Author + information
- Received August 19, 2016
- Revision received October 27, 2016
- Accepted October 28, 2016
- Published online January 16, 2017.
- Donald E. Cutlip, MDa,∗ (, )
- Kirk N. Garratt, MDb,
- Victor Novack, MD, PhDc,
- Mark Barakat, MDd,
- Perwaiz Meraj, MDe,
- Luc Maillard, MD, PhDf,
- Andrejs Erglis, MDg,
- Rajiv Jauhar, MDe,
- Jeffrey J. Popma, MDa,
- Robert Stoler, MDh,
- Sigmund Silber, MDi,
- PzF SHIELD Trial Investigators
- aCardiology Division, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts
- bChristiana Health Care System, Newark, Delaware
- cClinical Research Center, Soroka University Medical Center, Beersheba, Israel
- dNorth Shore University Hospital, Manhasset, New York
- eGCS ES Axium Rambot, Aix-en-Provence, France
- fUniversity of Latvia, Riga, Latvia
- gBaylor Heart and Vascular Hospital at Baylor University Medical Center, Dallas, Texas
- hDepartment of Cardiology, Heart Center at the Isar, Munich, Germany
- iCeloNova BioSciences, San Antonio, Texas
- ↵∗Reprint requests and correspondence:
Dr. Donald E. Cutlip, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, Massachusetts 02215.
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.
Dr. Cutlip has received contracted research support from Boston Scientific, Medtronic, and CeloNova BioSciences. Dr. Garratt has received consulting fees from CeloNova BioSciences. Dr. Barakat is an employee of CeloNova BioSciences. Dr. Maillard has received consulting fees from CeloNova BioSciences. Dr. Popma has received institutional grants from Medtronic, Boston Scientific, Abbott Vascular, Direct Flow Medical, and Terumo; serves on the medical advisory board for Boston Scientific; has received consulting fees from Direct Flow Medical; and has equity interest in Direct Flow Medical. Dr. Stoler is a consultant and advisory board member for Boston Scientific and Medtronic. Dr. Silber has received an institutional research grant from CeloNova BioSciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received August 19, 2016.
- Revision received October 27, 2016.
- Accepted October 28, 2016.
- American College of Cardiology Foundation