Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis - EARLY TAVR

Oct 28, 2024
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
Edwards Lifesciences
Date Presented:
10/28/2024
Date Published:
10/28/2024
Original Posted Date:
10/28/2024
References

Contribution To Literature:

The EARLY TAVR trial showed that TAVR for stage C aortic stenosis was beneficial compared with clinical surveillance.

Description:

The goal of the trial was to evaluate transcatheter aortic valve replacement (TAVR) compared with clinical surveillance among patients with asymptomatic severe aortic stenosis (stage C aortic stenosis).

Study Design

  • Randomized
  • Parallel

Patients with asymptomatic severe aortic stenosis (stage C aortic stenosis) were randomized to TAVR (n = 455) vs. clinical surveillance (n = 446).

  • Total number of enrollees: 901
  • Duration of follow-up: median 3.8 years
  • Mean patient age: 76 years
  • Percentage female: 29%
  • Percentage with diabetes: 26%

Inclusion criteria:

  • Patients ≥65 years of age with asymptomatic severe aortic stenosis
  • Negative exercise treadmill test

Exclusion criteria:

  • High-risk patients (Society of Thoracic Surgeons [STS] score >10%)
  • Left ventricular ejection fraction <50%
  • Any other class 1 indication for open heart surgery
  • Need for alternative access
  • Myocardial infarction within the last 30 days
  • Bicuspid aortic valve
  • Severe aortic regurgitation
  • Severe mitral regurgitation or moderate to severe mitral stenosis
  • Pre-existing mechanical or aortic valve in any position
  • Symptomatic carotid artery disease
  • Carotid revascularization within the last 30 days
  • Leukopenia, anemia, or thrombocytopenia
  • Hemodynamic or respiratory instability requiring mechanical support
  • Hypertrophic obstructive cardiomyopathy
  • Intracardiac mass, thrombus, or vegetation
  • Stroke or transient ischemic attack within the last 90 days
  • Severe pulmonary hypertension
  • Cirrhosis
  • Significant frailty
  • Refusal of blood products
  • BMI >50 kg/m2

Other salient features/characteristics:

  • STS risk of mortality: mean 1.8%
  • Asymptomatic status confirmed by exercise treadmill test: 91%
  • Bicuspid aortic valve: 8.1%
  • In the clinical surveillance group: 87% underwent aortic valve replacement during follow-up

Principal Findings:

The primary outcome, death, stroke, or unplanned hospitalization for cardiovascular causes, was 26.8% in the TAVR group vs. 45.3% in the clinical surveillance group (p < 0.001).

Secondary outcomes:

  • Death: 8.4% in the TAVR group vs. 9.2% in the clinical surveillance group
  • Stroke: 4.2% in the TAVR group vs. 6.7% in the clinical surveillance group
  • Unplanned hospitalization for cardiovascular cause: 20.9% in the TAVR group vs. 41.7% in the clinical surveillance group
  • Favorable outcome at 2 years, defined as being alive and Kansas City Cardiomyopathy Questionnaire (KCCQ) score ≥75 that had not decreased >10 points from baseline: 86.6% in the TAVR group vs. 68.0% in the clinical surveillance group (p < 0.001)

Interpretation:

Among patients with asymptomatic severe aortic stenosis (stage C aortic stenosis), early TAVR was beneficial. Early TAVR compared with clinical surveillance resulted in a lower incidence of the composite outcome of death, stroke, or unplanned hospitalization for cardiovascular cause. The individual components of the composite outcome all favored TAVR. In the clinical surveillance group, 87% underwent aortic valve replacement during follow-up. Therefore, in practicality, this trial compared a strategy of early TAVR vs. delayed TAVR. This trial will be used to inform future guideline recommendations regarding the management of stage C aortic stenosis.

References:

Généreux P, Schwartz A, Oldemeyer JB, et al., for the EARLY TAVR Trial Investigators. Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis. N Engl J Med 2024;Oct 28:[Epub ahead of print].

Presented by Dr. Philippe Généreux 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, Heart Valve Diseases, TCT24, Transcatheter Aortic Valve Replacement, Transcatheter Cardiovascular Therapeutics


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