Arrhythmia and Death Following Percutaneous Revascularization in Ischemic Left Ventricular Dysfunction: Prespecified Analyses From the REVIVED-BCIS2 Trial
Authors: Perera Divaka , Morgan Holly P. , Ryan Matthew , Dodd Matthew , Clayton Tim , O’Kane Peter D. , Greenwood John P. , Walsh Simon J. , Weerackody Roshan , McDiarmid Adam , Amin-Youssef George , Strange Julian , Modi Bhavik , Lockie Timothy , Hogrefe Kai , Ahmed Fozia Z. , Behan Miles , Jenkins Nicholas , Abdelaal Eltigani , Anderson Michelle , Watkins Stuart , Evans Richard , Rinaldi Christopher A. , Petrie Mark C. , Perera Divaka , Chiribiri Amedeo , Carr-White Gerry , Pavlidis Antonis , Redwood Simon , Clapp Brian , Rinaldi Aldo , Rahman Haseeb , Briceno Natalia , Arnold Sophie , Raynsford Amy , Wilson Karen , Clack Lucy , Petrie Mark , McEntegart Margaret , Watkins Stuart , Shaukat Aadil , Rocchiccioli Paul , McAdam Marion , McPherson Elizabeth , Cowan Louise , Wood Marie , Weerackody Roshan , Davies Ceri , Smith Elliot , Modi Bhavik , Mathew Bindu , Mitchelmore Oliver , Adrego Rita , Andiapen Mervyn , O’Kane Peter , Din Jehangir , Kennard Sarah , Orr Sarah , Purnell Cathie , Greenwood John , Blaxill Jonathan , Mozid Abdul , Anderson Michelle , Somers Kathryn , Dixon Lana , Walsh Simon , Spence Mark , Glover Patricia , Brown Caroline , Edwards Richard , McDiarmid Adam , Egred Mohaned , Narytnyk Alla , Wealleans Vera , Amin-Youssef George , Shah Ajay , McDonagh Theresa , Byrne Jonathan , Pareek Nilesh , Breeze Jonathan , Antao Catherine , De Silva Kalpa , Strange Julian , Johnson Tom , Nightingale Angus , Gallego Laura , Medina Cristina , Gershlick Anthony , McCann Gerald , Ladwiniec Andrew , Squire Iain , Davison Joanna , Kenmuir-Hogg Kris , Spratt James , Cosgrove Claudia , Williams Rupert , Firoozi Sam , Lim Pitt , Bonato Giovanna , Sookhoo Vennessa , Conway Dwayne , Brooksby Paul , Wright Judith , Exley Donna , Cotton James , Horton Richard , Metherell Stella , Smallwood Andrew , Hogrefe Kai , Cheng Adrian , Beirnes Charmaine , Sidgwick Sian , Lockie Tim , Patel Niket , Rakhit Roby , Davies Nina , Smit Angelique , Ahmed Fozia , Hendry Cara , Fath-Odoubadi Farzin , Fraser Douglas , Mamas Mamas , Oommen Anu , Charles Thabitha , Behan Miles , Japp Alan , Rif Belinda , Jenkins Nicholas , McClure Sam , Oates Pauline , Martin Karen , Abdelaal Eltigani , Sarma Jaydeep , Shastri Sanjay , Riley Jo , Giannopoulou Sarra , Quinn Sophie , Magapu Pradeep , Stables Rod , Wright David , Barton Janet , Clarkson Nichola , Mahmoudi Michael , Flett Andrew , Curzen Nick , Radmore Judith , Gough Sam , Ludman Andrew , Kurdi Hibba , Keenan Samantha , Banerjee Prithwish , Tapp Luke , Edwards Nigel , Gibson Catherine , Kukreja Neville , Lynch Mary , Barratt Claire , de Belder Mark , Thambyrajah Jeet , Swanson Neil , Richardson Cath , Atkinson Bev , Viswanathan Girish , Waugh Darren , Routledge Helen , Trevelyan Jasper , Doughty Angela , Pegge Nick , Dhamrait Sukhbir , Moore Sally , Galasko Gavin , Cassidy Christopher , Waddington Natalia , Edwards Tim , Iqbal Javed , Witherow Fraser , Birch Jenny , Munro Melanie , Wells Tim , Sinha Manas , Frost Linda , Lee Kaeng , Beattie James , Pitt Mike , Chung Alan , Ramcharitar Steve , McCafferty Laura , Martin Thomas , Irving John , Iskandar Zaid , Hutcheon Anita , Gunn Julian , Al-Mohammad Abdallah , Agyemang Michael , Griffiths Huw , Kalra Paul , Howe Serena , Gray Tim , Sobolewska Jolanta , Morby Louise , Glover Jason , Beynon James , Knight Janet , Das Paul , Bellamy Chris , Harman Emily , Pye Maurice , Megarry Simon , McGill Yvonne , Redfearn Heidi 
Published: August 2023

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.