Novel Biodegradable Polymer DES Shows Efficacy, Long-term Safety

A novolimus-eluting stent (NES) with a biodegradable polymer has demonstrated 6-month angiographic superiority over a zotarolimus-eluting stent (ZES) and comparable long-term safety. Three-year results from the EXCELLA BD trial were presented Monday by Stefan Verheye, MD, PhD, of the ZNA Middelheim Hospital in Belgium.

For the study, investigators randomized 146 analyzable patients in a 3:1 ratio to PCI with the DESyne BD NES (Elixir Medical) or the Endeavor ZES (Medtronic). The CE-marked DESyne BD device features a cobalt-chromium platform and a polylactide-polymer coating containing a low dose of drug (5 mcg/mm of stent length).

At 6 months, in-stent late lumen loss (primary endpoint), in-stent binary restenosis >50% and percent neointimal volume all were lower in the NES group. Rates of a device-oriented composite of cardiac death, target vessel MI and clinically indicated target lesion revascularization (TLR) were low and similar between the groups at 6 months and 3 years (see Table). In addition, no cases of stent thrombosis were reported in NES patients through 3 years.

“This randomized study establishes the safety and effectiveness of a DES with a biodegradable polymer, which after 6 to 9 months leaves nothing behind but the bare-metal stent,” Verheye told TCT Daily. “After a fully bioresorbable scaffold, this could be the next best thing.”

Disclosures: 

• Verheye reports serving as a consultant to Elixir Medical.