REVIVED-BCIS2 Trial Demonstrates PCI Does Not Benefit Patients With Severe Left Ventricular Dysfunction

August 27, 2022—Percutaneous coronary intervention (PCI) was found to not reduce all-cause mortality or heart failure hospitalization in patients with severe left ventricular dysfunction and extensive coronary artery disease in the REVIVED-BCIS2 trial. The study is the first adequately powered randomized trial to examine the efficacy and safety of PCI in patients with left ventricular systolic dysfunction, according to the European Society of Cardiology (ESC).

The trial’s chief investigator is Professor Divaka Perera, MD, of King’s College London, United Kingdom.

Prof. Perera commented in the ESC press release, “PCI provided no incremental benefit over optimal medical therapy in this high-risk population where approximately one in three patients died or were hospitalized with heart failure during follow-up.”

Prof. Perera stated further, “We can conclude that PCI should not be offered to stable patients with ischemic 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.

“These definitive results should help to rationalize 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.”

The late-breaking research was presented in a Hot Line session at the 2022 ESC Congress held August 26-29 in Barcelona, Spain.

The background of this study is that in the STICH trial, coronary artery bypass surgery (CABG) improved survival but only in highly selected—typically young—patients. Also, the benefit took 10 years to emerge, largely because of the early harm of the operation. Thus, PCI was an attractive alternative to CABG because it might offer the benefits of revascularization without the early hazard. However, there was no randomized evidence to support this, and guidelines recommending the use of this treatment in some patients were based only on expert opinion, noted the ESC press release.

According to the ESC press release, REVIVED-BCIS2 enrolled 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 revascularized by PCI. Any modality could assess viability, but cardiac MRI was used most. The study excluded patients with myocardial infarction within 4 weeks, decompensated heart failure, or sustained ventricular arrhythmias within 72 hours.

The trial was composed of 700 patients from 40 centers in the United Kingdom. Patients were randomly assigned in a 1:1 ratio to either PCI with optimal medical therapy or optimal medical therapy alone. The median age of patients was 70 years, 88% were men, and the mean left ventricular ejection fraction was 28%.

The trial’s primary outcome was the composite of all-cause death or hospitalization for heart failure. Secondary outcomes included left ventricular ejection fraction at 6 and 12 months and quality of life measures.

As summarized in the ESC press release, the investigators found the following results during a median follow-up of 3.4 years:

• The primary outcome occurred in 129 patients in the PCI group and 134 patients in the medical therapy alone group (37.2% vs 38%; hazard ratio, 0.99; 95% CI, 0.78-1.27; P = .96).
• No significant difference was seen between the groups in the trial’s major secondary outcome of left ventricular ejection fraction at 6 and 12 months.
• Quality of life (the other major secondary outcome) favored PCI at 6 and 12 months but there was no difference between groups at 24 months.

The press release advised that given that only patients with demonstrable myocardial viability were enrolled, the finding of no difference in left ventricular ejection fraction challenges the concept of myocardial hibernation. As noted in the press release, for decades this concept 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.