Róisín Colleran1, Michael Joner2, Donald Cutlip3, Philip Urban4, Michael Maeng5, Rajiv Jauhar6, Mark Barakat7, Jonathan M Michel1, Roxana Mehran8, Ajay J Kirtane9, Luc Maillard10, Adnan Kastrati11, Robert A Byrne12. 1. Deutsches Herzzentrum München, Technische Universität München, Munich, Germany. 2. Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; German Centre for Cardiovascular Research (DZHK), partner site Munich Heart Alliance, Munich, Germany. 3. Cardiology Division, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States of America. 4. La Tour Hospital, Geneva, Switzerland; CERC (Cardiovascular European Research Center), Massy, France. 5. Aarhus University Hospital, Aarhus, Denmark. 6. North Shore University Hospital, Manhasset New York, NY, USA. 7. Celonova Biosciences Inc., San Antonio, TX, USA. 8. Icahn School of Medicine at Mount Sinai, New York, NY, United States of America. 9. Department of Medicine, Columbia University Irving Medical Center/New York Presbyterian Hospital, New York, NY, United States of America; Cardiovascular Research Foundation, New York, NY, United States of America. 10. GCS-ES Axium-Rambot, Clinique Axium, Aix en Provence, France. 11. Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; German Centre for Cardiovascular Research (DZHK), partner site Munich Heart Alliance, Munich, Germany. Electronic address: kastrati@dhm.mhn.de. 12. Cardiovascular Research Institute Dublin, Mater Private Hospital, Dublin, Ireland; School of Pharmacy and Biomolecular Sciences, Royal College of Surgeons University of Medicine and Health Sciences, Dublin, Ireland. Electronic address: robert.byrne@materprivate.ie.
Abstract
BACKGROUND/ PURPOSE: A coronary stent with thromboresistant and pro-healing properties such as the polymer polyzene F-coated (COBRA PzF) stent might safely allow for a very short duration of triple therapy in patients taking oral anticoagulation (OAC) who undergo coronary stenting. METHODS: The COBRA-REDUCE trial is a prospective, multinational, randomized, open-label, assessor-blinded trial. A total of 996 patients at high bleeding risk because of requirement for OAC (with a vitamin K antagonist or non-vitamin K antagonist for any indication) will be randomized at sites in the United States and Europe to treatment with the COBRA-PzF stent followed by very short duration (14 days) DAPT or a Food and Drug Administration (FDA)-approved new generation drug-eluting stent followed by guideline-recommended DAPT duration (3 or 6 months). Two co-primary endpoints will be tested at 6 months: a bleeding co-primary endpoint (bleeding academic research consortium [BARC] ≥2 bleeding beyond 14 days or after hospital discharge, whichever is later [superiority hypothesis]) and a thrombo-embolic co-primary endpoint (the composite of all-cause death, myocardial infarction, definite/probable stent thrombosis or ischaemic stroke [non-inferiority hypothesis]). The trial is registered at clinicaltrials.gov (NCT02594501). CONCLUSION: The COBRA-REDUCE trial will determine whether coronary stenting with the COBRA PzF stent followed by 14 days of clopidogrel will reduce bleeding without increasing thrombo-embolic events compared with FDA-approved DES followed by 3-6 months clopidogrel in patients taking OAC and aspirin.
BACKGROUND/ PURPOSE: A coronary stent with thromboresistant and pro-healing properties such as the polymer polyzene F-coated (COBRA PzF) stent might safely allow for a very short duration of triple therapy in patients taking oral anticoagulation (OAC) who undergo coronary stenting. METHODS: The COBRA-REDUCE trial is a prospective, multinational, randomized, open-label, assessor-blinded trial. A total of 996 patients at high bleeding risk because of requirement for OAC (with a vitamin K antagonist or non-vitamin K antagonist for any indication) will be randomized at sites in the United States and Europe to treatment with the COBRA-PzF stent followed by very short duration (14 days) DAPT or a Food and Drug Administration (FDA)-approved new generation drug-eluting stent followed by guideline-recommended DAPT duration (3 or 6 months). Two co-primary endpoints will be tested at 6 months: a bleeding co-primary endpoint (bleeding academic research consortium [BARC] ≥2 bleeding beyond 14 days or after hospital discharge, whichever is later [superiority hypothesis]) and a thrombo-embolic co-primary endpoint (the composite of all-cause death, myocardial infarction, definite/probable stent thrombosis or ischaemic stroke [non-inferiority hypothesis]). The trial is registered at clinicaltrials.gov (NCT02594501). CONCLUSION: The COBRA-REDUCE trial will determine whether coronary stenting with the COBRA PzF stent followed by 14 days of clopidogrel will reduce bleeding without increasing thrombo-embolic events compared with FDA-approved DES followed by 3-6 months clopidogrel in patients taking OAC and aspirin.