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).