One-Year Safety and Efficacy Data Presented for CeloNova's Cobra PzF NCS Stent
May 23, 2018—CeloNova BioSciences, Inc. announced 1-year clinical trial results from the eCOBRA postmarket study of the company's Cobra polyzene-F (PzF) nanocoated coronary stent (NCS) system. The data were presented at EuroPCR 2018, held May 21–25 in Paris, France.
The clinical trial results demonstrated 4.3% target lesion revascularization, 0.3% late stent thrombosis, and 8.6% major adverse cardiovascular events in patients at high risk for bleeding and thrombosis. The patients' average age was 76 years. Approximately 30% of patients studied were on oral anticoagulant therapy, and 48% had ST-elevation myocardial infarction (STEMI) or non-STEMI at clinical presentation.
Luc Maillard, MD, the Principal Investigator for the eCOBRA trial, commented in the company's announcement, "The data from this trial provides further evidence that Cobra PzF NCS is a safe and effective treatment, particularly in complex patients with heart disease. Being able to provide an effective therapy that meets the needs of patients who are at higher risk of bleeding is of great clinical value." Dr. Maillard is Director of the Department of Cardiology at Clinique Axium in Aix-en-Provence, France.
According to CeloNova, eCOBRA is a prospective, consecutively enrolled, observational, multicenter, all-comers study composed of 1,026 patients across 17 centers, including patients with stable angina and acute coronary syndrome. The study is designed to evaluate the safety and effectiveness of Cobra PzF NCS in patients undergoing treatment of de novo coronary lesions where a drug-eluting stent (DES) is typically not indicated.
The company advised that the Cobra PzF NCS's safety and efficacy will be further explored in the COBRA-REDUCE randomized controlled trial assessing ultrashort 14-day dual antiplatelet therapy (DAPT) after percutaneous coronary intervention as compared with a US Food and Drug Administration–approved DES with 3 or 6 months of DAPT in patients on an oral anticoagulant.