Percutaneous coronary intervention (PCI) does not reduce all-cause mortality or heart failure hospitalisation in patients with severe left ventricular dysfunction and extensive coronary artery disease, late-breaking research presented at the annual congress of the European Society of Cardiology (ESC 2022; 26–29 August, Barcelona, Spain) has shown.
This was the headline finding of REVIVED-BCIS2, a long-anticipated randomised trial of PCI versus optimal medical therapy for severe ischaemic cardiomyopathy. Results of the trial are intended to fill a gap in randomised evidence to determine the benefit of PCI in these patients.
Delivery of the primary endpoint elicited surprise among attendees to the hot line session at ESC 2022, with an audible intake of breath registering across the auditorium shortly after the data flashed on screen.
“Coronary artery disease is the most common cause of heart failure and for this reason it has long been assumed that treating the coronary artery disease would be a good treatment for heart failure,” REVIVED-BCIS2 investigator Divaka Perera (King’s College London, London, UK) commented in a press conference prior to the presentation of the full trial results at ESC 2022.
Despite there being no randomised evidence to support PCI in severe stable left ventricular function, the procedure is “frequently” performed in this context, Perera said, noting that it is indeed supported as a Class 2a recommendation within current European guidelines. Randomised data from the STICH trial support coronary artery bypass graft (CABG) surgery within this patient population.
REVIVED-BCIS2 is the first adequately powered randomised trial to examine the efficacy and safety of PCI in patients with left ventricular systolic dysfunction, enrolling patients with severe left ventricular dysfunction (ejection fraction ≤35%), extensive coronary artery disease and demonstrable viability in at least four dysfunctional myocardial segments that could be revascularised by PCI. Viability could be assessed by any modality, but cardiac magnetic resonance imaging was used most. Those with a myocardial infarction (MI) within four weeks, decompensated heart failure or sustained ventricular arrhythmias within 72 hours were excluded.
A total of 700 patients from 40 centres in the UK were randomly assigned in a 1:1 ratio to either PCI with optimal medical therapy or optimal medical therapy alone. The median age of participants was 70 years, 88% were men and the mean left ventricular ejection fraction was 27%. The primary outcome was the composite of all-cause death or hospitalisation for heart failure. Secondary outcomes included left ventricular ejection fraction at six and 12 months and quality of life measures.
Despite hypothesising that PCI would improve event-free surival within the patient population, Perera reported that, during a median follow up of 3.4 years, the primary outcome occurred in 129 (37.2%) patients in the PCI group and 134 (38%) patients in the medical therapy alone group for a hazard ratio (HR) of 0.99 (95% confidence interval 0.78–1.27, p=0.96).
“The key take home message from this where I am concerned is that this is now a definitive result, we finally have RCT [randomised controlled trial] evidence that allow guidelines to be strengthened on the one hand, and allow clinical practice to be rationalised around the world on the other,” Perera commented.
No significant difference was seen between groups in the major secondary outcome of the trial, left ventricular ejection fraction (LVEF) at six and 12 months. Given that only patients with demonstrable myocardial viability were enrolled, the latter finding challenges the concept of myocardial hibernation, which for decades has been considered an adaptation of the heart to cope with the effects of severe coronary disease, that can be reversed by treating the coronary disease.
Interestingly, according to Perera, quality of life (the other major secondary outcome) favoured PCI at six and 12 months but there was no difference between groups at 24 months. Asked about this in the press conference, Perera said that more data on this will feed into a health-economic analysis of the trial data.
Findings of the study were simultaneously published in the New England Journal of Medicine.