Percutaneous revascularization for ischemic ventricular dysfunction: rationale and design of the REVIVED-BCIS2 trial: percutaneous coronary intervention for ischemic cardiomyopathy

Perera, D. et al. (2018) Percutaneous revascularization for ischemic ventricular dysfunction: rationale and design of the REVIVED-BCIS2 trial: percutaneous coronary intervention for ischemic cardiomyopathy. JACC: Heart Failure, 6(6), pp. 517-526. (doi: 10.1016/j.jchf.2018.01.024) (PMID:29852933)

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).

• Item Type: Articles
• Keywords: Heart failure, ischemic cardiomyopathy, left ventricular dysfunction, myocardial viability, percutaneous coronary intervention.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Petrie, Professor Mark
• Authors: Perera, D., Clayton, T., Petrie, M. C., Greenwood, J. P., O'Kane, P. D., Evans, R., Sculpher, M., Mcdonagh, T., Gershlick, A., de Belder, M., Redwood, S., Carr-White, G., and Marber, M.
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
• Journal Name: JACC: Heart Failure
• Publisher: Elsevier Inc.
• ISSN: 2213-1779
• ISSN (Online): 2213-1787
• Published Online: 28 May 2018
• Copyright Holders: Copyright © 2018 American College of Cardiology Foundation
• First Published: First published in JACC: Heart Failure 6(6): 517-526
• Publisher Policy: Reproduced in accordance with the publisher copyright policy