Design and Rationale of a Randomized Trial of COBRA PzF Stenting to REDUCE Duration of Triple Therapy (COBRA-REDUCE).

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.

Informations de copyright

Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of competing interest Dr Colleran reports speakers fees from Medtronic. Dr Joner reports personal fees from Biotronik, personal fees from Orbus Neich, grants and personal fees from Boston Scientific, grants and personal fees from Edwards, personal fees from Astra Zeneca, personal fees from Recor, grants from Amgen outside the submitted work. Dr Urban reports honoraria for CEC and DSMB activities from Edwards Lifesciences and Cardialysis, is a consultant for Biosensors and is a shareholder of CERC (Massy, France) and of MedAlliance (Morges, Switzerland). Dr Maeng has received lecture or advisory board fees from Astra-Zeneca, Bayer, Boehringer-Ingelheim, Boston Scientific, Bristol-Myers Squibb, and Novo Nordisk; and has received a research grant from Bayer. Dr Barakat is an employee of Celonova Biosciences Inc. Dr Mehran reports consultant fees to the institution from Abbott Laboratories and Spectranetics/Philips/Valcano Corp; consulting fees from Boston Scientific, Cardiovascular Systems Inc., Medscape, Siemens Medical Solutions, Regeneron Pharmaceuticals Inc., Roivant Sciences Inc., and Sanofi; being the spouse of a consultant for Abiomed and The Medicines Company; research funding to the institution from AstraZeneca, Bayer, Beth Israel Deaconess Hospital, BMS, CSL Behring, Eli Lilly and DSI, Medtronic, Novartis Pharmaceuticals, and Orbus Neich; scientific advisory board fees from PLx Opco Inc., dba PLx Pharma Inc.; scientific advisory board fees to the institution from Bristol-Myers Squibb; executive committee fees from Janssen Pharmaceuticals and Osprey Medical; speaker engagements for Abbott Laboratories; equity from Claret Medical and Elixir Medical; and Data Safety Monitoring Board fees to the institution from Atermark Research Partners. Dr. Kirtane reports institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical. In addition to research grants, institutional funding includes fees paid to Columbia University and/or Cardiovascular Research Foundation for speaking engagements and/or consulting; no speaking/consulting fees were personally received; personal fees received consist of travel expenses/meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, CSI, CathWorks, Siemens, Philips, ReCor Medical, Chiesi, OpSens, Zoll, and Regeneron. Dr. Byrne reports research funding to the institution of prior employment from Celonova Biosciences and research or educational funding to the institution of current employment from Abbott Vascular, Biosensors, Biotronik and Boston Scientific. The other authors report no conflicts of interest.