Safety and efficacy of the next generation Resolute Onyx zotarolimus‐eluting stent: Primary outcome of the RESOLUTE ONYX core trial

• Published in: Catheterization and cardiovascular interventions 2018-08, Vol.92 (2), p.253-259
• Main Authors: Price, Matthew J., Shlofmitz, Richard A., Spriggs, Douglas J., Haldis, Thomas A., Myers, Paul, Popma Almonacid, Alexandra, Maehara, Akiko, Dauler, Michelle, Peng, Yun, Mehran, Roxana
• Format: Article
• Language: English
• Subjects: Angina; Chromium; Chromium base alloys; Chromium plating; Cobalt; Cobalt base alloys; Diabetes mellitus; drug eluting stents; Implants; Ischemia; late lumen loss; Lesions; percutaneous coronary intervention; Platinum; Stents; Struts; zotarolimus
• ISSN: 1522-1946; 1522-726X
• DOI: 10.1002/ccd.27322

Objectives To assess the safety and efficacy of the novel Resolute (R‐) Onyx drug‐eluting stent (DES). Background The R‐Onyx DES consists of a composite wire with an outer shell of cobalt chromium alloy and a platinum‐iridium inner core to enhance radiopacity, with thinner, swaged struts and modified stent geometry compared with the predicate Resolute DES, resulting in a slightly lower total drug load in most sizes. Methods This was a prospective, single‐arm non‐inferiority trial compared with a historical control. Patients with stable angina/ischemia and up to 2 de novo target lesions ≤35 mm long with reference vessel diameter (RVD) of 2.25–4.2 mm were enrolled. The primary endpoint was late lumen loss at 8‐month follow‐up. Propensity‐score adjusted outcomes from the single‐arm RESOLUTE‐US trial served as the control. Results Seventy‐five patients (85 lesions) were enrolled. Mean patient age was 66 ± 9 years, 73% were male, and 32% had diabetes. Mean lesion length was 14.28 ± 6.68 mm, mean RVD was 2.57 ± 0.48 mm, and 86% of lesions were class B2/C. In‐stent late lumen loss at 8 months was 0.24 ± 0.39 mm with R‐Onyx DES compared with 0.36 ± 0.52 mm with Resolute DES (P