Study of Efficacy and Safety of Percutaneous Coronary Intervention to Improve Survival in Heart Failure
REVIVED-BCIS2
REVascularisation for Ischaemic VEntricular Dysfunction (REVIVED): a Randomized Comparison of Percutaneous Coronary Intervention (With Optimal Medical Therapy) Versus Optimal Medical Therapy Alone for Treatment of Heart Failure Secondary to Coronary Disease
1 other identifier
interventional
700
1 country
40
Brief Summary
This study will assess whether percutaneous coronary intervention (angioplasty of the heart arteries) can improve survival and reduce hospitalization in patients with heart failure due to coronary disease, who have been treated with the best contemporary medical therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2013
Longer than P75 for not_applicable
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2013
CompletedFirst Posted
Study publicly available on registry
August 9, 2013
CompletedStudy Start
First participant enrolled
August 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedMay 31, 2022
May 1, 2022
6.6 years
August 3, 2013
May 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-cause death or Hospitalization for Heart Failure
This composite endpoint will be collected over the entire duration of follow-up in the trial when the last patient randomized has reached 2 years of follow-up post randomization
1 to 103 months (min follow-up duration: 24 months)
Secondary Outcomes (12)
Left Ventricular Ejection Fraction
6 months, 1 year
Quality of Life Scores
6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years
New York Heart Association Functional (NYHA) Class
6 months, 1 year, 2 years
Cardiovascular Death
1 to 103 months (min follow-up duration: 24 months)
All-cause death
1 to 103 months (min follow-up duration: 24 months)
- +7 more secondary outcomes
Other Outcomes (1)
NHS Resource Use
1 to 103 months (min follow-up duration: 24 months)
Study Arms (2)
Percutaneous Coronary Intervention and Optimal Medical Therapy
EXPERIMENTALOptimal Medical Therapy alone
ACTIVE COMPARATORInterventions
The optimal combination of drugs and doses for each patient will be individualized and will be determined by his/her physician, in accordance with local and international clinical practice guidelines
The optimal device therapy for each patient will be individualized and will be determined by his/her physician, in accordance with local and international clinical practice guidelines. In most cases the device will be an Implantable Cardioverter Defibrillator and/or Cardiac Resynchronization Therapy.
Eligibility Criteria
You may qualify if:
- ALL of the following:
- Poor left ventricular function (EF≤35%)
- Extensive coronary disease
- Viability in at least 4 dysfunctional segments that can be revascularised by PCI
You may not qualify if:
- Myocardial infarction \< 4 weeks prior to randomisation (clinical definition)
- Decompensated heart failure requiring inotropic support, invasive or non-invasive ventilation or Intra-aortic Balloon Pump/left ventricular assist device therapy \<72 hours prior to randomization
- Sustained Ventricular Tachycardia/Ventricular Fibrillation or appropriate Implantable Cardioverter Defibrillator discharges \<72 hours prior to randomization
- Valve disease requiring intervention
- Contraindications to percutaneous coronary intervention
- Age \<18 yrs
- Estimated Glomerular Filtration Rate \< 25 ml/min, unless established on dialysis
- Women who are pregnant
- Previously enrolled in REVIVED-BCIS2 or current enrollment in other study that may affect REVIVED-BCIS2 outcome data
- Life expectancy \< 1 yr due to non-cardiac pathology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- King's College Londonlead
