Arrhythmia and death following percutaneous revascularization in ischemic left ventricular dysfunction: Prespecified analyses from the REVIVED-BCIS2 trial

Perera, D. et al. (2023) Arrhythmia and death following percutaneous revascularization in ischemic left ventricular dysfunction: Prespecified analyses from the REVIVED-BCIS2 trial. Circulation: Heart Failure, 148(11), pp. 862-871. (doi: 10.1161/circulationaha.123.065300) (PMID:37555345) (PMCID:PMC10487377)

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.

• Item Type: Articles
• Additional 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 (fellow-ship FS/CRTF/21/24190 and the King’s British Heart Foundation Center of Research Excellence grant RE/18/2/34213).
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Watkins, Dr Stuart and Petrie, Professor Mark
• Authors: Perera, D., Morgan, H. P., Ryan, M., Dodd, M., Clayton, T., O’Kane, P. D., Greenwood, J. P., Walsh, S. J., Weerackody, R., McDiarmid, A., Amin-Youssef, G., Strange, J., Modi, B., Lockie, T., Hogrefe, K., Ahmed, F. Z., Behan, M., Jenkins, N., Abdelaal, E., Anderson, M., Watkins, S., Evans, R., Rinaldi, C. A., Petrie, M. C., Perera, D., Chiribiri, A., Carr-White, G., Pavlidis, A., Redwood, S., Clapp, B., Rinaldi, A., Rahman, H., Briceno, N., Arnold, S., Raynsford, A., Wilson, K., Clack, L., Petrie, M., McEntegart, M., Watkins, S., Shaukat, A., Rocchiccioli, P., McAdam, M., McPherson, E., Cowan, L., Wood, M., Weerackody, R., Davies, C., Smith, E., Modi, B., Mathew, B., Mitchelmore, O., Adrego, R., Andiapen, M., O’Kane, P., Din, J., Kennard, S., Orr, S., Purnell, C., Greenwood, J., Blaxill, J., Mozid, A., Anderson, M., Somers, K., Dixon, L., Walsh, S., Spence, M., Glover, P., Brown, C., Edwards, R., McDiarmid, A., Egred, M., Narytnyk, A., Wealleans, V., Amin-Youssef, G., Shah, A., McDonagh, T., Byrne, J., Pareek, N., Breeze, J., Antao, C., De Silva, K., Strange, J., Johnson, T., Nightingale, A., Gallego, L., Medina, C., Gershlick, A., McCann, G., Ladwiniec, A., Squire, I., Davison, J., Kenmuir-Hogg, K., Spratt, J., Cosgrove, C., Williams, R., Firoozi, S., Lim, P., Bonato, G., Sookhoo, V., Conway, D., Brooksby, P., Wright, J., Exley, D., Cotton, J., Horton, R., Metherell, S., Smallwood, A., Hogrefe, K., Cheng, A., Beirnes, C., Sidgwick, S., Lockie, T., Patel, N., Rakhit, R., Davies, N., Smit, A., Ahmed, F., Hendry, C., Fath-Odoubadi, F., Fraser, D., Mamas, M., Oommen, A., Charles, T., Behan, M., Japp, A., Rif, B., Jenkins, N., McClure, S., Oates, P., Martin, K., Abdelaal, E., Sarma, J., Shastri, S., Riley, J., Giannopoulou, S., Quinn, S., Magapu, P., Stables, R., Wright, D., Barton, J., Clarkson, N., Mahmoudi, M., Flett, A., Curzen, N., Radmore, J., Gough, S., Ludman, A., Kurdi, H., Keenan, S., Banerjee, P., Tapp, L., Edwards, N., Gibson, C., Kukreja, N., Lynch, M., Barratt, C., de Belder, M., Thambyrajah, J., Swanson, N., Richardson, C., Atkinson, B., Viswanathan, G., Waugh, D., Routledge, H., Trevelyan, J., Doughty, A., Pegge, N., Dhamrait, S., Moore, S., Galasko, G., Cassidy, C., Waddington, N., Edwards, T., Iqbal, J., Witherow, F., Birch, J., Munro, M., Wells, T., Sinha, M., Frost, L., Lee, K., Beattie, J., Pitt, M., Chung, A., Ramcharitar, S., McCafferty, L., Martin, T., Irving, J., Iskandar, Z., Hutcheon, A., Gunn, J., Al-Mohammad, A., Agyemang, M., Griffiths, H., Kalra, P., Howe, S., Gray, T., Sobolewska, J., Morby, L., Glover, J., Beynon, J., Knight, J., Das, P., Bellamy, C., Harman, E., Pye, M., Megarry, S., McGill, Y., and Redfearn, H.
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
• Journal Name: Circulation: Heart Failure
• Publisher: Lippincott Williams and Wilkins
• ISSN: 1941-3289
• ISSN (Online): 1524-4539
• Published Online: 09 August 2023
• Copyright Holders: Copyright: © 2023 The Authors
• First Published: First published in Circulation: Heart Failure 148(11): 862-871
• Publisher Policy: Reproduced under a Creative Commons licence