Revascularization for Ischemic Ventricular Dysfunction - REVIVED-BCIS2

Jan 03, 2024
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC; Kim A. Eagle, MD, MACC
Trial Sponsor:
National Institute for Health and Care Research Health Technology Assessment Program
Date Presented:
03/04/2023
Date Published:
10/25/2023
Date Updated:
01/03/2024
Original Posted Date:
08/27/2022
References

Contribution To Literature:

Highlighted text has been updated as of January 3, 2024.

The REVIVED-BCIS2 trial failed to show that multivessel PCI improved event-free survival and LVEF among patients with severe ischemic cardiomyopathy.

Description:

The goal of the trial was to evaluate percutaneous coronary intervention (PCI) plus optimal medical therapy compared with optimal medical therapy alone among individuals with left ventricular ejection fraction (LVEF) ≤35% and extensive coronary artery disease (CAD).

Study Design

  • Randomization
  • Parallel
  • Open-label

Patients with LVEF ≤35% and extensive CAD were randomized to multivessel PCI plus optimal medical therapy (n = 347) versus optimal medical therapy alone (n = 353).

  • Total number of enrollees: 700
  • Duration of follow-up: 3.4 years
  • Mean patient age: 70 years
  • Percentage female: 13%
  • Percentage with diabetes: 39%
  • Secondary prevention implantable cardioverter-defibrillator (ICD): 27%

Inclusion criteria:

  • LVEF ≤35%
  • Extensive CAD
  • Viability in ≥4 dysfunctional myocardial segments

Exclusion criteria:

  • Acute myocardial infarction within 4 weeks
  • Acute decompensated heart failure
  • Sustained ventricular arrhythmia within 72 hours

Principal Findings:

The primary outcome, all-cause mortality or hospitalization for heart failure, occurred in 37.2% of the PCI plus optimal medical therapy group compared with 38.0% of the optimal medical therapy alone group (p = 0.96). The findings were the same in all subgroups.

Secondary outcomes:

  • All-cause mortality: 31.7% of the PCI plus optimal medical therapy group compared with 32.6% of the optimal medical therapy alone group (p = not significant [NS])
  • Acute myocardial infarction: 10.7% of the PCI plus optimal medical therapy group compared with 10.8% of the optimal medical therapy alone group (p = NS)
  • LVEF at 12 months: mean difference, 0.9 percentage points (p = NS)
  • All-cause death or aborted sudden death: 41.6% in the PCI plus optimal medical therapy group vs. 40.2% in the optimal medical therapy alone group (p = 0.80)

Revascularization vs. medical therapy according to viability:

Viable myocardium:

  • Primary outcome, hazard ratio [HR] 0.98 (95% confidence interval [CI] 0.93-1.04)
  • Improved LV function, odds ratio [OR] 1.01 (95% CI 0.93-1.11)

Nonviable myocardium:

  • Primary outcome, HR 1.07 (95% CI 1.00-1.15)
  • Improved LV function, OR 0.82 (95% CI 0.73-0.93)

Scar:

  • Primary outcome, HR 1.18 (95% CI 1.04-1.33)
  • Improved LV function, OR 0.69 (95% CI 0.56-0.84)

Interpretation:

Among patients with LV systolic dysfunction and extensive CAD, multivessel PCI did not improve all-cause mortality or LV systolic function; however, there was no signal of harm from this approach. PCI also failed to reduce potentially fatal ventricular arrhythmias. Clinical outcomes were the same among those with viable and nonviable myocardium. Nonviable myocardium and scar burden predicted a lower likelihood of LV recovery. It remains possible that patients with the most severe CAD were referred for coronary artery bypass grafting.

The STICH trial found an association between coronary artery bypass graft surgery and improved survival among patients with LV systolic dysfunction and extensive CAD. Lack of benefit from PCI may have been due to less extensive CAD, fewer patients, and shorter follow-up.

References:

Perera D, Ryan M, Morgan HP, et al. Viability and Outcomes With Revascularization or Medical Therapy in Ischemic Ventricular Dysfunction: A Prespecified Secondary Analysis of the REVIVED-BCIS2 Trial. JAMA Cardiol 2023;8:1154-61.

Perera D, Morgan HP, Ryan M, et al., on behalf of the REVIVED-BCIS2 Investigators. Arrhythmia and Death Following Percutaneous Revascularization in Ischemic Left Ventricular Dysfunction: Prespecified Analyses From the REVIVED-BCIS2 Trial. Circulation 2023;148:862-71.

Presented by Dr. Divaka Perera at the American College of Cardiology Annual Scientific Session (ACC.23/WCC), New Orleans, LA, March 4, 2023.

Verga R, Liuzzo G. The REVIVED-BCIS2 trial: percutaneous coronary intervention vs. optimal medical therapy for stable patients with severe ischemic cardiomyopathy. Eur Heart J 2022;43:4775-6.

Perera D, Clayton T, O’Kane PD, et al., on behalf of the REVIVED-BCIS2 Investigators. Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction. N Engl J Med 2022;387:1351-60.

Editorial: Kirtane AJ. REVIVE-ing a Weak Heart — Details Matter. N Engl J Med 2022;387:1426-7.

Presented by Dr. Divaka Perera at the European Society of Cardiology Congress (ESC 2022), Barcelona, Spain, August 27, 2022.

Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Aortic Surgery, Cardiac Surgery and Heart Failure, Acute Heart Failure

Keywords: ACC23, ESC22, Heart Failure, Myocardial Revascularization, Percutaneous Coronary Intervention, Ventricular Dysfunction, Left


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