Back to resultsStudy of Efficacy and Safety of Percutaneous Coronary Intervention to Improve Survival in Heart Failure (REVIVED-BCIS2)
Primary Purpose
Ischemic Cardiomyopathy
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Percutaneous Coronary Intervention
Drug Therapy for Heart Failure
Device Therapy for Heart Failure
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Cardiomyopathy focused on measuring Heart Failure, Ventricular Dysfunction, Ischemic Cardiomyopathy, Ischemic Heart Disease, Revascularization, Percutaneous Coronary Intervention, Randomized Control Trial, Implantable Cardioverter Defibrillator
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- 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
Sites / Locations
- Basingstoke and North Hampshire Hospital
- Royal Victoria Hospital
- Birmingham Heartlands Hospital
- Blackpool Victoria Hospital
- North Wales Cardiac Centre
- Royal Bournemouth Hospital
- Bristol Heart Institute
- University Hospital Coventry
- Dorset County Hospital
- Ninewells Hospital
- Royal Infirmary of Edinburgh
- Royal Devon and Exeter Hospital
- Golden Jubilee National Hospital
- Kettering General Hospital
- Leeds General Infirmary
- Glenfield Hospital
- Liverpool Heart and Chest Hospital
- Barts Heart Centre
- Royal Free Hospital
- Guy's and St Thomas' Hospital
- King's College Hospital
- St George's Hospital
- Manchester Royal Infirmary
- The James Cook University Hospital
- Freeman Hospital
- Royal Oldham Hospital
- Derriford Hospital
- Queen Alexandra Hospital
- Salisbury District Hospital
- Northern General Hospital
- Southampton General Hospital
- Lister Hospital
- Sunderland Royal Hospital
- Great Western Hospital
- Pinderfields Hospital
- New Cross Hospital
- Worcestershire Royal Hospital
- Worthing Hospital
- Wythenshawe Hospital
- York Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Percutaneous Coronary Intervention and Optimal Medical Therapy
Optimal Medical Therapy alone
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Left Ventricular Ejection Fraction
Left Ventricular Ejection Fraction (LVEF) on echocardiography
Quality of Life Scores
Kansas City Cardiomyopathy questionnaire (KCCQ) up to 2 years EuroQol EQ-5D-5L at 6 months and then yearly to the end of follow-up.
New York Heart Association Functional (NYHA) Class
Cardiovascular Death
Cardiovascular death over the entire duration of follow-up
All-cause death
All-cause death over the entire duration of follow-up
Hospitalization due to heart failure
Hospitalization due to heart failure over the entire duration of follow-up
Acute Myocardial Infarction
Acute myocardial infarction (MI) over the entire duration of follow-up
Appropriate Implantable Cardioverter Defibrillator Therapy
Appropriate implantable cardioverter defibrillator (ICD) therapy to 2 years
Unplanned further revascularization
Unplanned further revascularization over the entire duration of follow-up
Canadian Cardiovascular Society class
Canadian Cardiovascular Society (CCS) class up to 2 years
Brain-type Natriuretic Peptide level
Brain natriuretic peptide (BNP or NT-Pro BNP) up to 2 years
Major Bleeding
Major bleeding up to 2 years
Full Information
NCT ID
NCT01920048
First Posted
August 3, 2013
Last Updated
May 27, 2022
Sponsor
King's College London
Collaborators
National Institute for Health Research, United Kingdom, London School of Hygiene and Tropical Medicine, University of York, Guy's and St Thomas' NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT01920048
Brief Title
Study of Efficacy and Safety of Percutaneous Coronary Intervention to Improve Survival in Heart Failure
Acronym
REVIVED-BCIS2
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 28, 2013 (Actual)
Primary Completion Date
March 19, 2020 (Actual)
Study Completion Date
March 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King's College London
Collaborators
National Institute for Health Research, United Kingdom, London School of Hygiene and Tropical Medicine, University of York, Guy's and St Thomas' NHS Foundation Trust
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Cardiomyopathy
Keywords
Heart Failure, Ventricular Dysfunction, Ischemic Cardiomyopathy, Ischemic Heart Disease, Revascularization, Percutaneous Coronary Intervention, Randomized Control Trial, Implantable Cardioverter Defibrillator
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
700 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Percutaneous Coronary Intervention and Optimal Medical Therapy
Arm Type
Experimental
Arm Title
Optimal Medical Therapy alone
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Coronary Intervention
Other Intervention Name(s)
Coronary angioplasty/stents
Intervention Type
Drug
Intervention Name(s)
Drug Therapy for Heart Failure
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Device Therapy for Heart Failure
Intervention Description
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.
