Author + information
- Divaka Perera, MA, MDa,∗ (, )
- Tim Clayton, MScb,
- Mark C. Petrie, MBChB, MDc,
- John P. Greenwood, MBChB, PhDd,
- Peter D. O’Kane, MBBS, MDe,
- Richard Evans, BAb,
- Mark Sculpher, MA, PhDf,
- Theresa Mcdonagh, MBBS, MDg,
- Anthony Gershlick, MBBSh,
- Mark de Belder, MA, MDi,
- Simon Redwood, MBBS, MDa,
- Gerald Carr-White, MBBS, PhDa,
- Michael Marber, MBBS, PhDa,
- on behalf of the REVIVED investigators
- aNational Institute for Health Research Biomedical Research Centre and British Heart Foundation Centre of Excellence, School of Cardiovascular Medicine and Sciences, King’s College London, London, United Kingdom
- bClinical Trials Unit, London School of Hygiene and Tropical Medicine, London, United Kingdom
- cInstitute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom
- dLeeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, United Kingdom
- eRoyal Bournemouth and Christchurch Hospital, United Kingdom
- fCentre for Health Economics, University of York, United Kingdom
- gKing’s College Hospital, London, United Kingdom
- hBiomedical Research Unit, University Hospitals of Leicester, Leicester, United Kingdom
- iThe James Cook Hospital, Middlesbrough, United Kingdom
- ↵∗Address for correspondence:
Prof. Divaka Perera, Cardiovascular Division, Rayne Institute, 4th Floor Lambeth Wing, St Thomas’ Hospital, Westminster Bridge Road, London SE1 7EH, United Kingdom.
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)
- heart failure
- ischemic cardiomyopathy
- left ventricular dysfunction
- myocardial viability
- percutaneous coronary intervention
The trial is sponsored by King’s College London, UK; and funded by the UK Department of Health via the National Institute for Health Research (NIHR) (Health Technology Assessment project 10/57/67). The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received December 30, 2017.
- Accepted January 23, 2018.
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