Study of Efficacy and Safety of Percutaneous Coronary Intervention to Improve Survival in Heart Failure (REVIVED-BCIS2)

May 27, 2022 updated by: Divaka Perera, King's College London

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Basingstoke, United Kingdom, RG24 9NA
        • Basingstoke and North Hampshire Hospital
      • Belfast, United Kingdom, BT12 6BA
        • Royal Victoria Hospital
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
      • Blackpool, United Kingdom, FY3 8NR
        • Blackpool Victoria Hospital
      • Bodelwyddan, United Kingdom, LL18 5UJ
        • North Wales Cardiac Centre
      • Bournemouth, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital
      • Bristol, United Kingdom, BS2 8HW
        • Bristol Heart Institute
      • Coventry, United Kingdom, CV2 2DX
        • University Hospital Coventry
      • Dorchester, United Kingdom, DT1 2JY
        • Dorset County Hospital
      • Dundee, United Kingdom, DD1 9SY
        • Ninewells Hospital
      • Edinburgh, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh
      • Exeter, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital
      • Glasgow, United Kingdom, G81 4DY
        • Golden Jubilee National Hospital
      • Kettering, United Kingdom, NN16 8UZ
        • Kettering General Hospital
      • Leeds, United Kingdom, LS1 3EX
        • Leeds General Infirmary
      • Leicester, United Kingdom, LE3 9QP
        • Glenfield Hospital
      • Liverpool, United Kingdom, L14 3PE
        • Liverpool Heart and Chest Hospital
      • London, United Kingdom, SE5 9RS
        • King's College Hospital
      • London, United Kingdom, Nw3 2QG
        • Royal Free Hospital
      • London, United Kingdom, SW17 0QT
        • St George's Hospital
      • London, United Kingdom, SE1 7EH
        • Guy's and St Thomas' Hospital
      • London, United Kingdom, EC1A 7BE
        • Barts Heart Centre
      • Manchester, United Kingdom, M13 9WL
        • Manchester Royal Infirmary
      • Middlesbrough, United Kingdom, TS4 3BW
        • The James Cook University Hospital
      • Newcastle, United Kingdom, NE7 7DN
        • Freeman Hospital
      • Oldham, United Kingdom, OL1 2JH
        • Royal Oldham Hospital
      • Plymouth, United Kingdom, PL6 8DH
        • Derriford Hospital
      • Portsmouth, United Kingdom, PO6 3LY
        • Queen Alexandra Hospital
      • Salisbury, United Kingdom, SP2 8BJ
        • Salisbury District Hospital
      • Sheffield, United Kingdom, S5 7AU
        • Northern General Hospital
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital
      • Stevenage, United Kingdom, SG1 4AB
        • Lister Hospital
      • Sunderland, United Kingdom, SR4 7TP
        • Sunderland Royal Hospital
      • Swindon, United Kingdom, SN3 6BB
        • Great Western Hospital
      • Wakefield, United Kingdom, WF1 4DG
        • Pinderfields Hospital
      • Wolverhampton, United Kingdom, WV10 0QP
        • New Cross Hospital
      • Worcester, United Kingdom, WR5 1DD
        • Worcestershire Royal Hospital
      • Worthing, United Kingdom, BN11 2DH
        • Worthing Hospital
      • Wythenshawe, United Kingdom, M23 9LT
        • Wythenshawe Hospital
      • York, United Kingdom, YO31 8HE
        • York Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

ALL of the following:

  1. Poor left ventricular function (EF≤35%)
  2. Extensive coronary disease
  3. Viability in at least 4 dysfunctional segments that can be revascularised by PCI

Exclusion Criteria:

