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Design and rationale of a randomized trial of COBRA PzF stenting to REDUCE duration of triple therapy (COBRA-REDUCE)

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journal contribution
posted on 27.05.2021, 12:40 by Roisin Colleran, Michael Joner, Donald Cutlip, Philip Urban, Michael Maeng, Rajiv Jauhar, Mark Barakat, Jonathan M Michel, Roxana Mehran, Ajay J Kirtane, Luc Maillard, Adnan Kastrati, Robert Byrne, COBRA-REDUCE investigators

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.

Funding

CeloNova BioSciences Inc. San Antonio, TX, USA

History

Comments

The original article is available at https://www.sciencedirect.com

Published Citation

Colleran R, Joner M, Cutlip D, Urban P, Maeng M, Jauhar R, Barakat M, Michel JM, Mehran R, Kirtane AJ, Maillard L, Kastrati A, Byrne RA, COBRA-REDUCE investigators. Design and rationale of a randomized trial of COBRA PzF stenting to REDUCE duration of triple therapy (COBRA-REDUCE). Cardiovasc Revasc Med. 2021:S1553-8389(21)00051-8.

Publication Date

22 January 2021

PubMed ID

33608239

Department/Unit

  • School of Pharmacy and Biomolecular Sciences

Research Area

  • Vascular Biology

Publisher

Elsevier

Version

  • Published Version (Version of Record)