Valvular & structural heart disease

Transcatheter aortic-valve replacement (TAVR) in Patients with Moderate Aortic Stenosis with At-Risk Features

N Engl J MedPublished international, open-label, randomized trial

Primary result · Composite of death from any cause or a heart-failure event with or without hospitalizationResult — go to the resultRisk difference −7.2 percentage points 95% CI −13.1 to −1.3

Authors' conclusion

Among patients with moderate aortic stenosis and at-risk features, a strategy of TAVR was superior to clinical surveillance in lowering the incidence of death or a heart-failure event at 2 years. (Funded by Edwards Lifesciences; PROGRESS ClinicalTrials.gov number, NCT04889872.).

Study context

Population
Patients with moderate aortic stenosis with at least one at-risk feature (i.e., a symptom or structural or functional abnormality that has been shown to be associated with faster disease progression or adverse cardiovascular outcomes)underwent randomization
Participants
744 patients
Comparison
TAVR vs clinical surveillance
  • TAVR groupn = 373
  • Clinical-surveillance groupn = 371
Methodological details1:1 ratio
  • 1:1 ratio

Primary result

As reported in the abstract

Composite of death from any cause or a heart-failure event with or without hospitalization · 2 years

Risk difference

−7.2 percentage points

95% CI −13.1 to −1.3

P = 0.02 for superiority

By group

TAVR groupvs clinical-surveillance group
risk difference −7.2 percentage points (95% CI −13.1 to −1.3); P = 0.02 for superiority

Further findings

Kaplan-Meier estimate

OutcomeTAVR groupClinical-surveillance group
Death from any cause · 2 years8.4%7.3%
Heart-failure event · 2 years10.8%19.0%

Baseline characteristics

Mean age of patients
78 years
Women
39.1%
At low surgical risk
45.6%
Mean aortic-valve area
1.2 cm²
Mean aortic-valve peak velocity
3.3 m per second

Procedure-related adverse events

The incidence did not differ meaningfully between the patients in the TAVR group and those in the clinical-surveillance group who underwent aortic-valve replacement

Original publication

TAVR in Patients with Moderate Aortic Stenosis with At-Risk Features. N Engl J Med. Published 2 November 2026. doi:10.1056/nejmoa2607326

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