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

King's College London

Status: Completed

Conditions: Ischemic Cardiomyopathy

Treatments: Device: Device Therapy for Heart Failure; Drug: Drug Therapy for Heart Failure; Procedure: Percutaneous Coronary Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01920048

ISRCTN45979711 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 700 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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700 participants in 2 patient groups

Percutaneous Coronary Intervention and Optimal Medical Therapy

Experimental group

Treatment:

Procedure: Percutaneous Coronary Intervention

Device: Device Therapy for Heart Failure

Drug: Drug Therapy for Heart Failure

Optimal Medical Therapy alone

Active Comparator group

Treatment:

Device: Device Therapy for Heart Failure

Drug: Drug Therapy for Heart Failure