The US FDA has approved the expansion of CeloNova’s ongoing clinical trial of its proprietary Cobra PzF nano-coated stent to enable the use of 14-day dual antiplatelet therapy (DAPT) in complex patients (eg. high bleeding risk). The COBRA REDUCE trial is first and only randomised control trial to assess 14-day DAPT after percutaneous coronary intervention (PCI).
The COBRA REDUCE trial is evaluating whether Cobra Pzf device, with its ultra-pure, ultra-thin Polyzene-F fluoropolymer, can optimise clinical outcomes with 14-day DAPT as compared to FDA-approved drug eluting stents with three or six-months of DAPT. The COBRA REDUCE trial will enrol up to 996 patients across 60 centres in the USA and Europe. Clinical data from CeloNova’s previous trial, known as the PzF SHIELD study, demonstrated that the Cobra stent supports very low risk for late ischaemic events and low risk for clinically driven target lesion revascularisation with a short, one-month DAPT minimum.
Robert Byrne (German Heart Center, Munich, Germany), co-lead investigator of the COBRA REDUCE trial, says: “High bleeding risk patients currently have limited stent treatment options available to them primarily due to the duration of DAPT required. The COBRA REDUCE trial aims to provide clinical insights into optimal stent selection and eliminate the compromise between the risk of bleeding or stent thrombosis.”
“The highly-anticipated COBRA REDUCE trial aims to expand upon the SHIELD study’s exceptional clinical results and demonstrate Cobra PzF stent as a safe and effective stent option when combined with 14-days of DAPT. I have many patients at high risk of bleeding or who have difficulty maintaining even short-term DAPT regimens. Being able to provide a therapy that is personalised to the patient is of great clinical value,” says Donald Cutlip, executive director of the Baim Institute for Clinical Research (formerly Harvard Research Institute).
COBRA PzF NCS and the COBRA REDUCE trial will be featured in several sessions at next week’s Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October–2 November, Denver, USA).