indicates.

“All patients will be clinically followed up to 5 years,” Dr. Carrie and colleagues note.

Meanwhile, they conclude, “The present noninferiority study achieved its primary endpoint, demonstrating that PF (polymer-free) Cre8 was noninferior, and even superior, to PP (permanent-polymer) Taxus in terms of 6-month LLL (late lumen loss).”

SOURCE:

A Multicenter Randomized Trial Comparing Amphilimus- With Paclitaxel-Eluting Stents in De Novo Native Coronary Artery Lesions

J Am Coll Cardiol 2012;59.