Yesterday, Professor Divaka Perera (King’s College London - London, UK) presented results from the REVIVED-BCIS2 trial, which provides the first randomised data on the efficacy and safety of percutaneous coronary intervention (PCI) in ischaemic ventricular dysfunction.
Previously, in the STICH trial, coronary artery bypass surgery improved survival but only in highly selected, typically young, patients with ischaemic cardiomyopathy.1 Furthermore, the benefit took 10 years to emerge, largely due to the early harm of the operation. PCI was thought to be a more attractive alternative to bypass surgery, potentially offering the benefits of revascularisation without the early hazard; however, until now, randomised data were lacking.
To provide a conclusive answer, the UK-based REVIVED-BCIS2 trial enrolled 700 patients with severe left ventricular dysfunction (LVEF ≤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 most frequently used. Patients with a myocardial infarction within 4 weeks, decompensated heart failure (HF) or sustained ventricular arrhythmias within 72 hours were excluded.
A total of 700 patients were randomised 1:1 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 LVEF was 28%.
Over a median follow up of 3.4 years, the primary composite outcome – all-cause death or hospitalisation for HF – occurred in 37.2% of patients in the PCI group and 38.0% of patients in the medical therapy alone group (hazard ratio 0.99; 95% CI 0.78 to 1.27; p=0.96).
In addition, no significant difference was seen between the groups in the major secondary outcome of LVEF at 6 and 12 months. Given that only patients with demonstrable myocardial viability were enrolled, the lack of effect on LVEF now challenges the long-held concept of myocardial hibernation and reversible adaptation upon treatment.
The other major secondary outcome, quality of life, favoured PCI at 6 and 12 months, but there was no difference between groups at 24 months.
Summing up the evidence from the trial, Prof. Perera states: “PCI provided no incremental benefit over optimal medical therapy, in this high-risk population, where approximately one in three patients died or were hospitalised with HF during follow-up. We can conclude that PCI should not be offered to stable patients with ischaemic left ventricular dysfunction if the sole aim is to provide prognostic benefit. Our findings were consistent across all subgroups and for all prespecified outcome measures.” He ends by saying, “These definitive results should help to rationalise guidelines on managing coronary disease in patients with very poor left ventricular function. However, it is important to note that REVIVED-BCIS2 excluded patients with limiting angina or recent acute coronary syndromes, and PCI is still an option in these contexts.”