News | Stents | July 24, 2020

CeloNova Completes Enrollment of First Randomized 14-Day DAPT Trial For a Stent

First-of-its-kind study evaluates ultra-short DAPT in PCI patients at high bleeding risk compared to drug-eluting stents

July 24, 2020 — CeloNova BioSciences Inc. announced it successfully completed enrollment of the COBRA REDUCE randomized control trial evaluating the safety and efficacy of the Cobra PzF NanoCoated Coronary Stent (NCS) with 14-day dual antiplatelet therapy (DAPT). The study compared the novel stent to FDA-approved drug-eluting stents (DES) with three to six months DAPT in 996 patients at high bleeding risk (HBR) across 60 global sites.

COBRA REDUCE is the world's first study to evaluate 14-day DAPT in HBR patients. All enrolled patients are on oral anticoagulation therapy (OAC), a major bleeding criteria, per the Academic Research Consortium for high bleeding risk (ARC-HBR), which is known to increase bleeding and subsequent complications.[1,2]  Many patients also share a second major or minor bleeding criteria, such as recent ischemic stroke, cancer, anemia, or severe or end-stage chronic kidney disease. The stent uses the vendor's Polyzene-F nanocoating technology.

"The outcome of the COBRA REDUCE trial represents a potentially game-changing approach to treating high bleeding risk patients," states Robert A. Byrne, M.D., professor of cardiovascular research at the RSCI University of Health Sciences in Dublin, Ireland and co-principal investigator of the trial, which is being coordinated by the ISAR Research Center in Munich, Germany. "Physicians are still in need of a safe and effective treatment option for their most urgent or non-compliant patients who are at high bleeding risk. Data from this study evaluating COBRA PzF NCS with 14-day DAPT will provide valuable information on treatment options for this underserved patient population."

"DAPT reduction strategies are of critical importance to the medical community," explained Roxana Mehran, M.D., professor of medicine and director of interventional cardiovascular research and clinical trials at the Zena and Michael A. Weiner Cardiovascular Institute at Mount Sinai School of Medicine. "We anxiously await the results of the COBRA REDUCE trial as it will play an important role regarding this unmet need."

COBRA PzF NCS is the first non drug-eluting, nanocoated coronary stent clinically proven to help physicians safely and effectively treat patients who may benefit from short, 1-month minimum dual antiplatelet therapy (DAPT).[3,4] 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.[5]

 

About COBRA REDUCE Randomized Clinical Trial

The COBRA REDUCE randomized control trial enrolled high bleeding risk patients undergoing coronary intervention who are receiving oral anticoagulation with a non-vitamin K oral anticoagulant (NOAC) or a vitamin antagonist. The trial is designed to assess superiority in terms of bleeding reduction (BARC ≥ 2) and non-inferiority in the composite of death, MI, stent thrombosis, and ischemic stroke in patients assigned to 14-days DAPT after stenting with Cobra PzF NCS vs 3 or 6-months of DAPT after stenting with standard FDA-approved DES.

Read more in the article New Directions and Trends in Coronary Metallic Stents.

For additional information: www.celonova.com

 

References:
1.  Faxon D, Eikelboom J, Berger P, et al. Consensus document: antithrombotic therapy in patients with atrial fibrillation undergoing coronary stenting. A North-American perspective. Thromb Haemost. 2011; 4:572-584.
2.  Genereux P, Giustino G2 Witzenbichler B, et al. Incidence, Predictors, and Impact of Post-Discharge Bleeding After Percutaneous Coronary Intervention. JACC. 2015;66:1036-45.
3.  Levine G, et al. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients with Coronary Artery Disease. Circulation. 2016;134(10):e123-55.
4.  Cutlip D, Garrat K, Novack V, et al. 9-Month Clinical and Angiographic Outcomes of the COBRA Polyzene-F NanoCoated Coronary Stent System. JACC Cardiovasc Interv. 2017;10(2):160-167.
5.  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.

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