In the REVIVED-BCIS2 trial, percutaneous coronary intervention (PCI) did not improve outcome in patients with ischaemic left ventricular dysfunction. It remained unclear whether myocardial viability testing has prognostic utility in these patients or identify a sub-population who may benefit from PCI.
To determine the impact of the extent of viable and non-viable myocardium on the effectiveness of PCI, prognosis and improvement in left ventricular function.
Prospective open-label randomized controlled trial recruiting between 2013 and 2020, median follow-up 3.4 years.
40 secondary and tertiary care centers in the United Kingdom from 2013 to 2020.
Of 700 randomized patients, 610 participants with left ventricular ejection fraction ≤35%, extensive coronary artery disease and evidence of viability in ≥ 4 segments that were dysfunctional at rest who underwent blinded core laboratory viability characterization.
Percutaneous coronary intervention (PCI) in addition to optimal medical therapy (OMT).
Main Outcomes and Measures
Blinded core laboratory analysis was performed of cardiac magnetic resonance scans and dobutamine stress echocardiograms to quantify the extent of viable and non-viable myocardium, expressed as an absolute percentage of left ventricular mass. The primary outcome was all-cause death or hospitalization for heart failure. Secondary outcomes were all-cause death, cardiovascular death, hospitalization for heart failure and improved left ventricular function at 6-months.
The primary outcome occurred in 107 of 295 participants assigned to PCI and 114 of 315 assigned to OMT alone. There was no interaction between the extent of viable or non-viable myocardium and the effect of PCI on the primary or any secondary outcome. Across the study population, the extent of viable myocardium was not associated with the primary outcome (hazard ratio [HR] 0·98 per 10% increase, 95% confidence interval [CI] 0·93 to 1·04) or any secondary outcome. The extent of non-viable myocardium was associated with the primary outcome (HR 1·07, CI 1·00 to 1·15), all-cause death, cardiovascular death and improvement in left ventricular function.
Conclusions and Relevance
Viability testing does not identify patients with ischemic cardiomyopathy who benefit from PCI. The extent of non-viability, but not the extent of viable myocardium, is associated with event-free survival and likelihood of improvement of left ventricular function.
ClinicalTrials.gov number, NCT01920048.
|Accepted/In press - 21 Aug 2023