CeloNova Announces Late-Breaking Evidence from First-Ever Randomized Controlled Trial Evaluating 14-Days DAPT in Complex Patients at High Bleeding Risk Following PCI

The novel non-DES, non-BMS COBRA PzF NanoCoated Coronary Stent (NCS) with just 14-days DAPT demonstrated statistically less bleeding (BARC 1-5) compared to the DES arm at 3 or 6 months DAPT post-PCI, low 0.6% ST and low 3.7% ischemic-driven TLR at 6 months.

SAN ANTONIO, Oct. 18, 2020 /PRNewswire/ -- CeloNova BioSciences, Inc. (CeloNova), a global medical device company that offers a family of innovative products based upon its proprietary Polyzene™-F nanocoating technology, today announced interim results from the Randomized Trial of COBRA PzF Stenting to REDUCE Duration of Triple Therapy (COBRA-REDUCE), the world's first and only randomized, global 14-day dual antiplatelet therapy (DAPT) study of high bleeding risk patients (HBR), during a late-breaking clinical science session at TCT Connect.

"Today marks a very significant milestone in providing valuable clinical insights into the DAPT duration and stent choice for high bleeding risk patients formally excluded from clinical trials," stated Professor Robert Byrne, MB, BCh, PhD, MRCPI, FESC, Director of Cardiology, Mater Private Hospital, Dublin, Chair of Cardiovascular Research at the Royal College of Surgeons and a Principal Investigator in the COBRA REDUCE trial.

"I would like to thank my colleagues for their outstanding support in successfully completing this portion of the study despite challenges brought on by the COVID-19 world pandemic. We look forward to concluding patient follow-up and secondary analysis at 12 months," said Byrne.

In the COBRA REDUCE trial, 100% of enrolled patients were on oral anticoagulation therapy (OAC) with over 90% of patients presenting with atrial fibrillation. OAC is a major bleeding criterion, per the Academic Research Consortium for High Bleeding Risk (ARC-HBR). Furthermore, close to half of all patients in the study share a second or third major or minor ARC-HBR bleeding criteria, such as recent ischemic stroke, cancer, anemia, or severe or end-stage chronic kidney disease. It was noted that significantly less patients in the COBRA PzF NCS arm received a reduction in OAC intensity compared to the DES arm (COBRA: 46% vs. DES: 56%; p=0.006). Both study arms presented with highly complex lesions and the COBRA PzF NCS arm presented with statistically higher bifurcation rates (COBRA: 20% vs DES: 15%; p=0.034).

The COBRA REDUCE study randomized 996 HBR patients across 59 enrolling global sites to receive either COBRA PzF NCS (n=495) with 14-day DAPT or an FDA-approved DES (n=501) with 3 or 6 months DAPT. COBRA PzF NCS demonstrated the following interim results:

• Numerically less bleeding in the co-primary endpoint of BARC class ≥2 bleeding after 14 days (COBRA: 7.5% vs DES: 8.9%; p=0.477) and statistically less bleeding over DES in BARC class 1-5 after randomization (COBRA: 13% vs. DES: 18.3%; p=0.026).
• Numerically similar rates in the composite co-primary endpoint of ischemic safety compared to the DES arm (COBRA: 7.7% vs DES: 5.2%; p=0.061). Additional analysis showed statistical non-inferiority when the composite endpoint includes only cardiac-related mortality.
• Equal low probable and definite stent thrombosis (0.6%) in both groups (not powered).
• Low initial ischemic-driven TLR at 6 months (3.7%).

"We are pleased with COBRA PzF NCS' preliminary performance with just 14-days DAPT in aspects of bleeding and ischemic events," said Carl St. Bernard, President and Chief Executive Officer of CeloNova. "Finding the right DAPT balance is critical to reducing the complexity and complications of long-DAPT regimens following stent placement. The COBRA REDUCE study has advanced our understanding of how to best strike this balance."

"It is encouraging to see that the COBRA stent demonstrated a very low stent thrombosis rate with just 14-days DAPT in this high-risk patient population," said Roxana Mehran, MD, professor of Medicine and Director of Interventional Cardiovascular Research and Clinical Trials at the Zena and Michael A. Wiener Cardiovascular Institute at Icahn School of Medicine at Mount Sinai and a member of the COBRA REDUCE Steering Committee. "We hope to gain further insight into its efficacy with 14-days DAPT in the secondary analysis at 12 months."

COBRA REDUCE's final co-primary endpoint analysis and secondary endpoints, including composite of all-cause death, cardiac death, MI, ischemia-driven TLR, definite and probable stent thrombosis and ischemic stroke at 12-months, are expected to be revealed in Q2 of 2021.

About COBRA PzF NanoCoated Coronary Stent (NCS)

COBRA PzF NCS is the first non drug-eluting, nanocoated coronary stent. COBRA PzF NCS is nanocoated with Polyzene-F, a revolutionary surface coating that acts as a barrier between the device, intimal surface and circulating elements in the blood. It has demonstrated anti-inflammatory and thrombo-resistant properties and significantly faster, higher quality healing compared to market-leading DES in preclinical studies.^†1

Over 25,000 patients worldwide have been treated to date with COBRA PzF NCS. The novel stent has been extensively evaluated over the course of 10 years and 10 clinical trials in roughly 3,300 patients worldwide, consistently demonstrating excellent results with low TLR and low ST with short DAPT regimens in a real-world patient population.²

About CeloNova BioSciences, Inc.

CeloNova BioSciences, Inc. is a global medical device company that develops, manufactures and markets a family of products based upon its novel Polyzene-F nanocoating technology. The next generation nanocoating is the result of years of rigorous scientific research and engineering and has been extensively published in numerous academic articles to date. For additional information about CeloNova, please visit our website at www.celonova.com.

The COBRA PzF NanoCoated Coronary Stent System is indicated for improving coronary luminal diameter in patients, including patients with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions in native coronary arteries. The COBRA PzF NanoCoated stent is intended for use in patients eligible for percutaneous transluminal coronary angioplasty (PTCA) with reference vessel diameter (RVD) of 2.5-4.0mm and lesion length of ≤24mm. Click here for IMPORTANT SAFETY INFORMATION. Rx only. 

The COBRA PzF NanoCoated Coronary Stent is not currently approved or indicated for high bleeding risk patients with 14-day DAPT.

*myocardial infarction, definite and probable stent thrombosis, or ischemic stroke
† AS DEMONSTRATED IN PRECLINICAL STUDIES. Correlation between bench testing, animal studies and humans have not been determined.

1. Jinnouchi H Mori H, et al. Thromboresistance and Functional Healing in the COBRA PzF Stent versus Competitor DES: Implications for Dual Anti-Platelet Therapy. EuroIntervention. 2019 July 20;15(4):e342-e353. 2. ATLANTA FIM (n=55) TLR 3.6%, LST 0%; ATLANTA 2 Registry (n=300) TLR 6.5%, LST 0%; REVEAL OCT (n=34) Strut Coverage: PzF-97%, DES-90%, BMS-96%; ATLANTA FME Registry (n=500) TLR 4.3%, LST 0%; MAILLARD IIT (n=100) TLR 5%, ST 0%; UMEÅ IIT (n=103) TLR 3.9%, ST 0%.

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