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Percutaneous Revascularization for Ischemic Ventricular Dysfunction: Rationale and Design of the REVIVED-BCIS2 Trial:
Divaka Perera1, Tim Clayton2, Mark C Petrie3
1National Institute for Health Research Biomedical Research Centre and British Heart Foundation Centre of Excellence, School of Cardiovascular Medicine and Sciences, King's College London, London, United Kingdom.
Insights
This study evaluates if percutaneous coronary intervention (PCI) plus optimal medical therapy (OMT) reduces death and heart failure hospitalizations compared to OMT alone in ischemic cardiomyopathy patients. Results will inform clinical guidelines for revascularization and heart failure management.
Area of Science:
- Cardiology
- Interventional Cardiology
- Heart Failure Research
Background:
- Ischemic cardiomyopathy (ICM) is a leading cause of heart failure (HF), associated with high mortality and morbidity.
- While surgical revascularization improves outcomes, it carries significant risks.
- Percutaneous coronary intervention (PCI) offers a potentially safer alternative for managing ICM.
Purpose of the Study:
- To evaluate the efficacy of PCI combined with optimal medical therapy (OMT) in reducing all-cause death and heart failure hospitalizations.
- To compare a strategy of PCI plus OMT against OMT alone in patients with severe ischemic cardiomyopathy.
- To provide robust evidence for international guideline development regarding revascularization in heart failure.
Main Methods:
- The REVIVED-BCIS2 trial is a prospective, multi-center, open-label, randomized controlled trial.
- Eligible patients have LVEF ≤35%, extensive coronary disease, and viable myocardium.
- Exclusion criteria include recent myocardial infarction, decompensated HF, or sustained ventricular arrhythmias.
Main Results:
- The trial aims to enroll 700 patients with over 85% power to detect a 30% relative risk reduction.
- Currently, 400 patients have been enrolled in the study.
- Secondary outcomes include improvements in left ventricular ejection fraction (LVEF) and quality of life.
Conclusions:
- Current international guidelines lack definitive recommendations for PCI in severe ICM due to insufficient evidence.
- The REVIVED-BCIS2 trial will provide the first randomized data on PCI's efficacy and safety in ICM.
- Findings have the potential to significantly influence future management strategies and guidelines for revascularization in heart failure.
Objectives:
Evaluate whether PCI in combination with optimal medical therapy (OMT) will reduce all-cause death and hospitalization for HF compared to a strategy of OMT alone.
Background:
Ischemic cardiomyopathy (ICM) is the most common cause of heart failure (HF) and is associated with significant mortality and morbidity. Surgical revascularization has been shown to improve long-term outcomes in some patients, but surgery itself carries a major early hazard. Percutaneous coronary intervention (PCI) may allow a better balance between risk and benefit.
Methods:
REVIVED-BCIS2 is a prospective, multi-center, open-label, randomized controlled trial, funded by the National Institute for Health Research in the United Kingdom. Follow-up will be for at least 2 years from randomization. Secondary outcomes include left ventricular ejection fraction (LVEF), quality of life scores, appropriate implantable cardioverter defibrillator therapy and acute myocardial infarction. Patients with LVEF ≤35%, extensive coronary disease and demonstrable myocardial viability are eligible for inclusion and those with a myocardial infarction within 4 weeks, decompensated HF or sustained ventricular arrhythmias within 72 h are excluded. A trial of 700 patients has more than 85% power to detect a 30% relative reduction in hazard.
Results:
A total of 400 patients have been enrolled to date.
Conclusions:
International guidelines do not provide firm recommendations on the role of PCI in managing severe ICM, because of a lack of robust evidence. REVIVED-BCIS2 will provide the first randomized data on the efficacy and safety of PCI in ICM and has the potential to inform guidelines pertaining to both revascularization and HF. (Study of Efficacy and Safety of Percutaneous Coronary Intervention to Improve Survival in Heart Failure [REVIVED-BCIS2]; NCT01920048) (REVascularisation for Ischaemic VEntricular Dysfunction; ISRCTN45979711).
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