Next-Generation Ultra-Thin Stents Evaluated

It may be too early to determine whether a new generation of ultra-thin stents do a better job than standard stents, but a Swiss study concluded the new product is at least not inferior.

The stent has ultrathin cobalt-chromium struts coated with a biodegradable polymer containing sirolimus, a drug known to prevent restenosis.

Reporting at the European Society of Cardiology meeting in Barcelona, Spain Sept. 1, Thomas Pilgrim, MD, said the new devices are promising.

The problem in determining whether they are superior to existing devices is that the latest stents available are also quite good.

“Because of the low event rates of contemporary stents it is becoming increasingly difficult to establish superiority of new stents in clinical trials,” he said.

The researchers compared how 2,119 patients did with two types of stents. One group (1,063 patients) got the experimental ultrathin sirolimus-eluting stents. The rest got the everolimus-eluting stents already on the market.

Both devices were equally safe and effective as of the end of the 12-month study period, Pilgrim said.

The new devices may be better for patients who presented with ST-segment elevation myocardial infarction, 407 patients studied.

Getting the experimental ultra-thin stent may have been the reason that fewer patients in that subgroup in his study died or had a second attack caused by stent failure. That happened to seven patients of those 407 patients who got the experimental stent vs. 17 patients who got the other device.

But the numbers of patients in that subgroup were too low to be deemed significant, Pilgrim said.

“We cannot exclude that these findings are due to chance alone,” he said. The study was also reported online Sept. 1 in The Lancet.

The research was funded by the University of Bern and Biotronik. The device company paid Pilgrim’s travel expenses to the meeting.