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%.
Photo -
https://mma.prnewswire.com/media/1174659/COBRA_PzF_NanoCoated_Coronary_Stent.jpg