In its first human clinical trial, the novel Biolimus A9-eluting stent appears to be safe without increased risk of early major adverse cardiac events, according to research presented at the Sixteenth Annual Transcatheter Cardiovascular Therapeutics Scientific Symposium.

"We are very excited by the outcome of this first-in-man study that demonstrates that Biolimus A9 could be a very promising anti-restenosis therapy," said A. Abizaid, MD, PhD. "The positive results to date will allow us to continue our clinical testing in a greater number of patients."

The STent Eluting A9 bioLimus Trial in Human (STEALTH) trial evaluated
the safety and efficacy of the Biolimus A9-eluting stent compared with a
bare metal stent in treatment of coronary lesions. American researchers examined 120 patients in a multi-center, 2:1 randomized blinded prospective clinical study.

Although the results are still blinded, the overall outcomes suggest that the stent is safe and effective in humans being treated for coronary lesions.

"In both arms of the study, no more than 1.4 percent of patients had stent thrombosis, myocardial infarction or target lesion revascularization within 30 days following the procedure," explained Abizaid. "We expect the final six-month data and un-blinded results to provide us with the evidence we need to commence a second-in-man trial."

Biolimus-A9 is a macrocyclic lactone (rapamycin analogue) with chemical modifications at position 40 of the rapamycin ring. Although Abizaid is cautious about being too optimistic based on the results of one study, he believes that if the data continue to show positive outcomes, Biolimus could emerge as an important anti-restenosis therapy. "Future studies are still needed to determine the stent's long term effectiveness, as well as its overall place in the growing field of interventional cardiology," he said.