Clinical trial NCT01920048: Study of Efficacy and Safety of Percutaneous Coronary Intervention to Improve Survival in Heart Failure
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
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Cardiomyopathy
Keywords: Heart Failure
Ventricular Dysfunction
Ischemic Cardiomyopathy
Ischemic Heart Disease
Revascularization
Percutaneous Coronary Intervention
Randomized Control Trial
Implantable Cardioverter Defibrillator
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: London School of Hygiene and Tropical Medicine
name: University of York
name: Guy's and St Thomas' NHS Foundation Trust
First posted: 2013-08-09
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: All-cause death or Hospitalization for Heart Failure
timeFrame: 1 to 103 months (min follow-up duration: 24 months)
Secondary outcomes:
measure: Left Ventricular Ejection Fraction
timeFrame: 6 months, 1 year
measure: Quality of Life Scores
timeFrame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years
measure: New York Heart Association Functional (NYHA) Class
timeFrame: 6 months, 1 year, 2 years
measure: Cardiovascular Death
timeFrame: 1 to 103 months (min follow-up duration: 24 months)
measure: All-cause death
timeFrame: 1 to 103 months (min follow-up duration: 24 months)
measure: Hospitalization due to heart failure
timeFrame: 1 to 103 months (min follow-up duration: 24 months)
measure: Acute Myocardial Infarction
timeFrame: 1 to 103 months (min follow-up duration: 24 months)
measure: Appropriate Implantable Cardioverter Defibrillator Therapy
timeFrame: 6 months, 1 year, 2 years
measure: Unplanned further revascularization
timeFrame: 1 to 103 months (min follow-up duration: 24 months)
measure: Canadian Cardiovascular Society class
timeFrame: 6 months, 1 year, 2 years
measure: Brain-type Natriuretic Peptide level
timeFrame: 6 months, 1 year, 2 years
measure: Major Bleeding
timeFrame: 6 months, 1 year, 2 years
Other outcomes:
measure: NHS Resource Use
timeFrame: 1 to 103 months (min follow-up duration: 24 months)
Locations:
city: Basingstoke
country: United Kingdom
facility: Basingstoke and North Hampshire Hospital
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
city: Bodelwyddan
country: United Kingdom
facility: North Wales Cardiac Centre
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Bristol
country: United Kingdom
facility: Bristol Heart Institute
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
city: Dorchester
country: United Kingdom
facility: Dorset County Hospital
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Kettering
country: United Kingdom
facility: Kettering General Hospital
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital
city: London
country: United Kingdom
facility: Barts Heart Centre
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Guy's and St Thomas' Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: St George's Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Middlesbrough
country: United Kingdom
facility: The James Cook University Hospital
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
city: Oldham
country: United Kingdom
facility: Royal Oldham Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
city: Salisbury
country: United Kingdom
facility: Salisbury District Hospital
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
city: Stevenage
country: United Kingdom
facility: Lister Hospital
city: Sunderland
country: United Kingdom
facility: Sunderland Royal Hospital
city: Swindon
country: United Kingdom
facility: Great Western Hospital
city: Wakefield
country: United Kingdom
facility: Pinderfields Hospital
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
city: Worcester
country: United Kingdom
facility: Worcestershire Royal Hospital
city: Worthing
country: United Kingdom
facility: Worthing Hospital
city: Wythenshawe
country: United Kingdom
facility: Wythenshawe Hospital
city: York
country: United Kingdom
facility: York Hospital
Study officials:
affiliation: King's College London
name: Divaka Perera, MB BChir, MA, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.