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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01920048
Recruitment Status : Completed
First Posted : August 9, 2013
Last Update Posted : May 31, 2022
Sponsor:
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
Information provided by (Responsible Party):
Divaka Perera, King's College London

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ischemic Cardiomyopathy Procedure: Percutaneous Coronary Intervention Drug: Drug Therapy for Heart Failure Device: Device Therapy for Heart Failure Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 28, 2013
Actual Primary Completion Date : March 19, 2020
Actual Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Percutaneous Coronary Intervention and Optimal Medical Therapy Procedure: Percutaneous Coronary Intervention
Other Name: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Left Ventricular Ejection Fraction [ Time Frame: 6 months, 1 year ]
    Left Ventricular Ejection Fraction (LVEF) on echocardiography

  2. 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.

  3. New York Heart Association Functional (NYHA) Class [ Time Frame: 6 months, 1 year, 2 years ]
  4. Cardiovascular Death [ Time Frame: 1 to 103 months (min follow-up duration: 24 months) ]
    Cardiovascular death over the entire duration of follow-up

  5. 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

  6. 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

  7. 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

  8. Appropriate Implantable Cardioverter Defibrillator Therapy [ Time Frame: 6 months, 1 year, 2 years ]
    Appropriate implantable cardioverter defibrillator (ICD) therapy to 2 years

  9. 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

  10. Canadian Cardiovascular Society class [ Time Frame: 6 months, 1 year, 2 years ]
    Canadian Cardiovascular Society (CCS) class up to 2 years

  11. 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

  12. Major Bleeding [ Time Frame: 6 months, 1 year, 2 years ]
    Major bleeding up to 2 years


Other Outcome Measures:
  1. NHS Resource Use [ Time Frame: 1 to 103 months (min follow-up duration: 24 months) ]
    Health Economic Analysis


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920048


Locations
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Sponsors and Collaborators
King's College London
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
Investigators
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Principal Investigator: Divaka Perera, MB BChir, MA, MD, FRCP King's College London
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Divaka Perera, Consultant Cardiologist and Professor of Cardiology, King's College London
ClinicalTrials.gov Identifier: NCT01920048    
Other Study ID Numbers: ISRCTN45979711
ISRCTN45979711 ( Other Identifier: International Standard Randomised Controlled Trial Number Register )
First Posted: August 9, 2013    Key Record Dates
Last Update Posted: May 31, 2022
Last Verified: May 2022
Keywords provided by Divaka Perera, King's College London:
Heart Failure
Ventricular Dysfunction
Ischemic Cardiomyopathy
Ischemic Heart Disease
 Revascularization
Percutaneous Coronary Intervention
Randomized Control Trial
Implantable Cardioverter Defibrillator
Additional relevant MeSH terms:
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Heart Failure
Cardiomyopathies
Ventricular Dysfunction
Ischemia
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes