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

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 VargheseMark 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 Kesanakurthy, Mohammad Shoukfeh, Aloke Finn, Chandanreddy Devireddy, 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-Ortiz, Jean Pierre Monassier, Sigmund Silber

Research output: Contribution to journalArticle

19 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)160-167
Number of pages8
JournalJACC: Cardiovascular Interventions
Volume10
Issue number2
DOIs
StatePublished - Jan 23 2017
Externally publishedYes

Keywords

  • restenosis
  • stent(s)
  • thrombosis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Fingerprint Dive into the research topics of '9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System'. Together they form a unique fingerprint.

  • Cite this

    Cutlip, D. E., Garratt, K. N., Novack, V., Barakat, M., Meraj, P., Maillard, L., Erglis, A., Jauhar, R., Popma, J. J., Stoler, R., Silber, S., Cutlip, D., Allaqaband, S., Caputo, R., Beohar, N., Brown, D., Garratt, K., Jauhar, R., George, J., ... Silber, S. (2017). 9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System. JACC: Cardiovascular Interventions, 10(2), 160-167. https://doi.org/10.1016/j.jcin.2016.10.037