Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction

Divaka Perera Tim Clayton Peter D O'Kane John P Greenwood Roshan Weerackody Matthew Ryan Holly P Morgan Matthew Dodd Richard Evans Ruth Canter Sophie Arnold Lana J Dixon Richard J Edwards Kalpa De Silva James C Spratt Dwayne Conway James Cotton Margaret McEntegart Amedeo Chiribiri Pedro Saramago Anthony Gershlick Ajay M Shah Andrew L Clark Mark C Petrie REVIVED-BCIS2 Investigators

REVIVED was published in the New England Journal of Medicine on Saturday. Divaka Perera from St Thomas's in London was the first author and Chief Investigator. Mark Petrie, University of Glasgow, was the senior author. There were major contributions from the Glasgow team across University of Glasgow and NHS Golden Jubilee (Margarer McEntegart, Aadil Shaukat, Stuart Watkins, Paul Rocchiccioli, Piotr Sonecki and many, many others). We contributed 83 out of 700 patients.

The Glasgow University heart failure team also had a major role in the Clinical Events Committee (Matt Lee, Kieran Docherty, Roy Gardner, Ninian Lang, Eugene Connolly, Pardeep Jhund). The clinical and research nursing teams at Golden Jubilee contributed hugely. The trial is a pivotal trial that demonstrated that stents did not reduce mortality or hospitalisations for heart failure in patients with heart failure.

Link to Paper

Background: Whether revascularization by percutaneous coronary intervention (PCI) can improve event-free survi bwval and left ventricular function in patients with severe ischemic left ventricular systolic dysfunction, as compared with optimal medical therapy (i.e., individually adjusted pharmacologic and device therapy for heart failure) alone, is unknown.

Methods: We randomly assigned patients with a left ventricular ejection fraction of 35% or less, extensive coronary artery disease amenable to PCI, and demonstrable myocardial viability to a strategy of either PCI plus optimal medical therapy (PCI group) or optimal medical therapy alone (optimal-medical-therapy group). The primary composite outcome was death from any cause or hospitalization for heart failure. Major secondary outcomes were left ventricular ejection fraction at 6 and 12 months and quality-of-life scores.

Results: A total of 700 patients underwent randomization - 347 were assigned to the PCI group and 353 to the optimal-medical-therapy group. Over a median of 41 months, a primary-outcome event occurred in 129 patients (37.2%) in the PCI group and in 134 patients (38.0%) in the optimal-medical-therapy group (hazard ratio, 0.99; 95% confidence interval [CI], 0.78 to 1.27; P = 0.96). The left ventricular ejection fraction was similar in the two groups at 6 months (mean difference, -1.6 percentage points; 95% CI, -3.7 to 0.5) and at 12 months (mean difference, 0.9 percentage points; 95% CI, -1.7 to 3.4). Quality-of-life scores at 6 and 12 months appeared to favor the PCI group, but the difference had diminished at 24 months.

Conclusions: Among patients with severe ischemic left ventricular systolic dysfunction who received optimal medical therapy, revascularization by PCI did not result in a lower incidence of death from any cause or hospitalization for heart failure. (Funded by the National Institute for Health and Care Research Health Technology Assessment Program; REVIVED-BCIS2 ClinicalTrials.gov number,

 


First published: 30 August 2022