Evolut low risk
Trial question
Is TAVR noninferior to surgical AVR in low surgical risk patients with severe aortic stenosis?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 1403
1403 patients (490 female, 913 male)
Inclusion criteria: patients with severe aortic stenosis at low surgical risk
Key exclusion criteria: complex coronary artery disease, leukopenia, ventricular dysfunction, hemodynamic or respiratory instability, renal insufficiency, severe lung disease, active liver disease, severe pulmonary hypertension
Interventions
N=725 TAVR (with a self-expanding supraannular bioprosthesis)
N=678 SAVR (with a bioprosthetic valve)
Primary outcome
Death or disabling stroke at 24 months
5.3
6.7
6.7 %
5.0 %
3.4 %
1.7 %
0.0 %
Transcatheter aortic valve
replacement
Surgical aortic valve
replacement
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in death or disabling stroke at 24 months (5.3% vs. 6.7%; ARD -1.4, 95% CI -4.9 to 2.1)
Secondary outcomes
No significant difference in aortic valve gradient at 12 months (8.6 mmHg vs. 11.2 mmHg; ARD -2.6, 95% CI -3726.33 to 3721.13)
No significant difference in effective orifice areas at 12 months (2.3 cm² vs. 2 cm²; ARD 0.3, 95% CI -429.36 to 429.96)
Safety outcomes
No significant difference in secondary composite safety end point at 30 days (5.3% vs. 10.7%).
Conclusion
In patients with severe aortic stenosis at low surgical risk, TAVR was noninferior to SAVR with respect to death or disabling stroke at 24 months.
Reference
Popma JJ, Deeb GM, Yakubov SJ et al. Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1706-1715.
Open reference URL