Percutaneous Revascularization for Ischemic Ventricular Dysfunction: Rationale and Design of the REVIVED-BCIS2 Trial : Percutaneous Coronary Intervention for Ischemic Cardiomyopathy

Divaka Perera, Tim Clayton, Mark C. Petrie, John P. Greenwood, Peter D. O’Kane, Richard Evans, Mark Sculpher, Theresa Mcdonagh, Anthony Gershlick, Mark de Belder, Simon Redwood, Gerald Carr-White, Michael Marber

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74 Citations (Scopus)
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Abstract

Objectives
Evaluate whether PCI in combination with optimal medical therapy (OMT) will reduce all-cause death and hospitalization for HF compared to a strategy of OMT alone.

Background
Ischemic cardiomyopathy (ICM) is the most common cause of heart failure (HF) and is associated with significant mortality and morbidity. Surgical revascularization has been shown to improve long-term outcomes in some patients, but surgery itself carries a major early hazard. Percutaneous coronary intervention (PCI) may allow a better balance between risk and benefit.

Methods
REVIVED-BCIS2 is a prospective, multi-center, open-label, randomized controlled trial, funded by the National Institute for Health Research in the United Kingdom. Follow-up will be for at least 2 years from randomization. Secondary outcomes include left ventricular ejection fraction (LVEF), quality of life scores, appropriate implantable cardioverter defibrillator therapy and acute myocardial infarction. Patients with LVEF ≤35%, extensive coronary disease and demonstrable myocardial viability are eligible for inclusion and those with a myocardial infarction within 4 weeks, decompensated HF or sustained ventricular arrhythmias within 72 h are excluded. A trial of 700 patients has more than 85% power to detect a 30% relative reduction in hazard.

Results
A total of 400 patients have been enrolled to date.

Conclusions
International guidelines do not provide firm recommendations on the role of PCI in managing severe ICM, because of a lack of robust evidence. REVIVED-BCIS2 will provide the first randomized data on the efficacy and safety of PCI in ICM and has the potential to inform guidelines pertaining to both revascularization and HF. (Study of Efficacy and Safety of Percutaneous Coronary Intervention to Improve Survival in Heart Failure [REVIVED-BCIS2]; NCT01920048) (REVascularisation for Ischaemic VEntricular Dysfunction; ISRCTN45979711)
Original languageEnglish
Pages (from-to)517-526
Number of pages10
JournalJACC: Heart Failure
Volume6
Issue number6
Early online date28 May 2018
DOIs
Publication statusPublished - Jun 2018

Keywords

  • heart failure
  • ischemic cardiomyopathy
  • left ventricular dysfunction
  • myocardial viability
  • percutaneous coronary intervention

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