TY - JOUR
T1 - Arrhythmia and Death Following Percutaneous Revascularization in Ischemic Left Ventricular Dysfunction
T2 - Prespecified Analyses From the REVIVED-BCIS2 Trial
AU - REVIVED-BCIS2 Investigators
AU - Perera, Divaka
AU - Morgan, Holly P
AU - Ryan, Matthew
AU - Dodd, Matthew
AU - Clayton, Tim
AU - O'Kane, Peter D
AU - Greenwood, John P
AU - Walsh, Simon J
AU - Weerackody, Roshan
AU - McDiarmid, Adam
AU - Amin-Youssef, George
AU - Strange, Julian
AU - Modi, Bhavik
AU - Lockie, Timothy
AU - Hogrefe, Kai
AU - Ahmed, Fozia Z
AU - Behan, Miles
AU - Jenkins, Nicholas
AU - Abdelaal, Eltigani
AU - Anderson, Michelle
AU - Watkins, Stuart
AU - Evans, Richard
AU - Rinaldi, Christopher A
AU - Petrie, Mark C
N1 - Funding Information:
The trial was sponsored by King’s College London and funded by the National Institute for Health and Care Research Health Technology Assessment Program. The arrhythmia analyses were supported by the British Heart Foundation (fellowship FS/CRTF/21/24190 and the King’s British Heart Foundation Center of Research Excellence grant RE/18/2/34213).
Publisher Copyright:
© 2023 Lippincott Williams and Wilkins. All rights reserved.
PY - 2023/9/12
Y1 - 2023/9/12
N2 - BACKGROUND: Ventricular arrhythmia is an important cause of mortality in patients with ischemic left ventricular dysfunction. Revascularization with coronary artery bypass graft or percutaneous coronary intervention is often recommended for these patients before implantation of a cardiac defibrillator because it is assumed that this may reduce the incidence of fatal and potentially fatal ventricular arrhythmias, although this premise has not been evaluated in a randomized trial to date.METHODS: Patients with severe left ventricular dysfunction, extensive coronary disease, and viable myocardium were randomly assigned to receive either percutaneous coronary intervention (PCI) plus optimal medical and device therapy (OMT) or OMT alone. The composite primary outcome was all-cause death or aborted sudden death (defined as an appropriate implantable cardioverter defibrillator therapy or a resuscitated cardiac arrest) at a minimum of 24 months, analyzed as time to first event on an intention-to-treat basis. Secondary outcomes included cardiovascular death or aborted sudden death, appropriate implantable cardioverter defibrillator (ICD) therapy or sustained ventricular arrhythmia, and number of appropriate ICD therapies.RESULTS: Between August 28, 2013, and March 19, 2020, 700 patients were enrolled across 40 centers in the United Kingdom. A total of 347 patients were assigned to the PCI+OMT group and 353 to the OMT alone group. The mean age of participants was 69 years; 88% were male; 56% had hypertension; 41% had diabetes; and 53% had a clinical history of myocardial infarction. The median left ventricular ejection fraction was 28%; 53.1% had an implantable defibrillator inserted before randomization or during follow-up. All-cause death or aborted sudden death occurred in 144 patients (41.6%) in the PCI group and 142 patients (40.2%) in the OMT group (hazard ratio, 1.03 [95% CI, 0.82-1.30]; P=0.80). There was no between-group difference in the occurrence of any of the secondary outcomes.CONCLUSIONS: PCI was not associated with a reduction in all-cause mortality or aborted sudden death. In patients with ischemic cardiomyopathy, PCI is not beneficial solely for the purpose of reducing potentially fatal ventricular arrhythmias.REGISTRATION: URL: https://www.CLINICALTRIALS: gov; Unique identifier: NCT01920048.
AB - BACKGROUND: Ventricular arrhythmia is an important cause of mortality in patients with ischemic left ventricular dysfunction. Revascularization with coronary artery bypass graft or percutaneous coronary intervention is often recommended for these patients before implantation of a cardiac defibrillator because it is assumed that this may reduce the incidence of fatal and potentially fatal ventricular arrhythmias, although this premise has not been evaluated in a randomized trial to date.METHODS: Patients with severe left ventricular dysfunction, extensive coronary disease, and viable myocardium were randomly assigned to receive either percutaneous coronary intervention (PCI) plus optimal medical and device therapy (OMT) or OMT alone. The composite primary outcome was all-cause death or aborted sudden death (defined as an appropriate implantable cardioverter defibrillator therapy or a resuscitated cardiac arrest) at a minimum of 24 months, analyzed as time to first event on an intention-to-treat basis. Secondary outcomes included cardiovascular death or aborted sudden death, appropriate implantable cardioverter defibrillator (ICD) therapy or sustained ventricular arrhythmia, and number of appropriate ICD therapies.RESULTS: Between August 28, 2013, and March 19, 2020, 700 patients were enrolled across 40 centers in the United Kingdom. A total of 347 patients were assigned to the PCI+OMT group and 353 to the OMT alone group. The mean age of participants was 69 years; 88% were male; 56% had hypertension; 41% had diabetes; and 53% had a clinical history of myocardial infarction. The median left ventricular ejection fraction was 28%; 53.1% had an implantable defibrillator inserted before randomization or during follow-up. All-cause death or aborted sudden death occurred in 144 patients (41.6%) in the PCI group and 142 patients (40.2%) in the OMT group (hazard ratio, 1.03 [95% CI, 0.82-1.30]; P=0.80). There was no between-group difference in the occurrence of any of the secondary outcomes.CONCLUSIONS: PCI was not associated with a reduction in all-cause mortality or aborted sudden death. In patients with ischemic cardiomyopathy, PCI is not beneficial solely for the purpose of reducing potentially fatal ventricular arrhythmias.REGISTRATION: URL: https://www.CLINICALTRIALS: gov; Unique identifier: NCT01920048.
KW - Humans
KW - Male
KW - Aged
KW - Female
KW - Stroke Volume
KW - Death, Sudden, Cardiac/epidemiology
KW - Ventricular Function, Left
KW - Arrhythmias, Cardiac/etiology
KW - Ventricular Dysfunction, Left/etiology
KW - Defibrillators, Implantable/adverse effects
KW - Treatment Outcome
UR - http://www.scopus.com/inward/record.url?scp=85170717477&partnerID=8YFLogxK
U2 - 10.1161/CIRCULATIONAHA.123.065300
DO - 10.1161/CIRCULATIONAHA.123.065300
M3 - Article
C2 - 37555345
SN - 0009-7322
VL - 148
SP - 862
EP - 871
JO - Circulation
JF - Circulation
IS - 11
ER -
