CeloNova recently announced positive interim results from its randomized trial of Cobra PzF stenting to reduce the duration of triple therapy.
The randomized, global 14-day dual anti-platelet therapy study of high bleeding risk (HBR) patients enrolled 996 HBR participants across 59 enrolling global sites. Each patient received either the Cobra PzF NCF with 14-day dual antiplatelet therapy (DAPT) or an FDA-approved DES with 3 or 6 months DAPT.
“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,” Robert Byrne, chair of cardiovascular research at the Royal College of Surgeons and principal investigator in the Cobra Reduce trial, said in a news release. “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.”
In the trial, 100% of enrolled patients are on oral anticoagulation therapy (OAC) with over 90% of patients presenting with atrial fibrillation. About half of the patients had a second or third major or minor ARC-HBR bleeding criteria like ischemic stroke, cancer, anemia or severe or end-stage chronic kidney disease.
Significantly fewer patients in the Cobra PzF NCS arm received a reduction in OAC intensity compared to the DES group. Both groups presented with highly complex lesions and the Cobra PzF NCS arm presented with statistically higher bifurcation rates.
Interim results also demonstrated 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 in both groups; low initial ischemic-drive TLR at 6 months.
“We are pleased with COBRA PzF NCS’ preliminary performance with just 14-days DAPT in aspects of bleeding and ischemic events,” president and CEO Carl St. Bernard said. “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,” Roxana Mehran, a member of the Cobra Reduce Steering Committee, said. “We hope to gain further insight into its efficacy with 14-days DAPT in the secondary analysis at 12 months.”
CeloNova anticipates final co-primary endpoint analysis and secondary endpoints at 12 months to be revealed in Q2 of 2021.
