CeloNova Announces Late-Breaking Evidence from First-Ever Randomized Controlled Trial Evaluating 14-Days DAPT in Complex Patients at High Bleeding Risk Following PCI - Seite 2

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