9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System

• Published in: JACC. Cardiovascular interventions 2017-01, Vol.10 (2), p.160-167
• Main Authors: Cutlip, Donald E., MD, Garratt, Kirk N., MD, Novack, Victor, MD, PhD, Barakat, Mark, MD, Meraj, Perwaiz, MD, Maillard, Luc, MD, PhD, Erglis, Andrejs, MD, Jauhar, Rajiv, MD, Popma, Jeffrey J., MD, Stoler, Robert, MD, Silber, Sigmund, MD
• Format: Article
• Language: English
• Subjects: Aged; Angioplasty, Balloon, Coronary - adverse effects; Angioplasty, Balloon, Coronary - instrumentation; Cardiovascular; Coated Materials, Biocompatible; Coronary Angiography; Coronary Artery Disease - diagnostic imaging; Coronary Artery Disease - therapy; Coronary Restenosis - diagnostic imaging; Coronary Restenosis - etiology; Coronary Thrombosis - diagnostic imaging; Coronary Thrombosis - etiology; Coronary Vessels - diagnostic imaging; Female; Humans; Male; Middle Aged; Nanoparticles; Organophosphorus Compounds - chemistry; Polymers - chemistry; Predictive Value of Tests; Prospective Studies; Prosthesis Design; restenosis; Risk Factors; stent(s); Stents; thrombosis; Time Factors; Treatment Outcome
• ISSN: 1936-8798; 1876-7605
• DOI: 10.1016/j.jcin.2016.10.037

Abstract Objectives The aim of this study was to assess the safety and effectiveness of the COBRA Polyzene-F NanoCoated Coronary Stent System (CeloNova Biosciences, San Antonio, Texas) for the treatment of de novo coronary artery lesions. Background Polyzene-F–coated coronary stents have shown reduced thrombogenicity and inflammation in preclinical studies. Methods Patients with de novo coronary artery lesions meeting eligibility criteria were enrolled in a nonrandomized, prospective clinical trial. The primary endpoint was target vessel failure (TVF) (defined as a composite of cardiac death, myocardial infarction, or clinically driven target vessel revascularization) at 9 months. A pre-specified subset was planned for routine repeat angiographic follow-up at 9 months. The powered secondary endpoint was mean late lumen loss (LL). The comparator was a performance goal derived from meta-analysis of historical bare-metal stent trials of 19.62% for TVF and 1.1 mm for LL. Other secondary endpoints were clinically driven target lesion revascularization and definite or probable stent thrombosis. Results Of 296 enrolled patients, 287 (97%) completed primary endpoint analysis; 130 were planned for angiographic follow-up and 115 (88%) completed. At 9 months, TVF had occurred in 33 patients (11.5%; upper 95% confidence boundary: 15.07%), including 1 (0.3%) cardiac death, 20 (7.0%) myocardial infarctions (17 periprocedural), and 17 (5.9%) target vessel revascularizations. LL was 0.84 ± 0.48 mm (upper 95% confidence boundary: 0.92). Target lesion revascularization occurred in 13 patients (4.6%). There were no stent thrombosis events. Conclusions The COBRA Polyzene-F stent met performance goals for TVF and LL at 9 months. There was an excellent safety profile, with infrequent late myocardial infarction and no stent thrombosis.