SAN FRANCISCO | New clinical trial results appear to give Abbott’s everolimus-eluting coronary artery stent (Xience) a leg up as the device of choice in percutaneous coronary interventions.

The trials, presented during the Transcatheter Cardiovascular Therapeutics meeting here, compared the everolimus-eluting stent to the paclitaxel-eluting (Taxus) stent with respect to clinical endpoints of death, myocardial infarction and target vessel failure. Previous trials had used repeat angiography to determine success of the devices.

‘New standard’
“These results with the Xience V stent demonstrate enhanced safety and efficacy compared with the Taxus Express stent in this large-scale study without routine angiographic followup (and) set a new standard for event-free survival after drug-eluting stent implantation,” said Dr. Gregg Stone, director of the Cardiovascular Research and Education Center for Interventional Vascular Therapy at New York-Presbyterian Hospital and Columbia University in New York.

One year after stent implantation, 4.2% of everolimus-eluting stent recipients and 6.8% of patients treated with the paclitaxel stent had experienced the primary endpoint of target lesion failure—a composite of cardiac death, target-vessel myocardial infarction and ischemia-driven target lesion revascularization.

These results easily met the test for non-inferiority but also showed statistical superiority of the everolimus-eluting stent.

Diabetic patients
However, among patients who were diagnosed as being diabetic at baseline, there were no statistical differences in outcomes based on which stent was used. Dr. Stone said that for the non-diabetic patient, he considers the everolimus-eluting stent to be the device of choice in performing percutaneous coronary interventions.

In the so-called SPIRIT IV trial, a team of international researchers recruited 3,690 patients.

Dr. Stone noted the large number of patients provided the trial with greater statistical power.

Real-world situation
Researchers also presented results of the COMPARE trial in which physicians at one institution tracked how well the everolimus-eluting stent held up in a real-world situation that included all comers, without the specified exclusions of the SPIRIT trials. The trial randomized 1,800 patients to either the paclitaxel or the everolimus stents.

After 12 months, the everolimus stent came out on top again, said Dr. Peter Smits, an interventionist at Maasstad Hospital in Rotterdam, the Netherlands.

He reported a statistically significant 2.9% difference in the primary endpoint, a composite of death, non-fatal myocardial infarct and the need for target-vessel revascularization.

About 6.2% of the patients implanted with the everolimus-eluting stent experienced the clinical endpoint compared with 9.1% of the patients implanted with the paclitaxel-eluting devices.

“In an all-comer population,” Dr. Smits said, “reflecting real-world experience, implantation of the everolimus-eluting Xience V stent significantly reduced major adverse clinical events when compared with the paclitaxel-eluting Taxus Liberte stent.”

He said the main differences between the two stents were the ability of the everolimus stent to reduce early stent thrombosis and to avoid the need for target lesion revascularization.