Premium
Safety and efficacy of the next generation Resolute Onyx zotarolimus‐eluting stent: Primary outcome of the RESOLUTE ONYX core trial
Author(s) -
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
Publication year - 2018
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.27322
Subject(s) - medicine , stent , surgery , clinical endpoint , lesion , randomized controlled trial
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 < 0.001 for noninferiority, P = 0.029 for superiority). At 8 months, clinically driven target lesion revascularization occurred in 3 patients (4.0%) and target lesion failure occurred in 5 patients (6.7%). Conclusions In‐stent late lumen loss is non‐inferior, and appears to be superior, with the thin‐strut novel composite wire R‐Onyx DES compared with Resolute DES. Continued evolution of stent design can improve angiographic outcomes in complex lesions, even in the current era of next‐generation DES.