Effect of PCI on Health Status in Ischemic Left Ventricular Dysfunction
M. J. Ryan, Dylan A. Taylor, Matthew Dodd, John A. Spertus, Mikhail Kosiborod, Aadil Shaukat, Kieran F. Docherty, Tim Clayton, Divaka Perera, 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 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 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, Dwayne Conway, Paul Brooksby, Judith Wright, Donna Exley, James Cotton, Richard Horton, Stella Metherell, Andrew Smallwood, Kai Hogrefe, Adrian S. H. Cheng, Charmaine Beirnes, Sian Sidgwick, Tim Lockie, Niket Patel
Abstract
BACKGROUND: In the REVIVED-BCIS2 (Revascularization for Ischemic Ventricular Dysfunction) trial, percutaneous coronary intervention (PCI) did not reduce the incidence of death or hospitalization for heart failure (HHF). OBJECTIVES: This prespecified secondary analysis investigated the effect of PCI on health status measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) combined with the primary outcome in a win ratio. METHODS: Participants with severe ischemic left ventricular dysfunction were randomized to either PCI in addition to optimal medical therapy (OMT) (PCI) or OMT alone (OMT). The primary outcome was a hierarchical composite of all-cause death, HHF, and KCCQ-Overall Summary Score (OSS) at 24 months analyzed using the unmatched win ratio. The key secondary endpoint was a KCCQ-OSS responder analysis. RESULTS: A total of 347 participants were randomized to PCI and 353 to OMT. Median age was 70.0 years (Q1-Q3: 63.3-76.1 years). Mean left ventricular ejection fraction was 27.0 ± 6.7%. PCI did not improve the primary endpoint (win ratio for PCI vs OMT: 1.05; 95% CI: 0.88-1.26; P = 0.58). PCI resulted in more KCCQ-OSS responders than OMT at 6 months (54.1% vs 40.7%; OR: 1.96; 95% CI: 1.41-2.71; P < 0.001) and fewer deteriorators (25.2% vs 31.4%; OR: 0.69; 95% CI: 0.47-1.00; P = 0.048). PCI did not impact KCCQ-OSS responders or deteriorators at 12 or 24 months. CONCLUSIONS: PCI did not improve the hierarchical composite of death, HHF, and health status at 2 years. PCI improved KCCQ-OSS at 6 months, but this benefit was not sustained to 1- or 2-year follow-up. (Revacularization for Ischemic Ventricular Dysfunction [REVIVED-BCIS2]; NCT01920048).