Revascularization for Ischemic Ventricular Dysfunction - REVIVED-BCIS2

Mar 04, 2023
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, FACC
Trial Sponsor:
National Institute for Health and Care Research Health Technology Assessment Program
Date Presented:
03/04/2023
Date Published:
08/27/2022
Date Updated:
03/04/2023
Original Posted Date:
08/27/2022
References

Contribution To Literature:

Highlighted text has been updated as of March 4, 2023.

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) compared with optimal medical therapy 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 (n = 347) versus optimal medical therapy (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%

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 group compared with 38.0% of the optimal medical therapy group (p = 0.96). The findings were the same in all subgroups.

Secondary outcomes:

  • All-cause mortality: 31.7% of the PCI group compared with 32.6% of the optimal medical therapy group (p = not significant [NS])
  • Acute myocardial infarction: 10.7% of the PCI group compared with 10.8% of the optimal medical therapy group (p = NS)
  • LVEF at 12 months: mean difference, 0.9 percentage points (p = NS)

Left ventricular (LV) recovery by viability characterization:

  • All viable myocardium: odds ratio for LV recovery, 1.22 (95% confidence interval [CI] 1.08-1.37)
  • Dysfunctional, but viable myocardium: odds ratio for LV recovery, 1.01 (95% CI 0.93-1.11)
  • Scar burden: odds ratio for LV recovery, 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. Scar burden, but not viability characteristics at baseline, predicts 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:

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

Vergallo 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, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Cardiac Surgery and Heart Failure, Cardiac Surgery and SIHD, Acute Heart Failure, Interventions and Coronary Artery Disease

Keywords: ACC23, ACC Annual Scientific Session, ESC22, ESC Congress, Angina Pectoris, Cardiomyopathies, Coronary Artery Bypass, Coronary Artery Disease, Geriatrics, Heart Failure, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Percutaneous Coronary Intervention, Stroke Volume, Ventricular Dysfunction, Left, Ventricular Function, Left


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