Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Dec 1;8(12):1154-1161.
doi: 10.1001/jamacardio.2023.3803.

Viability and Outcomes With Revascularization or Medical Therapy in Ischemic Ventricular Dysfunction: A Prespecified Secondary Analysis of the REVIVED-BCIS2 Trial

Divaka Perera  1   2 , Matthew Ryan  1 , Holly P Morgan  1 , John P Greenwood  3 , Mark C Petrie  4 , Matthew Dodd  5 , Roshan Weerackody  6 , Peter D O'Kane  7 , Pier Giorgio Masci  8 , Muhummad Sohaib Nazir  8   9 , Alexandros Papachristidis  1   10 , Navtej Chahal  11 , Rajdeep Khattar  9 , Saad M Ezad  1 , Stam Kapetanakis  2 , Lana J Dixon  12 , Kalpa De Silva  2   13 , Adam K McDiarmid  14 , Michael S Marber  1 , Theresa McDonagh  1   10 , Gerry P McCann  15 , Tim C Clayton  5 , Roxy Senior  9 , Amedeo Chiribiri  2   8 ; REVIVED-BCIS2 Investigators
Collaborators, Affiliations

Viability and Outcomes With Revascularization or Medical Therapy in Ischemic Ventricular Dysfunction: A Prespecified Secondary Analysis of the REVIVED-BCIS2 Trial

Divaka Perera et al. JAMA Cardiol. .

Abstract

Importance: In the Revascularization for Ischemic Ventricular Dysfunction (REVIVED-BCIS2) trial, percutaneous coronary intervention (PCI) did not improve outcomes for patients with ischemic left ventricular dysfunction. Whether myocardial viability testing had prognostic utility for these patients or identified a subpopulation who may benefit from PCI remained unclear.

Objective: To determine the effect of the extent of viable and nonviable myocardium on the effectiveness of PCI, prognosis, and improvement in left ventricular function.

Design, setting, and participants: Prospective open-label randomized clinical trial recruiting between August 28, 2013, and March 19, 2020, with a median follow-up of 3.4 years (IQR, 2.3-5.0 years). A total of 40 secondary and tertiary care centers in the United Kingdom were included. Of 700 randomly assigned patients, 610 with left ventricular ejection fraction less than or equal to 35%, extensive coronary artery disease, and evidence of viability in at least 4 myocardial segments that were dysfunctional at rest and who underwent blinded core laboratory viability characterization were included. Data analysis was conducted from March 31, 2022, to May 1, 2023.

Intervention: Percutaneous coronary intervention in addition to optimal medical therapy.

Main outcomes and measures: Blinded core laboratory analysis was performed of cardiac magnetic resonance imaging scans and dobutamine stress echocardiograms to quantify the extent of viable and nonviable myocardium, expressed as an absolute percentage of left ventricular mass. The primary outcome of this subgroup analysis was the composite of 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.

Results: The mean (SD) age of the participants was 69.3 (9.0) years. In the PCI group, 258 (87%) were male, and in the optimal medical therapy group, 277 (88%) were male. The primary outcome occurred in 107 of 295 participants assigned to PCI and 114 of 315 participants assigned to optimal medical therapy alone. There was no interaction between the extent of viable or nonviable 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 per 10% increase, 0.98; 95% CI, 0.93-1.04) or any secondary outcome. The extent of nonviable myocardium was associated with the primary outcome (hazard ratio, 1.07; 95% CI, 1.00-1.15), all-cause death, cardiovascular death, and improvement in left ventricular function.

Conclusions and relevance: This study found that viability testing does not identify patients with ischemic cardiomyopathy who benefit from PCI. The extent of nonviable myocardium, but not the extent of viable myocardium, is associated with event-free survival and likelihood of improvement of left ventricular function.

Trial registration: ClinicalTrials.gov Identifier: NCT01920048.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Dr Ryan reported receiving grants from the National Institute for Health Research (NIHR) and the British Heart Foundation during the conduct of the study. Mr Dodd reported receiving grants from NIHR during the conduct of the study. Dr O’Kane reported receiving personal fees from Abbott Vascular, Philips, Boston Scientific, Shockwave Medical, Vascular Perspective, Medtronic, and Terumo outside the submitted work. Dr Masci reported receiving personal fees from Perspectum Diagnostic outside the submitted work. Prof McCann reported receiving nonfinancial support from Circle CVI, grants from the British Heart Foundation, and grants from NIHR outside the submitted work. Prof Clayton reported receiving grants from NIHR during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. CONSORT Diagram Showing Flow of Participants Through the Study
CMR indicates cardiovascular magnetic resonance imaging; DSE, dobutamine stress echocardiography; OMT, optimal medical therapy; PCI, percutaneous coronary intervention; PET, positron emission tomography; and SPECT, single-photon emission computed tomography.
Figure 2.
Figure 2.. All-Cause Death or Hospitalization for Heart Failure (HHF) in Participants Assigned to Percutaneous Coronary Intervention (PCI) or Optimal Medical Therapy (OMT), Stratified by Viability Tertile
Kaplan-Meier estimates of the cumulative incidence of death from any cause of HHF in a time-to-first-event analysis, stratified by tertiles of the extent of myocardial viability. A, For the lower tertile, the extent of viability was less than or equal to 18%. B, For the middle tertile, the extent of viability was greater than 18% to less than or equal to 41%. C, For the upper tertile, the extent of viability was greater than 41%. HR indicates hazard ratio.
Figure 3.
Figure 3.. Association Between Viability Characteristics and Trial Outcomes
Forest plot of the hazard ratio (HR) (for clinical outcomes) or odds ratio (for improvement in left ventricular function) for the primary and secondary outcomes according to the extent of viable myocardium, extent of nonviable myocardium, and scar burden. Data relate to the whole trial population. Ratios are expressed per 10% absolute increase in the characteristic relative to overall left ventricular mass. The values relating to this graph are reported in eTable 5 in Supplement 2. HR indicates hazard ratio.
See this image and copyright information in PMC

Comment in

References

    1. Allman KC, Shaw LJ, Hachamovitch R, Udelson JE. Myocardial viability testing and impact of revascularization on prognosis in patients with coronary artery disease and left ventricular dysfunction: a meta-analysis. J Am Coll Cardiol. 2002;39(7):1151-1158. doi:10.1016/S0735-1097(02)01726-6 - DOI - PubMed
    1. Bonow RO, Maurer G, Lee KL, et al. ; STICH Trial Investigators . Myocardial viability and survival in ischemic left ventricular dysfunction. N Engl J Med. 2011;364(17):1617-1625. doi:10.1056/NEJMoa1100358 - DOI - PMC - PubMed
    1. Ling LF, Marwick TH, Flores DR, et al. . Identification of therapeutic benefit from revascularization in patients with left ventricular systolic dysfunction: inducible ischemia versus hibernating myocardium. Circ Cardiovasc Imaging. 2013;6(3):363-372. doi:10.1161/CIRCIMAGING.112.000138 - DOI - PubMed
    1. Ryan M, Morgan H, Chiribiri A, Nagel E, Cleland J, Perera D. Myocardial viability testing: all STICHed up, or about to be REVIVED? Eur Heart J. 2022;43(2):118-126. doi:10.1093/eurheartj/ehab729 - DOI - PMC - PubMed
    1. Perera D, Clayton T, Petrie MC, et al. ; REVIVED Investigators . Percutaneous revascularization for ischemic ventricular dysfunction: rationale and design of the REVIVED-BCIS2 trial. JACC Heart Fail. 2018;6(6):517-526. doi:10.1016/j.jchf.2018.01.024 - DOI - PubMed

Associated data