Percutaneous coronary intervention (PCI) plus optimal medical therapy (OMT) did not lower all-cause mortality or heart failure hospitalization compared to OMT alone in patients with severe ischemic left ventricular (LV) systolic dysfunction, new trial results show.
Divaka Perera, MD, of King’s College, London, reported these findings from the REVIVED-BCIS2 trial Saturday at the European Society of Cardiology (ESC) Congress 2022 in Barcelona, Spain. They were also simultaneously published online in The New England Journal of Medicine.
Perera pointed out that PCI is frequently used to treat severe stable LV systolic dysfunction even though there had previously been no randomized-trial evidence to support this. The ESC guidelines, he added, list PCI as a class 2a, level of evidence C indication for this condition.
REVIVED-BCIS2, Perera said, is the first randomized controlled trial in this area and shows that PCI does not reduce all-cause death or hospitalization at a median follow-up of 3.4 years.
Inclusion criteria included patients with left ventricular ejection fraction (LVEF) ≤35% and extensive coronary disease (signified by British Cardiovascular Intervention Society myocardial jeopardy score [BCIS-JS] ≥6). They also had to have viable myocardium as shown by non-invasive imaging and be able to undergo PCI to lesions subtending to ≥4 dysfunctional but viable segments.
Echocardiography was performed at 6- and 12-month follow-up, and echocardiographers were blinded to the patient’s treatment assignment.
The primary outcome was a composite of all-cause mortality or heart failure hospitalization at a minimum follow-up of 24 months. Key secondary outcomes included LVEF at 6 and 12 months and quality-of-life scores.
At a median follow-up of 41 months, a primary-outcome event occurred in 129 of 347 patients (37.2%) in the PCI group and in 134 of 353 patients (38%) in the OMT group (hazard ratio [HR]: 0.99; 95% confidence interval [CI]: 0.78 to 1.27; p=0.96).
The change in LVEF from baseline was 1.8 percentage points at 6 months and 2 percentage points at 12 months in the PCI group, and the change was 3.4 percentage points at 6 months and 1.1 percentage points at 12 months in the OMT group. LVEF was similar between the groups at 6 months (mean difference: -1.6 percentage points; 95% CI: -3.7 to 0.5) and 12 months (mean difference: 0.9 percentage points; 95% CI: -1.7 to 3.4).
Kansas City Cardiomyopathy Questionnaire score did appear to be higher in the PCI group at 6 months (mean difference: 6.5 points; 95% CI: 3.5 to 9.5) and 12 months (mean difference: 4.5 points; 95% CI: 1.4 to 7.7), but the PCI group’s scores flattened while the OMT group’s scores increased, whittling the mean difference to 2.6 points in favor of PCI at 2 years (95% CI: -0.7 to 5.8).
In an accompanying editorial, Ajay J. Kirtane, MD, of Columbia University Irving Medical Center, New York-Presbyterian Hospital and the Cardiovascular Research Foundation, raised several questions about the study. He wrote that investigators should describe the anatomical location and extent of coronary artery disease and its correlation with physiological – and especially ischemic – testing in more detail. Was the extent and degree of cardiomyopathy explained by the observed coronary artery disease?
“Despite considerable ventricular dysfunction, approximately half the patients had only two-vessel disease, and a median of two lesions and vessels were treated per patient,” he wrote. “This relatively modest degree of coronary artery disease seems unusual for patients selected to undergo revascularization with the hope of restoring or normalizing ventricular function.”
When asked about this during a press conference announcing the results, Perera said he disagreed with the characterization that the patients’ coronary artery disease was “relatively modest.”
“It was for the very reason that we believed as a group of investigators the two- or three-vessel disease classification to be suboptimal that we devised the BCIS jeopardy score 10 or 12 years ago, which gives you much more granularity,” he said.
The patients’ median BCIS-JS was 10, which Perera said was “pretty high.” He noted that a BCIS-JS of 12 means the entire myocardium is perfused by severely diseased coronary arteries. He added that unlike several other trials comparing PCI to OMT alone, REVIVED-BCIS2 did not exclude patients with left main disease.
Perera did agree, however, with Kirtane’s point that more details on the type of revascularization and how that relates to whether the myocardium seemed to be viable. He said more information would be forthcoming as analysis of the study’s data continues.
The REVIVED-BCIS2 trial was funded by the U.K. National Institute for Health and Care Research Health Technology Assessment Program.