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

• DOI: 10.1016/j.jcin.2016.10.037
• Publication Date: 2017-01-16T23:24:36Z
• Authors: Donald E. Cutlip; Kirk N. Garratt; Victor Novack; Mark Barakat; Perwaiz Meraj; Luc Maillard; Andrejs Erglis; Rajiv Jauhar; Jeffrey J. Popma; Robert Stoler; Sigmund Silber; Donald Cutlip; Suhail Allaqaband; Ronald Caputo; Nirat Beohar; David Brown; Kirk Garratt; Rajiv Jauhar; Jon George; Vincent Varghese; Mark Huth; German Larrain; Tommy Lee; Amir Malik; Scott Martin; Thomas McGarry; Charles Phillips; Alpesh Shah; Robert Stoler; Michael Ball; R. Jeffrey Price; Joseph Rossi; Charles Taylor; Thaddeus Tolleson; William Nicholson; Srinivas Kesanaku...; Mohammad Shoukfeh; Aloke Finn; Chandanreddy Devi...; Charles Shoultz; Mark Robbins; Radoslaw Kiesz; Pramod Menon; Daniel Weilenmann; Horst Sievert; Andrejs Erglis; Goran Stankovic; Jacques Berland; Nicolas Delarche; Jean Lou Hirsch; Luc Maillard; John Shayne; Antonio Serra; Antonio Fernandez...; Jean-Pierre Monas...; Sigmund Silber
• Keywords: Clinical endpoint; Target lesion

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.Polyzene-F-coated coronary stents have shown reduced thrombogenicity and inflammation in preclinical studies.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.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.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.