First Report of the Resolute Onyx 2.0-mm Zotarolimus-Eluting Stent for the Treatment of Coronary Lesions With Very Small Reference Vessel Diameter

• Published in: JACC. Cardiovascular interventions Vol. 10; no. 14; pp. 1381 - 1388
• Main Authors: Price, Matthew J., Saito, Shigeru, Shlofmitz, Richard A., Spriggs, Douglas J., Attubato, Michael, McLaurin, Brent, Popma Almonacid, Alexandra, Brar, Sandeep, Liu, Minglei, Moe, Elizabeth, Mehran, Roxana
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 24.07.2017
• Subjects: Aged; Angina, Stable - diagnostic imaging; Angina, Stable - therapy; Angina, Unstable - diagnostic imaging; Angina, Unstable - therapy; Cardiovascular Agents - administration & dosage; Coronary Angiography; Coronary Artery Disease - diagnostic imaging; Coronary Artery Disease - therapy; Coronary Restenosis - etiology; Coronary Vessels - diagnostic imaging; drug-eluting stent(s); Drug-Eluting Stents; Female; Humans; Japan; Male; Middle Aged; percutaneous coronary intervention; Percutaneous Coronary Intervention - adverse effects; Percutaneous Coronary Intervention - instrumentation; Prospective Studies; Prosthesis Design; reference vessel diameter; Resolute Onyx; restenosis; Sirolimus - administration & dosage; Sirolimus - analogs & derivatives; stent(s); Time Factors; Treatment Outcome; United States; zotarolimus; RVD; restenosis; stent(s); reference vessel diameter; ZES; Resolute Onyx; QCA; drug-eluting stent(s); TLF; percutaneous coronary intervention; zotarolimus; DES; R-Onyx; MACE; PCI; TLR; MI
• ISSN: 1936-8798; 1876-7605; 1876-7605
• DOI: 10.1016/j.jcin.2017.05.004

The aim of this study was to explore the safety and efficacy of a dedicated drug-eluting stent for the treatment of coronary lesions with very small reference vessel diameter (RVD). Smaller RVD is associated with increased risk for restenosis and target lesion failure (TLF) after stent implantation. This was a prospective, single-arm, multicenter trial of the Resolute Onyx 2.0-mm zotarolimus-eluting stent. The primary endpoint was 12-month TLF, which was compared with a pre-specified performance goal. Subjects with stable or unstable angina or ischemia, target lesions ≤27 mm in length, and RVD ≥2.0 and <2.25 mm were eligible for enrollment. A subset of subjects underwent follow-up angiography at 13 months post-procedure. A total of 101 subjects with 104 lesions were enrolled. The mean age was 67.3 ± 9.6 years, 47% of subjects had diabetes, the mean lesion length was 12.6 ± 6.3 mm, and the mean RVD was 1.91 ± 0.26 mm. The rate of TLF at 12 months was 5.0%, fulfilling the pre-specified performance goal of 19% (p < 0.001). The rates of target lesion revascularization and target vessel myocardial infarction were 2.0% and 3.0%, respectively. There were no episodes of stent thrombosis. In-stent late lumen loss was 0.26 ± 0.48 mm, and the rate of binary restenosis was 12.0%. In this first report of a drug-eluting stent with a dedicated size to treat lesions with RVD <2.25 mm, the Resolute Onyx 2.0-mm zotarolimus-eluting stent was associated with a low rate of TLF and late lumen loss, without a signal for stent thrombosis. This novel-sized drug-eluting stent appears to be a feasible option for the treatment of coronary lesions in extremely small vessels. (Medtronic Resolute Onyx 2.0 mm Clinical Study; NCT02412501) [Display omitted]