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 risk for 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 John Forrest, MD, FACC, FSCAI.1 Limited randomized data exists comparing outcomes of TAVR to surgery in low surgical risk patients at time points beyond 2 years.
Dr. Forrest presented the 3-year clinical and echocardiographic outcomes from the Evolut Low Risk trial (NCT02701283) at the American College of Cardiology 2023 Annual Scientific Sessions. Participants 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 randomized to TAVR with a self-expanding, supra-annular valve (N=730) or surgery (N=684). Participants had a mean age of 74 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 (HR, 0.70; 95% CI, 0.49–1.00; P=0.051). At 30 days, the difference between treatment arms was already -1.8% (P=0.006), and this remained broadly consistent over time: -1.8% at year 1 (P=0.057); -2.0% at year 2 (P=0.084); and -2.9% at year 3 (P=0.051). All-cause mortality rates were 6.3% for TAVR and 8.3% for surgery (log-rank P=0.16). The respective percentages for disabling stroke were 2.3 and 3.4 (log-rank P=0.19).
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 the TAVR group. Rates of moderate or greater paravalvular regurgitation for both groups were <1%. The TAVR group showed significantly improved valve hemodynamics, with a mean gradient of 9.1 mmHg compared with 12.1 mmHg in the surgery group (P<0.001).
Dr. Forrest concluded, “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.”
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