Study of Efficacy and Safety of Percutaneous Coronary Intervention to Improve Survival in Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Ischemic Cardiomyopathy

Intervention / Treatment
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* Procedure: Percutaneous Coronary Intervention
* Drug: Drug Therapy for Heart Failure
* Device: Device Therapy for Heart Failure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Percutaneous Coronary Intervention and Optimal Medical Therapy<br> | Procedure: Percutaneous Coronary Intervention<br> <br> * Other names: Coronary angioplasty/stents;Drug: Drug Therapy for Heart Failure<br>* 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<br>Device: Device Therapy for Heart Failure<br>* 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.<br>|
| Active Comparator: Optimal Medical Therapy alone<br> | Drug: Drug Therapy for Heart Failure<br>* 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<br>Device: Device Therapy for Heart Failure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular Ejection Fraction | Left Ventricular Ejection Fraction (LVEF) on echocardiography | 6 months, 1 year | 
| 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. | 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 | Cardiovascular death over the entire duration of follow-up | 1 to 103 months (min follow-up duration: 24 months) | 
| All-cause death | 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 | 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 | 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 | Appropriate implantable cardioverter defibrillator (ICD) therapy to 2 years | 6 months, 1 year, 2 years | 
| Unplanned further revascularization | Unplanned further revascularization over the entire duration of follow-up | 1 to 103 months (min follow-up duration: 24 months) | 
| Canadian Cardiovascular Society class | Canadian Cardiovascular Society (CCS) class up to 2 years | 6 months, 1 year, 2 years | 
| Brain-type Natriuretic Peptide level | Brain natriuretic peptide (BNP or NT-Pro BNP) up to 2 years | 6 months, 1 year, 2 years | 
| Major Bleeding | Major bleeding up to 2 years | 6 months, 1 year, 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Revascularization, Heart Failure, Ventricular Dysfunction, Ischemic Cardiomyopathy, Ischemic Heart Disease, Percutaneous Coronary Intervention, Randomized Control Trial, Implantable Cardioverter Defibrillator