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

COBRA-REDUCE investigators

Research output: Contribution to journalArticlepeer-review

7 Scopus citations

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.

Original languageEnglish
Pages (from-to)17-24
Number of pages8
JournalCardiovascular Revascularization Medicine
Volume34
DOIs
StatePublished - Jan 2022

Keywords

  • Cobra PzF
  • Coronary stenting
  • Drug-eluting stent
  • High bleeding risk
  • Oral anticoagulation
  • Percutaneous coronary intervention
  • Polymer-coated stent
  • Polyzene-F
  • Randomized
  • Short dual antiplatelet therapy

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