  1. Myocardial infarction < 4 weeks prior to randomisation (clinical definition)
  2. 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
  3. Sustained Ventricular Tachycardia/Ventricular Fibrillation or appropriate Implantable Cardioverter Defibrillator discharges <72 hours prior to randomization
  4. Valve disease requiring intervention
  5. Contraindications to percutaneous coronary intervention
  6. Age <18 yrs
  7. Estimated Glomerular Filtration Rate < 25 ml/min, unless established on dialysis
  8. Women who are pregnant
  9. Previously enrolled in REVIVED-BCIS2 or current enrollment in other study that may affect REVIVED-BCIS2 outcome data
  10. Life expectancy < 1 yr due to non-cardiac pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Percutaneous Coronary Intervention and Optimal Medical Therapy
Procedure: Percutaneous Coronary Intervention
Other Names:
  • Coronary angioplasty/stents
Drug: Drug Therapy for Heart Failure
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
Device: Device Therapy for Heart Failure
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.
Active Comparator: Optimal Medical Therapy alone
Drug: Drug Therapy for Heart Failure
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
Device: Device Therapy for Heart Failure
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause death or Hospitalization for Heart Failure
Time Frame: 1 to 103 months (min follow-up duration: 24 months)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left Ventricular Ejection Fraction
Time Frame: 6 months, 1 year
Left Ventricular Ejection Fraction (LVEF) on echocardiography
6 months, 1 year
Quality of Life Scores
Time Frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years
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.
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
Time Frame: 6 months, 1 year, 2 years
6 months, 1 year, 2 years
Cardiovascular Death
Time Frame: 1 to 103 months (min follow-up duration: 24 months)
Cardiovascular death over the entire duration of follow-up
1 to 103 months (min follow-up duration: 24 months)
All-cause death
Time Frame: 1 to 103 months (min follow-up duration: 24 months)
All-cause death over the entire duration of follow-up
1 to 103 months (min follow-up duration: 24 months)
Hospitalization due to heart failure
Time Frame: 1 to 103 months (min follow-up duration: 24 months)
Hospitalization due to heart failure over the entire duration of follow-up
1 to 103 months (min follow-up duration: 24 months)
Acute Myocardial Infarction
Time Frame: 1 to 103 months (min follow-up duration: 24 months)
Acute myocardial infarction (MI) over the entire duration of follow-up
1 to 103 months (min follow-up duration: 24 months)
Appropriate Implantable Cardioverter Defibrillator Therapy
Time Frame: 6 months, 1 year, 2 years
Appropriate implantable cardioverter defibrillator (ICD) therapy to 2 years
6 months, 1 year, 2 years
Unplanned further revascularization
Time Frame: 1 to 103 months (min follow-up duration: 24 months)
Unplanned further revascularization over the entire duration of follow-up
1 to 103 months (min follow-up duration: 24 months)
Canadian Cardiovascular Society class
Time Frame: 6 months, 1 year, 2 years
Canadian Cardiovascular Society (CCS) class up to 2 years
6 months, 1 year, 2 years
Brain-type Natriuretic Peptide level
Time Frame: 6 months, 1 year, 2 years
Brain natriuretic peptide (BNP or NT-Pro BNP) up to 2 years
6 months, 1 year, 2 years
Major Bleeding
Time Frame: 6 months, 1 year, 2 years
Major bleeding up to 2 years
6 months, 1 year, 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
NHS Resource Use
Time Frame: 1 to 103 months (min follow-up duration: 24 months)
Health Economic Analysis
1 to 103 months (min follow-up duration: 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

London School of Hygiene and Tropical Medicine
Guy's and St Thomas' NHS Foundation Trust
National Institute for Health Research, United Kingdom
University of York

Investigators

  • Principal Investigator: Divaka Perera, MB BChir, MA, MD, FRCP, King's College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2013

Primary Completion (Actual)

March 19, 2020

Study Completion (Actual)

March 31, 2022

Study Registration Dates

First Submitted

August 3, 2013

First Submitted That Met QC Criteria

August 8, 2013

First Posted (Estimate)

August 9, 2013

Study Record Updates

Last Update Posted (Actual)

May 31, 2022

Last Update Submitted That Met QC Criteria

May 27, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISRCTN45979711 (Other Identifier: International Standard Randomised Controlled Trial Number Register)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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