- National Institute for Health Research, United Kingdomcollaborator
- London School of Hygiene and Tropical Medicinecollaborator
- University of Yorkcollaborator
- Guy's and St Thomas' NHS Foundation Trustcollaborator
Study Sites (40)
Basingstoke and North Hampshire Hospital
Basingstoke, RG24 9NA, United Kingdom
Royal Victoria Hospital
Belfast, BT12 6BA, United Kingdom
Birmingham Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
Blackpool Victoria Hospital
Blackpool, FY3 8NR, United Kingdom
North Wales Cardiac Centre
Bodelwyddan, LL18 5UJ, United Kingdom
Royal Bournemouth Hospital
Bournemouth, BH7 7DW, United Kingdom
Bristol Heart Institute
Bristol, BS2 8HW, United Kingdom
University Hospital Coventry
Coventry, CV2 2DX, United Kingdom
Dorset County Hospital
Dorchester, DT1 2JY, United Kingdom
Ninewells Hospital
Dundee, DD1 9SY, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA, United Kingdom
Royal Devon and Exeter Hospital
Exeter, EX2 5DW, United Kingdom
Golden Jubilee National Hospital
Glasgow, G81 4DY, United Kingdom
Kettering General Hospital
Kettering, NN16 8UZ, United Kingdom
Leeds General Infirmary
Leeds, LS1 3EX, United Kingdom
Glenfield Hospital
Leicester, LE3 9QP, United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, L14 3PE, United Kingdom
Barts Heart Centre
London, EC1A 7BE, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
Guy's and St Thomas' Hospital
London, SE1 7EH, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
St George's Hospital
London, SW17 0QT, United Kingdom
Manchester Royal Infirmary
Manchester, M13 9WL, United Kingdom
The James Cook University Hospital
Middlesbrough, TS4 3BW, United Kingdom
Freeman Hospital
Newcastle, NE7 7DN, United Kingdom
Royal Oldham Hospital
Oldham, OL1 2JH, United Kingdom
Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
Queen Alexandra Hospital
Portsmouth, PO6 3LY, United Kingdom
Salisbury District Hospital
Salisbury, SP2 8BJ, United Kingdom
Northern General Hospital
Sheffield, S5 7AU, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Lister Hospital
Stevenage, SG1 4AB, United Kingdom
Sunderland Royal Hospital
Sunderland, SR4 7TP, United Kingdom
Great Western Hospital
Swindon, SN3 6BB, United Kingdom
Pinderfields Hospital
Wakefield, WF1 4DG, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Worcestershire Royal Hospital
Worcester, WR5 1DD, United Kingdom
Worthing Hospital
Worthing, BN11 2DH, United Kingdom
Wythenshawe Hospital
Wythenshawe, M23 9LT, United Kingdom
York Hospital
York, YO31 8HE, United Kingdom
Related Publications (9)
Ovesen C, Dodd M, Ryan M, Clayton T, Sharples L, Perera D. Impact of baseline risk of death or hospitalization on effectiveness of revascularization in patients with ischaemic left ventricular dysfunction-a prespecified analysis of REVIVED-BCIS2. Eur Heart J Qual Care Clin Outcomes. 2025 Dec 19;11(8):1440-1447. doi: 10.1093/ehjqcco/qcaf108.
PMID: 40972554DERIVEDEzad SM, McEntegart M, Dodd M, Didagelos M, Sidik N, Li Kam Wa M, Morgan HP, Pavlidis A, Weerackody R, Walsh SJ, Spratt JC, Strange J, Ludman P, Chiribiri A, Clayton T, Petrie MC, O'Kane P, Perera D; REVIVED-BCIS2 Investigators. Impact of Anatomical and Viability-Guided Completeness of Revascularization on Clinical Outcomes in Ischemic Cardiomyopathy. J Am Coll Cardiol. 2024 Jul 23;84(4):340-350. doi: 10.1016/j.jacc.2024.04.043. Epub 2024 May 15.
PMID: 38759904DERIVEDRyan M, Taylor D, Dodd M, Spertus JA, Kosiborod MN, Shaukat A, Docherty KF, Clayton T, Perera D, Petrie MC; REVIVED-BCIS2 Investigators. Effect of PCI on Health Status in Ischemic Left Ventricular Dysfunction: Insights From REVIVED-BCIS2. JACC Heart Fail. 2024 Sep;12(9):1553-1562. doi: 10.1016/j.jchf.2024.03.010. Epub 2024 Apr 8.
