REVascularisation for Ischaemic VEntricular Dysfunction

Conditions

Cardiology, heart failure Circulatory System Heart failure

Ahmet Sen, Richard E. Jones, Holly Morgan, Hassan Zaidi, Brian P. Halliday et al. (10 authors)

npj Cardiovascular Health2026-07-04

Percutaneous Revascularization for Ischemic Ventricular Dysfunction: Rationale and Design of the REVIVED-BCIS2 Trial: Percutaneous Coronary Intervention for Ischemic Cardiomyopathy.

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.

2018-06-0169 citations

10.1016/j.jchf.2018.01.024

Interventions

Patients are randomised to receive either Optimal Medical Therapy (OMT) alone or Percutaneous Coronary Intervention (PCI) and OMT.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 13/08/2014: 1. LVEF =35% 2. Extensive coronary disease (BCIS-1 Jeopardy Score =6) 3. Viability in at least 4 dysfunctional segments, that can be revascularised by PCI Previous inclusion criteria: 1. LVEF =30% 2. Extensive coronary disease (BCIS-1 Jeopardy Score =6) 3. Viable myocardium in =30% of dysfunctional segments

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 14/09/2018: 1. Myocardial infarction 3 7. Active internal bleeding (except menstruation) 8. Platelet count < 100,000 cells/mm3) at randomisation 9. Haemoglobin < 9 g/dl at randomisation 10. eGFR < 25 ml/min, unless established on dialysis 11. Women who are pregnant 12. Previously enrolled in REVIVED or current enrolment in other study 13. Life expectancy < 1 year due to non-cardiac pathology

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 23/10/2018: A composite of all-cause death and hospitalisation due to heart failure with a minimum follow-up of 2 years and maximum follow-up of approximately 8.5 years depending on time of randomisation. Previous primary outcome measure as of 14/09/2018: A composite of all-cause death and hospitalisation due to heart failure Previous primary outcome measures: 1. All-cause death 2. Acute myocardial infarction or hospitalisation due to heart failure (hierarchy: death > MI > heart failure)	—

Measure

Time frame

Current primary outcome measure as of 23/10/2018: A composite of all-cause death and hospitalisation due to heart failure with a minimum follow-up of 2 years and maximum follow-up of approximately 8.5 years depending on time of randomisation. Previous primary outcome measure as of 14/09/2018: A composite of all-cause death and hospitalisation due to heart failure Previous primary outcome measures: 1. All-cause death 2. Acute myocardial infarction or hospitalisation due to heart failure (hierarchy: death > MI > heart failure)

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Secondary

Measure	Time frame
Current secondary outcome measures as of 21/04/2022: 1. Left Ventricular Ejection Fraction (LVEF) on echocardiography at 6 months and 1 year 2. Quality of life score: 2.1. Kansas City Cardiomyopathy questionnaire (KCCQ) up to 2 years 2.2. EuroQol EQ-5D-5L at 6 months and then yearly to the end of follow-up 3. New York Heart Association Functional (NYHA) Class up to 2 years 4. Cardiovascular death over the entire duration of follow-up 5. All-cause death over the entire duration of follow-up 6. Hospitalisation due to heart failure over the entire duration of follow-up 7. Acute myocardial infarction (MI) over the entire duration of follow-up 8. Appropriate implantable cardioverter defibrillator (ICD) therapy to 2 years 9. Unplanned further revascularisation over the entire duration of follow-up 10. Canadian Cardiovascular Society (CCS) up to 2 years 11. NHS resource use 12. Brain natriuretic peptide (BNP or NT-Pro BNP) up to 2 years 13. Major bleeding up to 2 years Previous secondary outcome measures: 1. Cardiovascular death, MI, CVA or unplanned revascularisation at 30-days 2. Left ventricular ejection fraction at 6 months, 1 year 3. Cardiovascular death or myocardial infarction 4. Hospitalisation for heart failure 5. Appropriate ICD therapy 6. Unplanned further revascularisation 7. Acute coronary syndrome	—

Measure

Time frame

Current secondary outcome measures as of 21/04/2022: 1. Left Ventricular Ejection Fraction (LVEF) on echocardiography at 6 months and 1 year 2. Quality of life score: 2.1. Kansas City Cardiomyopathy questionnaire (KCCQ) up to 2 years 2.2. EuroQol EQ-5D-5L at 6 months and then yearly to the end of follow-up 3. New York Heart Association Functional (NYHA) Class up to 2 years 4. Cardiovascular death over the entire duration of follow-up 5. All-cause death over the entire duration of follow-up 6. Hospitalisation due to heart failure over the entire duration of follow-up 7. Acute myocardial infarction (MI) over the entire duration of follow-up 8. Appropriate implantable cardioverter defibrillator (ICD) therapy to 2 years 9. Unplanned further revascularisation over the entire duration of follow-up 10. Canadian Cardiovascular Society (CCS) up to 2 years 11. NHS resource use 12. Brain natriuretic peptide (BNP or NT-Pro BNP) up to 2 years 13. Major bleeding up to 2 years Previous secondary outcome measures: 1. Cardiovascular death, MI, CVA or unplanned revascularisation at 30-days 2. Left ventricular ejection fraction at 6 months, 1 year 3. Cardiovascular death or myocardial infarction 4. Hospitalisation for heart failure 5. Appropriate ICD therapy 6. Unplanned further revascularisation 7. Acute coronary syndrome

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Countries

England, Northern Ireland, Scotland, United Kingdom, Wales

Contacts

Public ContactRuth Canter

Ruth.Canter@lshtm.ac.uk+44 20 7927 2071

Outcome results

None listed