Early Valve Replacement Guided by Biomarkers of Left Ventricular Decompensation in Asymptomatic Patients With Severe Aortic Stenosis - EVOLVED

Oct 28, 2024
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
Sir Jules Thorne Charitable Trust
Date Presented:
10/28/2024
Date Published:
10/28/2024
Original Posted Date:
10/28/2024
References

Contribution To Literature:

Early aortic valve intervention with SAVR/TAVR among patients with asymptomatic aortic stenosis, normal EF, and with evidence of LGE on CMR did not improve the primary composite endpoint of all-cause mortality or unplanned aortic stenosis-related hospitalization.

Description:

The goal of the trial was to assess the safety and efficacy of early aortic valve replacement compared with conservative management among patients with asymptomatic severe aortic stenosis, normal ejection fraction (EF), and presence of myocardial fibrosis on cardiac magnetic resonance imaging (CMR).

Study Design

Eligible patients were randomized in a 1:1 open-label fashion to early valve intervention with either surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) (n = 113) or conservative management (n = 111).

  • Total screened: 427
  • Total number of enrollees: 224
  • Duration of follow-up: 42 months
  • Median patient age: 75.5 years
  • Percentage female: 28%

Inclusion criteria:

  • Age ≥18 years
  • Severe asymptomatic stenosis
  • Asymptomatic per attending physician
  • Midwall late gadolinium enhancement (LGE) on CMR

Exclusion criteria:

  • Left ventricular ejection fraction (LVEF) <50%
  • Concomitant severe aortic or mitral regurgitation
  • Estimated glomerular filtration rate <30 mL/min/1.73 m2
  • Contraindications to magnetic resonance imaging (MRI)
  • Deemed unfit for surgery or TAVR

Other salient features/characteristics:

  • Cardiovascular disease: 10%
  • History of angina: 6%
  • Presence of LV hypertrophy on ECG: 78%
  • Bicuspid valve on CMR: 28%
  • LVEF on CMR: 68%
  • Median time to intervention for early intervention vs. conservative management: 5.0 vs. 20.2 months

Principal Findings:

The primary endpoint (all-cause death or unplanned aortic stenosis hospitalization) for early intervention vs. conservative management, was: 18% vs. 23% (hazard ratio [HR] 0.79, 95% confidence interval [CI] 0.44-1.43, p = 0.44).

  • All-cause mortality: 14% vs. 13% (p > 0.05)
  • Unplanned aortic stenosis-related hospitalization: 6% vs. 17% (HR 0.37, 95% CI 0.16-0.88)

Secondary outcomes for early intervention vs. conservative management:

  • Cardiovascular mortality: 9% vs. 7% (p > 0.05)
  • Stroke: 7% vs. 13% (p > 0.05)
  • New York Heart Association (NYHA) class I: 80% vs. 62% (odds ratio 0.37, 95% CI 0.20-0.70)

Interpretation:

The results of this trial indicate that early aortic valve intervention with SAVR/TAVR among patients with asymptomatic aortic stenosis, normal EF, and with evidence of LGE on CMR did not improve the primary composite endpoint of all-cause mortality or unplanned aortic stenosis-related hospitalization over a median duration of 42 months. There was, however, an improvement in aortic stenosis-related hospitalization and NYHA class but these have to be considered in the context of an overall negative trial.

These are interesting findings. One caveat is that asymptomatic status was based on physician assessment and an exercise test was not mandated. The sample size was also small, and the majority of patients received SAVR. The larger EARLY TAVR trial noted a benefit with early TAVR among asymptomatic patients with severe aortic stenosis (patients were enrolled based on normal stress test, not MRI findings). In this trial, the population for increased cardiac risk was enriched by using cardiac biomarkers and CMR, and a patient population was selected with aortic stenosis in whom the left ventricle was starting to decompensate due to their severe valve disease by means of mid-wall LGE detection on CMR. It remains an interesting hypothesis for risk stratification and it is unclear if a larger trial with lower procedural mortality (for instance, with TAVR) may show different results.

References:

Loganath K, Craig NJ, Everett RJ, et al., for the EVOLVED Investigators. Early Intervention in Patients With Asymptomatic Severe Aortic Stenosis and Myocardial Fibrosis: The EVOLVED Randomized Clinical Trial. JAMA 2024;Oct 28:[Epub ahead of print].

Editorial: Bonow RO. Myocardial Fibrosis and Timing of Intervention for Aortic Stenosis. JAMA 2024;Oct 28:[Epub ahead of print].

Presented by Dr. Mark R. Dweck at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2024), Washington, DC, October 28, 2024.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease

Keywords: Aortic Valve Stenosis, TCT24, Transcatheter Aortic Valve Replacement, Transcatheter Cardiovascular Therapeutics


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