Valvular & structural heart disease
Transcatheter aortic-valve replacement (TAVR) in Patients with Moderate Aortic Stenosis with At-Risk Features
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 −1.3Authors' 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
| Outcome | TAVR group | Clinical-surveillance group |
|---|---|---|
| Death from any cause · 2 years | 8.4% | 7.3% |
| Heart-failure event · 2 years | 10.8% | 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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