Low Event Rates with EES Sustained at 2 Years

SAN FRANCISCO, CALIF.—Results from the prospective, single-arm XIENCE V USA trial showed that the everolimus-eluting stent was associated with low event rates in patients observed in a clinical setting at 2 years.

Slightly more than 82% of patients used dual antiplatelet therapy (DAPT) at one year, which dropped to 64.1% at 2 years. Nonetheless, the rate of stent thrombosis remained below 1% at 2 years. Two-year follow-up also revealed that other clinical endpoints, including stent thrombosis, MI and cardiac death, were similar to the rates observed at 1 year (see Table).

“We all have lingering angst about stent thrombosis and especially late stent thrombosis because these are permanent implants,” said Mitchell W. Krucoff, MD, professor of medicine and cardiology at Duke University Medical Center and director of the cardiovascular devices unit at the Duke Clinical Research Institute, Durham, N.C., who was lead author on the study. “What we’re seeing as we look at the 2-year report, at least in this second generation platform, is that sites appear to heal at least as well as they do with BMS. If that is in fact what’s happening, then combined with a restenosis rate that’s well below half of what we’re seeing with bare metal stents, we finally have both safety and effectiveness in a single platform. That’s very exciting.”

Study details

As a condition of approval for the EES (Xience V; Abbott Vascular), the FDA required the stent’s manufacturer to conduct XIENCE V USA, a multicenter trial in an all-inclusive, consecutively enrolled population in a real world clinical setting. An independent committee adjudicated clinical endpoint events including stent thrombosis, cardiac death, MI and revascularization.

A total of 4,382 patients completed 2-year follow-up. More than one-third of the population had ACS and diabetes at baseline.

Quality-of-life improvements

David R. Rutledge, PharmD, director of worldwide clinical science for Abbott Vascular and trial co-author, added that not only did the EES improve clinical outcomes, it also improved quality of life for patients.

“We were pleased to see the low event rates in terms of stent thrombosis that we initially saw at 1 year remain low at 2 years,” he said. “From the very beginning when we were designing this new technology, we were expecting low event rates and that those rates would remain low over time.

“From the patient’s perspective, they are noticing immediate improvements in QOL and angina symptoms,” Rutledge said. “The patients are saying they feel better and are not complaining about angina.”