Heart failure

PCI has no benefit in patients with severe LV dysfunction: REVIVED-BCIS2

PCI should not be offered to stable patients with low left ventricular ejection fraction and viable myocardium because it does not reduce mortality or heart failure hospitalisation, researchers told delegates at the ESC Congress 2022.

While PCI has previously been suggested as an alternative to coronary artery bypass surgery, there is no randomised evidence to support this and guidelines supporting this approach have been based only on expert opinion, the meeting heard.

UK investigators therefore conducted a randomised trial  – the REVIVED-BCIS2 study – to examine the efficacy and safety of PCI in patients with severe left ventricular dysfunction (ejection fraction 35% or below), extensive coronary artery disease and demonstrable viability in at least four dysfunctional myocardial segments that could be revascularised by PCI.

The study enrolled 700 patients from 40 centres in the UK, who were randomly assigned 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 28%.

During a median follow up of 3.4 years, the primary outcome (a composite of all-cause death or hospitalisation for heart failure) occurred in 37.2% of patients in the PCI group and 38.0% of patients in the control group, for a hazard ratio of 0.99.

Similarly, no significant difference was seen for secondary outcomes including left ventricular ejection fraction at six and 12 months and quality of life measures.

Chief Investigator Professor Divaka Perera of King’s College London, said the trial only enrolled patients with demonstrable myocardial viability, and therefore the findings challenged the concept of ‘myocardial hibernation’, which 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.

“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 heart failure during follow-up,” he said.

“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,” he added.

The investigators said the findings were consistent across all subgroups and for all prespecified outcome measures.

“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,” said Prof. Perera.

The findings were published simultaneously in the NEJM (link), in which an accompanying commentary stated that the trial left many questions unanswered. It pointed to the modest degree of coronary artery disease seen in many trial participants, which seemed unusual for patients selected to undergo revascularization with the hope of restoring or normalizing ventricular function.

“Furthermore, no descriptions of the severity of stenosis, physiological assessment of the lesion, or, most importantly, correlation of stenosis with previous ischemic or viability testing are provided. For clinicians taking care of patients with left ventricular dysfunction, these details matter,” it said.

“It is also probable, given the previously observed mortality benefit seen in the STICH trial, that patients with the most extensive and severe coronary artery disease were offered surgical revascularisation outside the trial rather than being enrolled, a factor that could dilute a treatment effect,” the authors said.

“More than anything, this trial supports the importance of guideline-directed medical therapies for the management of left ventricular dysfunction, irrespective of whether revascularisation is considered,” the commentary concluded.

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