Author + information
- Matthew J. Price,
- Richard Shlofmitz,
- Douglas Spriggs,
- Thomas Haldis,
- Paul Myers,
- Alexandra Popma-Almonacid,
- Akiko Maehara,
- Beth Moe,
- Yun Peng and
- Roxana Mehran
Background: The goal of the RESOLUTE ONYX Core trial was to evaluate the safety and efficacy profile of the Resolute OnyxTM zotarolimus-eluting stent (ZES, Medtronic). The Resolute Onyx ZES is composed of a composite wire material with an outer shell of the same cobalt chromium alloy as its predecessor Resolute IntegrityTM ZES, but with a platinum-iridium inner core and swaged struts designed to improve radiopacity and deliverability while maintaining radial strength.
Methods: This was a prospective, single-arm study that assessed the safety and efficacy of the Resolute Onyx stent. Patients were eligible for inclusion if there was clinical evidence of ischemic heart disease, stable or unstable angina, and up to 2 de novo target lesions of <35mm in length with reference vessel diameter of 2.25 to 4.2 mm. Clinical follow-up was performed at 30 days and 6, 8 and 12 months. The primary endpoint was in-stent late lumen loss by quantitative coronary angiography at 8-months post-procedure which was compared with a Resolute historical control with a non-inferiority margin of 0.20mm. Propensity score method was used to adjust for differences in baseline characteristics between the two groups.
Results: A total of 75 patients with 85 lesions were enrolled. The mean age was 66 years, 73% were male, 32% had diabetes mellitus, and 16% were current smokers. Mean lesion length was 14.28 ± 6.68 mm and the mean reference vessel diameter was 2.57 ± 0.48 mm. The primary endpoint of in-stent late lumen loss at 8 months was 0.24 ± 0.39 mm for Resolute Onyx compared with 0.36 ± 0.52 mm for the historical Resolute control (p<0.001 for non-inferiority and p=0.029 for superiority). Clinical endpoints at 8 months were: target lesion failure 6.7%, clinically-driven target lesion revascularization 4.0%, cardiac death 0%, target vessel myocardial infarction 2.7% and definite/probable stent thrombosis 1.3%.
Conclusions: Resolute Onyx is designed with thin-strut novel composite wire that provides enhanced radiopacity, with similar drug density than the predecessor Resolute Integrity but an overall lower drug load in most stent sizes. Complete 12-month clinical results with Resolute Onyx will be presented.
Poster Hall, Hall C
Friday, March 17, 2017, 3:45 p.m.-4:30 p.m.
Session Title: Coronary Intervention in Interventional Cardiology: Advanced Device Use
Abstract Category: 21. Interventional Cardiology: Coronary Intervention: Devices
Presentation Number: 1155-151
- 2017 American College of Cardiology Foundation