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

다국어 초록 (Multilingual Abstract)

To assess the safety and efficacy of the novel Resolute (R‐) Onyx drug‐eluting stent (DES).
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.
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.
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%).
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.