Arrhythmia and Death Following Percutaneous Revascularization in Ischemic Left Ventricular Dysfunction: Prespecified Analyses From the REVIVED-BCIS2 Trial
Divaka Perera, Holly Morgan, M. J. Ryan, Matthew Dodd, Tim Clayton, Peter O’Kane, John P. Greenwood, Simon Walsh, Roshan Weerackody, Adam K McDiarmid, George Amin‐Youssef, Julian Strange, Bhavik Modi, Timothy Lockie, Kai Hogrefe, Fozia Ahmed, Miles Behan, Nicholas Jenkins, Eltigani Abdelaal, Michelle A. Anderson, Stuart Watkins, Richard D. Evans, Christopher A. Rinaldi, Mark C. Petrie, Divaka Perera, Amedeo Chiribiri, Gerry Carr‐White, Antonis N. Pavlidis, Simon Redwood, Brian Clapp, Christopher A. Rinaldi, Haseeb Rahman, Natalia Briceno, Sophie Arnold, Amy Raynsford, Karen M. Wilson, Lucy Clack, Mark C. Petrie, Margaret McEntegart, Stuart Watkins, Aadil Shaukat, Paul Rocchiccioli, Marion McAdam, Elizabeth McPherson, Louise Cowan, Marie Wood, Roshan Weerackody, Ceri H. Davies, Elliot J. Smith, Bhavik Modi, Bindu Mathew, Oliver Mitchelmore, Rita Adrego, Mervyn Andiapen, Peter O’Kane, Jehangir Din, Sarah Kennard, Sarah Orr, Cathie Purnell, John P. Greenwood, Jonathan Blaxill, Abdul Mozid, Michelle A. Anderson, Kathryn Somers, Lana Dixon, Simon Walsh, Mark Spence, P. E. Glover, Caroline Brown, Richard Edwards, Adam K McDiarmid, Mohaned Egred, Alla Narytnyk, Vera Wealleans, George Amin‐Youssef, Ajay M. Shah, Theresa A. McDonagh, Jonathan Byrne, Nilesh Pareek, Jonathan Breeze, Catherine Antao, Kalpa De Silva, Julian Strange, Tom Johnson, Angus K. Nightingale, Laura Gallego, Cristina Medina, Anthony Gershlick, Gerald McCann, Andrew Ladwiniec, Iain Squire, Joanna Davison, Kris Kenmuir-Hogg, James Spratt, Claudia Cosgrove, Rupert Williams, Sam Firoozi, Pitt Lim, Giovanna Bonato, Vennessa Sookhoo
Abstract
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.