PMID: 38727649DERIVEDChivardi C, Morgan H, Sculpher MJ, Clayton T, Evans R, Dodd M, Petrie M, Rinaldi CA, O'Kane P, Brown L, Perera D, Saramago P; REVIVED-BCIS2 Investigators. Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction: Cost-Effectiveness Analysis of the REVIVED-BCIS2 Trial. Circ Cardiovasc Qual Outcomes. 2024 Jan;17(1):e010533. doi: 10.1161/CIRCOUTCOMES.123.010533. Epub 2023 Nov 6.
PMID: 37929587DERIVEDPerera D, Ryan M, Morgan HP, Greenwood JP, Petrie MC, Dodd M, Weerackody R, O'Kane PD, Masci PG, Nazir MS, Papachristidis A, Chahal N, Khattar R, Ezad SM, Kapetanakis S, Dixon LJ, De Silva K, McDiarmid AK, Marber MS, McDonagh T, McCann GP, Clayton TC, Senior R, Chiribiri A; REVIVED-BCIS2 Investigators. Viability and Outcomes With Revascularization or Medical Therapy in Ischemic Ventricular Dysfunction: A Prespecified Secondary Analysis of the REVIVED-BCIS2 Trial. JAMA Cardiol. 2023 Dec 1;8(12):1154-1161. doi: 10.1001/jamacardio.2023.3803.
PMID: 37878295DERIVEDPerera D, Morgan HP, Ryan M, Dodd M, Clayton T, O'Kane PD, Greenwood JP, Walsh SJ, Weerackody R, McDiarmid A, Amin-Youssef G, Strange J, Modi B, Lockie T, Hogrefe K, Ahmed FZ, Behan M, Jenkins N, Abdelaal E, Anderson M, Watkins S, Evans R, Rinaldi CA, Petrie MC; REVIVED-BCIS2 Investigators. Arrhythmia and Death Following Percutaneous Revascularization in Ischemic Left Ventricular Dysfunction: Prespecified Analyses From the REVIVED-BCIS2 Trial. Circulation. 2023 Sep 12;148(11):862-871. doi: 10.1161/CIRCULATIONAHA.123.065300. Epub 2023 Aug 9.
PMID: 37555345DERIVEDEzad SM, Ryan M, Perera D. Can Percutaneous Coronary Intervention Revive a Failing Heart? Heart Int. 2022 Dec 21;16(2):72-74. doi: 10.17925/HI.2022.16.2.72. eCollection 2022.
PMID: 36741102DERIVEDPerera D, Clayton T, O'Kane PD, Greenwood JP, Weerackody R, Ryan M, Morgan HP, Dodd M, Evans R, Canter R, Arnold S, Dixon LJ, Edwards RJ, De Silva K, Spratt JC, Conway D, Cotton J, McEntegart M, Chiribiri A, Saramago P, Gershlick A, Shah AM, Clark AL, Petrie MC; REVIVED-BCIS2 Investigators. Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction. N Engl J Med. 2022 Oct 13;387(15):1351-1360. doi: 10.1056/NEJMoa2206606. Epub 2022 Aug 27.
PMID: 36027563DERIVEDPerera D, Clayton T, Petrie MC, Greenwood JP, O'Kane PD, Evans R, Sculpher M, Mcdonagh T, Gershlick A, de Belder M, Redwood S, Carr-White G, Marber M; REVIVED investigators. Percutaneous Revascularization for Ischemic Ventricular Dysfunction: Rationale and Design of the REVIVED-BCIS2 Trial: Percutaneous Coronary Intervention for Ischemic Cardiomyopathy. JACC Heart Fail. 2018 Jun;6(6):517-526. doi: 10.1016/j.jchf.2018.01.024.
PMID: 29852933DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Divaka Perera, MB BChir, MA, MD, FRCP
King's College London
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Cardiologist and Professor of Cardiology
Study Record Dates
First Submitted
August 3, 2013
First Posted
August 9, 2013
Study Start
August 28, 2013
Primary Completion
March 19, 2020
Study Completion
March 31, 2022
Last Updated
May 31, 2022
Record last verified: 2022-05