Evolut Low Risk Trial: TAVI Matches Surgery at 5 Years for Low-Risk Patients With Aortic Stenosis

 At the ACC 2025 Scientific Session, 5-year results from the Evolut Low Risk trial confirmed what many clinicians hoped: transcatheter aortic valve implantation (TAVI) continues to perform on par with surgery in low-risk patients with severe aortic stenosis. The trial results, also published in the Journal of the American College of Cardiology (JACC), offer long-term reassurance for a younger, healthier patient group.

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Study Overview

• Trial: Evolut Low Risk

• Design: International, multicenter, randomized controlled trial

• Sites: 86 locations in Australia, Canada, France, Japan, Netherlands, New Zealand, and the US

• Participants: 1,414 patients with severe aortic stenosis and low surgical risk

  • Mean age: 74 years

  • 35% women

  • STS score: ~2%

• Intervention:

  • TAVI Group: CoreValve, Evolut R, or Evolut PRO (n = 730)

  • SAVR Group: Surgical aortic valve replacement with bioprosthetic valve (n = 684)

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Inclusion Criteria

• Diagnosed with severe aortic stenosis

• Low predicted surgical mortality risk (<3%)

• Eligible for both TAVI and SAVR based on heart team assessment

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Exclusion Criteria

• Bicuspid aortic valve

• Inadequate femoral access

• Active endocarditis or bleeding disorders

• Previous valve surgery or TAVI

• Life expectancy <1 year

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Key 5-Year Outcomes

Primary Endpoint: All-cause mortality or disabling stroke

• TAVI: 15.5%

• SAVR: 16.4%

• P = 0.47 → No significant difference

Cardiovascular mortality

• TAVI: 7.2%

• SAVR: 9.3%

• P = 0.15

Disabling stroke

• TAVI: 3.6%

• SAVR: 4.0%

• P = 0.57

KCCQ Health Status (quality of life)

• Kansas City Cardiomyopathy Questionnaire:

  • Similar between groups (~70% with scores >75)

  • TAVI group showed earlier improvement (as early as 30 days)

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Valve Function & Complications

• Echocardiographic performance favored TAVI:

  • Lower mean aortic valve gradient

  • Larger effective orifice area

• Paravalvular regurgitation (mild or greater):

  • TAVI: 17.0%

  • SAVR: 5.7%

  • P < 0.001

• Pacemaker implantation by 5 years:

  • TAVI: 27%

  • SAVR: 11.3%

  • P < 0.001

• Valve reintervention:

  • Similar in both groups (3.3% vs. 2.5%, P = 0.44)

• Valve thrombosis (clinical or subclinical):

  • Rare and not different between groups

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Durability & Surveillance

While TAVI performed impressively through 5 years, researchers emphasized the importance of ongoing follow-up through 10 years to confirm valve durability, especially in younger patients. Recommendations include:

• Annual echocardiographic surveillance

• Continued study of technique improvements (e.g., cusp overlap technique) to reduce pacemaker rates

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Take-Home Points

• TAVI is noninferior to SAVR at 5 years in low-risk patients with severe aortic stenosis

• Mortality and disabling stroke rates are similar between groups

• TAVI patients feel better sooner, with earlier improvements in quality of life

• Pacemaker requirement remains higher after TAVI—but without impacting long-term survival

• Paravalvular leak remains more frequent with TAVI, but procedural refinements continue to address this

• TAVI continues to evolve into a safer, more predictable procedure with excellent midterm outcomes

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For patients and clinicians wondering "Can TAVI hold up over time?"—this trial answers with a confident yes—at least for five years. The future looks increasingly favorable for less invasive solutions to aortic stenosis.