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

TY - JOUR

T1 - Percutaneous Revascularization for Ischemic Ventricular Dysfunction

T2 - Rationale and Design of the REVIVED-BCIS2 Trial: Percutaneous Coronary Intervention for Ischemic Cardiomyopathy

AU - Perera, Divaka

AU - Clayton, Tim

AU - Petrie, Mark C

AU - Greenwood, John P

AU - O'Kane, Peter D

AU - Evans, Richard

AU - Sculpher, Mark

AU - Mcdonagh, Theresa

AU - Gershlick, Anthony

AU - de Belder, Mark

AU - Redwood, Simon

AU - Carr-White, Gerald

AU - Marber, Michael

AU - REVIVED investigators

N1 - © 2018 Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an author-produced version of the published paper. Uploaded in accordance with the publisher’s self-archiving policy.

PY - 2018/6

Y1 - 2018/6

N2 - 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).

AB - 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).

KW - Journal Article

U2 - 10.1016/j.jchf.2018.01.024

DO - 10.1016/j.jchf.2018.01.024

M3 - Article

C2 - 29852933

SN - 2213-1779

VL - 6

SP - 517

EP - 526

JO - JACC. Heart failure

JF - JACC. Heart failure

IS - 6

ER -