SURTAVI
Trial question
Is TAVR noninferior to SAVR in patients with severe aortic stenosis who are at intermediate surgical risk?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
44.0% female
56.0% male
N = 1660
1660 patients (724 female, 936 male).
Inclusion criteria: patients with symptomatic, severe aortic stenosis who are at intermediate surgical risk.
Key exclusion criteria: refusal for SAVR as a treatment option, contraindication for placement of a bioprosthetic valve, known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, blood dyscrasias, ongoing sepsis, contraindication to extracorporeal assistance, cardiogenic shock or symptomatic carotid or vertebral artery disease.
Interventions
N=864 TAVR (with the use of a self-expanding bioprosthesis).
N=796 SAVR (surgical bioprosthesis).
Primary outcome
Death or disabling stroke at 24 months
12.6%
14%
14.0 %
10.5 %
7.0 %
3.5 %
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 (12.6% vs. 14%; ARD -1.4, 95% CI -5.2 to 2.3).
Secondary outcomes
No significant difference in death from any cause at 2 years (11.4% vs. 11.6%; ARD -0.2, 95% CI -3.8 to 3.3).
Safety outcomes
Significant differences in early (≤ 30 day) AKI stage 2 or 3, new or worsening AF, and the need for transfusion (more common in surgery group) and major vascular complications and the need for permanent pacemaker implantation (more common in TAVR group).
Conclusion
In patients with symptomatic, severe aortic stenosis who are at intermediate surgical risk, TAVR was noninferior to SAVR with respect to death or disabling stroke at 24 months.
Reference
Reardon MJ, Van Mieghem NM, Popma JJ et al. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2017 Apr 6;376(14):1321-1331.
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