CeloNova BioSciences has announced that it has successfully completed enrolment into the COBRA REDUCE randomised controlled trial to evaluate the safety and efficacy of the Cobra PzF nanocoated coronary stent (NCS) in percutaneous coronary intervention (PCI) with 14-day dual antiplatelet therapy (DAPT). The study will compare it to US Food and Drug Administration (FDA)-approved drug-eluting stents (DES) with three or six months DAPT in 996 patients at high bleeding risk across 60 global sites.
A press release from CeloNova states that the Cobra PzF NCS is nanocoated with Polyzene-F, a surface coating that acts as a barrier between the device, intimal surface, and circulating elements in the blood. It has demonstrated anti-inflammatory and thromboresistant properties, and significantly faster, higher quality healing compared to market-leading DES in preclinical studies.
The statement from the company points out that COBRA REDUCE is the world’s first and only study to evaluate 14-day DAPT in high bleeding risk patients. All enrolled patients are on oral anticoagulation therapy. Many patients also share a second major or minor bleeding criteria, such as recent ischaemic stroke, cancer, anaemia, or severe or end-stage chronic kidney disease.
Robert A Byrne (Royal College of Surgeons in Ireland [RSCI] University of Health Sciences, Dublin, Ireland) is coprincipal investigator of the trial, which is being coordinated by the ISAR Research Center in Munich, Germany. He says in the press release: “The outcome of the COBRA REDUCE trial represents a potentially game-changing approach to treating high bleeding risk patients. 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.”
“The bleeding risk of a PCI patient increases considerably when you factor in major criteria such as use of oral anticoagulants, recent stroke, or undeferrable surgery post-PCI. Unfortunately, these patients and others are excluded from participating in clinical studies due to their higher risk profile,” says Carl St Bernard, president and chief executive officer of CeloNova. “COBRA REDUCE’s rigorous and randomised approach is designed to assess such ‘worst-case’ clinical bleeding scenarios and the impact of significantly fewer medications with COBRA PzF NCS compared to market-leading DES.”