Percutaneous coronary intervention (PCI) does not reduce all-cause mortality or heart failure hospitalization in patients with severe left ventricular dysfunction and extensive coronary artery disease, according to state-of-the-art research presented at a session Hot Line today at the ESC 2022 Congress.
Coronary artery disease is the most common cause of heart failure and is associated with poor survival and poor quality of life despite advances in medical therapy. Treating the coronary arteries to improve blood supply (revascularization) has long been considered a treatment option in this population. In the STICH trial, coronary artery bypass surgery improved survival, but only in highly selected, usually young, patients. However, profit took 10 years to emerge, largely due to early damage from the operation. PCI was an attractive alternative to bypass surgery because it could offer the benefits of revascularization without the early danger. However, there were no randomized trials to support this and guidelines recommending the use of this treatment in some patients were based on expert opinion only.
REVIVED-BCIS2 is the first adequately powered randomized trial examining the efficacy and safety of PCI in patients with left ventricular systolic dysfunction. The trial enrolled patients with severe left ventricular dysfunction (ejection fraction of 35% or less), extensive coronary artery disease, and demonstrable viability in at least four dysfunctional myocardial segments that could be revascularized by PCI. Viability could be assessed by either modality, but cardiac MRI was most commonly used. Those with myocardial infarction within four weeks, decompensated heart failure or sustained ventricular arrhythmias within 72 hours were excluded.
A total of 700 patients from 40 UK centers were randomly assigned in a 1:1 ratio to PCI with optimal medical therapy or optimal medical therapy alone. The mean age of the participants was 70 years, 88% were men, and the mean left ventricular ejection fraction was 28%. The primary outcome was the composite of all-cause death or heart failure hospitalization. Secondary outcomes included left ventricular ejection fraction at six and 12 months and quality of life measures.
During a median follow-up of 3.4 years, the primary outcome occurred in 129 (37.2%) patients in the PCI group and 134 (38.0%) patients in the medical therapy alone group for a hazard ratio of 0.99 (95% confidence interval – 0.78). 1.27, p=0.96).
PCI provided no incremental benefit over optimal medical therapy in this high-risk population, where approximately one in three patients died or was hospitalized with heart failure during follow-up.”
Divaka Perera, Principal Researcher, Professor, King’s College London, UK
There was no significant difference between the groups in the primary secondary outcome of the trial, left ventricular ejection fraction at six and 12 months. Since only patients with demonstrable myocardial viability were enrolled, this latest 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 artery disease, which can be reversed by treating the coronary . illness
Quality of life (the other important secondary outcome) favored PCI at six and 12 months, but there was no difference between the groups at 24 months.
Professor Perera said: “We can conclude that PCI should not be offered to stable patients with ischemic left ventricular dysfunction if the sole aim is to provide a prognostic benefit. Our findings were consistent across all subgroups and for on all prespecified outcome measures. These definitive results should help rationalize guidelines on the management of coronary heart disease in patients with severely impaired left ventricular function. However, it is important to note that REVIVED-BCIS2 exclude patients with restrictive angina or recent acute coronary syndromes, and PCI is still an option in these settings.”
Source:
European Society of Cardiology (ESC)