Takeaway
- In asymptomatic aortic stenosis (AAS), early valve replacement bested conservative management for cardiovascular mortality in this trial in Korea.
Why this matters
- Whether to operate early or wait has been controversial in AAS cases.
- Replacement is ultimately the sole effective therapy, but how the risks of surgery-related mortality balanced against mortality risks from waiting was unclear.
- The timing and indications for surgical intervention in asymptomatic patients with severe aortic stenosis remain controversial.
Key results
- There were no surgery-related deaths.
- In intention-to-treat analysis, 1% in the surgery group had primary endpoint (composite of operative and cardiovascular mortality).
- 15% had the primary endpoint in the conservative management group.
- The HR for mortality with conservative management was 0.09 (95% CI, 0.01-0.67; P=.003).
- The number needed to treat to prevent 1 cardiovascular death in 4 years was 20.
- With conservative management, the sudden death cumulative incidence was 4% at 4 years and 14% at 8 years.
- Hospitalisation for heart failure was also lower with surgical vs conservative management (0% vs 11%).
Study design
- Multicentre randomised trial of 145 patients (surgery, 73; conservative care, 72) with AAS (but stenosis was “very severe").
- Funding: Korean Institute of Medicine.
Limitations
- The severity of the stenosis in this study might preclude generalising to less severe cases.
References
References