Medtronic announced that the Resolute Onyx Drug-Eluting Stent (DES) met its primary endpoint of Target Lesion Failure (TLF) at one year for the treatment of coronary artery disease in extra-small vessels. Designed specifically for extra-small vessels, Resolute Onyx 2.0 mm DES yielded excellent clinical outcomes in the study compared to a pre-specified performance goal with patients experiencing significantly low rates of TLF at one year (5.0 percent, p<=0.001).
The study enrolled 101 patients with extra-small vessel sizes (2.0 mm - 2.25 mm) who received the Resolute Onyx 2.0 mm diameter DES across 20 sites in the United States and Japan. In the study, the events included in the TLF primary endpoint were low at one-year, as defined by low target-vessel MI (3 percent), low target lesion revascularization (2 percent) and no cardiac death. Additionally, Resolute Onyx DES showed no stent thrombosis. Results from the RESOLUTE ONYX 2.0 mm Clinical Study were presented at the 2017 EuroPCR Annual Meeting and simultaneously published in the Journal of the American College of Cardiology (JACC): Cardiovascular Intervention.
See: "First Report of the Resolute Onyx 2.0 mm Zotarolimus-Eluting Stent for the Treatment of Coronary Lesions with Very Small Reference Vessel Diameter." Matthew J. Price et al. JACC: Cardiovascular Interventions, May 2017 DOI: 10.1016/j.jcin.2017.05.004