Durable benefits of TAVR versus surgical aortic valve replacement in aortic stenosis patients

The 3-year results of the Evolut Low Risk trial demonstrated durable benefits of transcatheter aortic valve replacement (TAVR) compared with surgery among low-risk patients with aortic stenosis. The absolute difference remained consistent after 3 years, with a 30% relative reduction in the risk of death or disabling stroke.

TAVR has been FDA-approved for patients with aortic stenosis of all surgical risk levels since 2019 and has now surpassed surgical AVR (SAVR) in procedural volumes in the USA, said Prof. John Forrest (Yale Medicine, CT, USA) [1]. The 2-year outcomes of the randomised, multicentre Evolut Low Risk trial (NCT02701283) showed that TAVR for the treatment of severe symptomatic aortic stenosis in low-risk patients was non-inferior to surgery for the primary endpoint of all-cause death or disabling stroke [2]. Prof. Forrest presented the 3-year clinical and echocardiographic outcomes from the Evolut Low Risk trial.

The participants of the Evolut Low Risk trial had severe aortic stenosis with a low risk of death from surgery (>3%). Patients with bicuspid aortic valves were excluded. Between 2016 and 2019, 1,414 patients were randomised to TAVR with a self-expanding, supra-annular valve (n=730) or surgery (n=684). The participants had a mean age of 74 years and 35% were women.

At 3 years, the primary endpoint of all-cause mortality or disabling stroke had occurred in 7.4% of the TAVR group and 10.4% of the surgery group. At 30 days, the difference between treatment arms was already -1.8%, and this remained broadly consistent over time (see Figure). All-cause mortality was 6.3% for TAVR and 8.3% for surgery (P_log-rank=0.16). The respective percentages for disabling stroke were 2.3 and 3.4 (P_log-rank=0.19).

Figure: Primary endpoint of all-cause mortality or disabling stroke [1]

Mild paravalvular regurgitation (20.3% TAVR vs 2.5% surgery) and pacemaker placement (23.2% TAVR vs 9.1% surgery; P<0.001) were less frequent in the surgery group compared with TAVR. Rates of moderate or greater paravalvular regurgitation for both groups were <1%. The TAVR group showed significantly improved valve haemodynamics, with a mean gradient of 9.1 mmHg compared with 12.1 mmHg in the surgery group (P<0.001).

Prof. Forrest concluded that “the excellent valve performance and durable outcomes up to 3 years affirm the role of TAVR with the Evolut valve in this low-risk population.”

1. Forrest J, et al. Transcatheter versus surgical aortic valve replacement in aortic stenosis patients at low surgical risk: 3-year outcomes from the Evolut Low Risk trial. Session 405-14, ACC Scientific Session 2023, 4–6 March, New Orleans, USA.
2. Forrest JK, et al. J Am Coll Cardiol. 2022;79(9):882–896.

 

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Posted on 7 June, 2023