Valvular & structural heart diseaseRandomised controlled trial
Early Surgery or Conservative Care for Asymptomatic Aortic Stenosis
- Randomised controlled trial
- multicentre
69 of 73 (95%) in Early surgery underwent surgery within 2 months after randomization
Authors' conclusion
Among asymptomatic patients with very severe aortic stenosis, the incidence of the composite of operative mortality or death from cardiovascular causes during the follow-up period was significantly lower among those who underwent early aortic-valve replacement surgery than among those who received conservative care.
Study context
- Population
- Asymptomatic patients with very severe AS (aortic-valve area ≤0.75 cm² with aortic jet velocity ≥4.5 m per second or mean transaortic gradient ≥50 mm Hg)
- Participants
- 145 patients
- Comparison
- Early surgery vs conservative care
- Early surgeryn = 73
- Conservative caren = 72reference
- Primary endpoint
- Operative mortality (death during or within 30 days after surgery) or CV death during entire follow-up
Primary result
As reported in the abstract
Hazard ratio
0.09
95% CI 0.01–0.67
P = 0.003
Events by treatment group
Early surgery vs Conservative care
HR 0.09 (95% CI 0.01–0.67); P = 0.003
Secondary outcomes
| Outcome | Early surgery | Conservative care | HR (95% CI) | |
|---|---|---|---|---|
| All-cause death during follow-up (major secondary end point) | 7% | 21% | 0.33 (0.12–0.90) | |
| 0.10.31310Hazard ratio (log scale) |
- Cumulative incidence of sudden death (Conservative care)
- 4% · 4 years · 8 years 14%
Operative mortality (Early surgery)
- No operative mortality in the early-surgery group; 69 of 73 (95%) underwent surgery within 2 months
Original publication
Early Surgery or Conservative Care for Asymptomatic Aortic Stenosis. N Engl J Med. Published 16 November 2019. doi:10.1056/nejmoa1912846
Summarised from the published abstract; every number is checked against it