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