No Such Thing as Too Early For TAVI in Asymptomatic Severe Aortic Stenosis

Feb 18, 2025   |  Xuan Yao, MD; Hooman Bakhshi, MD, FACC; Dr. Sumon Roy, MD, MSc, FACC

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The EARLY TAVR (Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis) trial results demonstrate that early transcatheter aortic valve implantation (TAVI) in patients with asymptomatic severe aortic stenosis (AS) is superior to clinical surveillance in significantly reducing the composite primary outcome of death, stroke, or unplanned hospitalization for cardiovascular (CV) causes.1

The EARLY TAVR trial was a multicenter randomized trial comparing early transfemoral balloon-expandable TAVI with continued clinical surveillance in 901 patients with asymptomatic severe AS and preserved left ventricular ejection fraction.1 Asymptomatic status with treadmill stress testing was confirmed in 91% of patients. At a median follow-up of 3.8 years, the aforementioned composite primary outcome was significantly reduced with early TAVI compared with surveillance (26.8% vs. 45.3%; hazard ratio, 0.5; confidence interval, 0.4-0.63; p < 0.001) driven largely by unplanned hospitalization from CV causes (20.9% vs. 41.7%). The rate of death with early TAVI was 8.4% and with continued surveillance was 9.2%; the rate of stroke with early TAVI was 4.2% and with continued surveillance was 6.7%. Procedure-related adverse event rates were similar between the two groups.

These trial data are the first suggesting consideration of TAVI in asymptomatic severe AS is indicated before the onset of clinical decline associated with progression of valvular dysfunction. These findings align with recent reports indicating early surgical aortic valve replacement (SAVR) in a similar subset of patients may improve outcomes.2,3 Limitations of the EARLY TAVR trial included no blinding and lack of a SAVR arm.

References

  1. Généreux P, Schwartz A, Oldemeyer J, et al.; EARLY TAVR Trial Investigators. Transcatheter aortic-valve replacement for asymptomatic severe aortic stenosis. N Engl J Med 2024;Oct 28:[ePub ahead of print].
  2. Banovic M, Putnik S, Penicka M, et al.; AVATAR Trial Investigators. Aortic valve replacement versus conservative treatment in asymptomatic severe aortic stenosis: the AVATAR trial. Circulation 2022;145:e658-e658.
  3. Kang DH, Park SJ, Lee SA, et al. Early surgery or conservative care for asymptomatic aortic stenosis. N Engl J Med 2020;382:e111-e119.

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

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