Primary Outcome Measure Information:
Title
All-cause death or Hospitalization for Heart Failure
Description
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
Time Frame
1 to 103 months (min follow-up duration: 24 months)
Secondary Outcome Measure Information:
Title
Left Ventricular Ejection Fraction
Description
Left Ventricular Ejection Fraction (LVEF) on echocardiography
Time Frame
6 months, 1 year
Title
Quality of Life Scores
Description
Kansas City Cardiomyopathy questionnaire (KCCQ) up to 2 years EuroQol EQ-5D-5L at 6 months and then yearly to the end of follow-up.
Time Frame
6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years
Title
New York Heart Association Functional (NYHA) Class
Time Frame
6 months, 1 year, 2 years
Title
Cardiovascular Death
Description
Cardiovascular death over the entire duration of follow-up
Time Frame
1 to 103 months (min follow-up duration: 24 months)
Title
All-cause death
Description
All-cause death over the entire duration of follow-up
Time Frame
1 to 103 months (min follow-up duration: 24 months)
Title
Hospitalization due to heart failure
Description
Hospitalization due to heart failure over the entire duration of follow-up
Time Frame
1 to 103 months (min follow-up duration: 24 months)
Title
Acute Myocardial Infarction
Description
Acute myocardial infarction (MI) over the entire duration of follow-up
Time Frame
1 to 103 months (min follow-up duration: 24 months)
Title
Appropriate Implantable Cardioverter Defibrillator Therapy
Description
Appropriate implantable cardioverter defibrillator (ICD) therapy to 2 years
Time Frame
6 months, 1 year, 2 years
Title
Unplanned further revascularization
Description
Unplanned further revascularization over the entire duration of follow-up
Time Frame
1 to 103 months (min follow-up duration: 24 months)
Title
Canadian Cardiovascular Society class
Description
Canadian Cardiovascular Society (CCS) class up to 2 years
Time Frame
6 months, 1 year, 2 years
Title
Brain-type Natriuretic Peptide level
Description
Brain natriuretic peptide (BNP or NT-Pro BNP) up to 2 years
Time Frame
6 months, 1 year, 2 years
Title
Major Bleeding
Description
Major bleeding up to 2 years
Time Frame
6 months, 1 year, 2 years
Other Pre-specified Outcome Measures:
Title
NHS Resource Use
Description
Health Economic Analysis
Time Frame
1 to 103 months (min follow-up duration: 24 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Divaka Perera, MB BChir, MA, MD, FRCP
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Basingstoke and North Hampshire Hospital
City
Basingstoke
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
Facility Name
Royal Victoria Hospital
City
Belfast
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Blackpool Victoria Hospital
City
Blackpool
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Facility Name
North Wales Cardiac Centre
City
Bodelwyddan
ZIP/Postal Code
LL18 5UJ
Country
United Kingdom
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Bristol Heart Institute
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
University Hospital Coventry
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Dorset County Hospital
City
Dorchester
ZIP/Postal Code
DT1 2JY
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Golden Jubilee National Hospital
City
Glasgow
ZIP/Postal Code
G81 4DY
Country
United Kingdom
Facility Name
Kettering General Hospital
City
Kettering
ZIP/Postal Code
NN16 8UZ
Country
United Kingdom
Facility Name
Leeds General Infirmary
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Glenfield Hospital
City
Leicester
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Facility Name
Liverpool Heart and Chest Hospital
City
Liverpool
ZIP/Postal Code
L14 3PE
Country
United Kingdom
Facility Name
Barts Heart Centre
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Guy's and St Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
St George's Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Manchester Royal Infirmary
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
The James Cook University Hospital
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Royal Oldham Hospital
City
Oldham
ZIP/Postal Code
OL1 2JH
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Queen Alexandra Hospital
City
Portsmouth
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Facility Name
Salisbury District Hospital
City
Salisbury
ZIP/Postal Code
SP2 8BJ
Country
United Kingdom
Facility Name
Northern General Hospital
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Lister Hospital
City
Stevenage
ZIP/Postal Code
SG1 4AB
Country
United Kingdom
Facility Name
Sunderland Royal Hospital
City
Sunderland
ZIP/Postal Code
SR4 7TP
Country
United Kingdom
Facility Name
Great Western Hospital
City
Swindon
ZIP/Postal Code
SN3 6BB
Country
United Kingdom
Facility Name
Pinderfields Hospital
City
Wakefield
ZIP/Postal Code
WF1 4DG
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Name
Worcestershire Royal Hospital
City
Worcester
ZIP/Postal Code
WR5 1DD
Country
United Kingdom
Facility Name
Worthing Hospital
City
Worthing
ZIP/Postal Code
BN11 2DH
Country
United Kingdom
Facility Name
Wythenshawe Hospital
City
Wythenshawe
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
York Hospital
City
York
ZIP/Postal Code
YO31 8HE
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
36027563
Citation
Perera 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.
Results Reference
derived
PubMed Identifier
29852933
Citation
Perera 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.
Results Reference
derived
Learn more about this trial
Study of Efficacy and Safety of Percutaneous Coronary Intervention to Improve Survival in Heart Failure
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