REVIVED

In Review

Perera D, et al. "Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction". NEJM. 2022. Epub 2022-08-27:1-10.
PubMed • Full text • PDF • ClinicalTrials.gov

Clinical Question

In patients with severe ischemic left ventricular systolic dysfunction, does revascularization by PCI reduce risk of death or hospitalization for heart failure?

Bottom Line

Revascularization by PCI did not significantly decrease the risk of death or hospitalization for heart failure compared to medical therapy in patients with left ventricular dysfunction.

Major Points

The Surgical Treatment for Ischemic Heart Failure (STITCH) trial evaluated CABG in addition to optimal medical therapy for stable coronary artery disease patients with severe left ventricular dysfunction. That trial didn't find significant improvement in the primary outcome of all-cause mortality at 4.7 years of follow-up, but did find improvement in all-cause mortality at 10 years.

The Revascularization for Ischemic Ventricular Dysfunction (REVIVED) trial, aimed to answer the question of whether percutaneous coronary intervention would also improve outcomes in patients with stable coronary artery disease with severe LV dysfunction. The trial did not find a difference in the primary outcome of death or hospitalization for heart failure over a median follow-up of 3.4 years (HR 0.99; 95% CI 0.78-1.27). There was also not found to be a significant improvement in LV ejection fraction.

The trial was limited by slow enrollment, which could have been due to selection bias in referrals to the trial. Since the comparator was optimal medical therapy and not CABG, many physicians may not have felt the trial reflected equipoise. Of note, most the patients had two vessel disease, potentially supporting the hypothesis that patients with more severe CAD were not referred for enrollment in the trial.

Guidelines

As of September 2022, no guidelines have been published that reflect the results of this trial.

Design

• Multicenter, open-label, randomized, controlled trial
• N=10,251
  • Intensive (n=347)
  • Standard (n=353)
• Setting: 40 centers in the United Kingdom
• Enrollment: August 2013 to March 2020
• Median follow-up: 41 months
• Analysis: Intention-to-treat
• Primary outcome: death or hospitalization for heart failure

Population

Inclusion Criteria

• Adults >/= 18 years
• Left ventricular ejection fraction of 35% or less
• Extensive CAD (British Cardiovascular Intervention Society jeopardy score of >/= 6)
• Viability in at least four dysfunctional myocardial segments

Exclusion Criteria

• Acute myocardial infarction in the four weeks prior to randomization
• Acute decompensated heart failure requiring inotropic support, invasive/noninvasive ventilation, or mechanical circulatory support in the 72 hours prior to randomization
• Sustained ventricular arrhythmia in the 72 hours prior to randomization
• Estimated glomerular filtration rate <25 ml/min
• Contraindications to PCI
• Valvular disease requiring imminent intervention
• life expectancy < 1 year due to non-cardiac reasons

Baseline Characteristics

For PCI group:

• Mean age: 70.0 years
• Male sex: 87%
• Race: 88%
  • White: 88%
  • Asian: 9%
  • Black: 1%
• Diabetes: 39%
• Previous myocardial infarction: 50%
• Previous PCI: 19%
• Previous CABG: 3%
• CCS angina class:
  • No angina: 66%
  • I or II: 32%
  • III: 2%
• Mean LVEF: 27.0%
• Median BCIS score: 10
• Coronary Artery Disease Characteristics:
  • Left main disease: 14%
  • 3-vessel disease: 38%
  • 2-vessel disease: 51%

Interventions

• Randomized to PCI plus medical therapy vs medical therapy alone
  • Medical therapy included heart failure pharmacologic therapy and device therapy
  • PCI revascularization to all disease proximal coronary vessels to viable myocardium
• Baseline echocardiography, as well as at 6-month and 12-month follow-up

Outcomes

Comparisons are PCI vs. medical therapy.

Primary Outcomes

Death from any cause or hospitalization for heart failure

37.2% vs. 38.0% (HR 0.99; 95% CI 0.78-1.27; P=0.96)

Secondary Outcomes

Death

31.7% vs. 32.6% (HR 0.98; 95% CI 0.75-1.27)

Hospitalization for heart failure

14.7% vs. 15.3% (HR 0.97; 95% CI 0.66-1.43)

Left ventricular ejection fraction change at 6 months

1.8% vs. 3.4% (mean difference, -1.6%; 95% CI -3.7 to 0.5)

Left ventricular ejection fraction change at 12 months

2.0% vs. 1.1% (mean difference 0.9%; 95% CI -1.7 to 3.4)

Criticisms

• Slow enrollment, lower than expected events compared to power calculations
• Lower severity of coronary artery disease

Funding

National Institute for Health and Care Research Health Technology Assessment Program