Early Data Show Promise for Extended-Elution DES
Endeavor Resolute stent employs novel polymer blend and improves minimal lumen diameter.
The Endeavor Resolute stent showed low late loss, minimal neointimal hyperplastic in-growth and low adverse clinical events in four-month data reported yesterday by Ian Meredith, MD, PhD, of Monash Medical Centre in Melbourne, Australia.
The RESOLUTE trial enrolled a total of 130 patients with native coronary artery lesions 14 mm to 27 mm in length. Clinical, angiographic and intravascular ultrasound data from four-month follow-up were available on 30 patients. In the four-month subset, there was one Q-wave MI and no other major cardiac adverse events. As expected, there were no stent thromboses or target vessel revascularizations.
Minimal lumen diameter was improved with stent implantation (Table). At four months, in-stent and in-segment late losses were low, achieving the primary endpoint. The stent did not limit flow, as post-implantation external elastic volume was 345.5 mm3 compared with 337.5 mm3 at four-month follow-up.
Stent volume was also not significantly affected, while neointimal volume increased from 0.42 mm3 post-implantation to 3.72 mm3 at four-month follow-up.
Incidence of incomplete apposition at four-month follow-up was 10%.
Stent design
The Endeavor Resolute (Medtronic) stent retains three components of the Endeavor stent – the cobalt chromium stent, Endeavor delivery system and zotarolimus – and adds the BioLinx polymer to improve biocompatibility and extend the drug elution.
The goal of delayed elution is to match the typical delayed healing times of complex lesions. The polymer combines a hydrophilic component that is in direct contact with the vessel wall, while maintaining an extended elution of zotarolimus via the control of the hydrophobic polymer.
The limitations of this trial are that it as an uncontrolled observational study, and should therefore be viewed as hypothesis-generating rather than scientific evidence, said commentator Pedro Moreno, MD, of Mount Sinai Medical Center in New York.