PARTNER A
Trial question
Is TAVR noninferior to SAVR in high-risk patients with severe aortic stenosis?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
43.0% female
57.0% male
N = 699
699 patients (298 female, 399 male).
Inclusion criteria: high-risk patients with severe aortic stenosis.
Key exclusion criteria: bicuspid or noncalcified valve, coronary artery disease requiring revascularization, LVEF < 20%, an aortic annulus diameter < 18 mm or > 25 mm, severe mitral or aortic regurgitation, recent neurologic event, and severe renal insufficiency.
Interventions
N=348 TAVR (with a balloon-expandable bovine pericardial valve, either a transfemoral or a transapical approach).
N=351 surgical AVR (surgical aortic-valve replacement).
Primary outcome
Death at 1 year
24.2%
26.8%
26.8 %
20.1 %
13.4 %
6.7 %
0.0 %
Transcatheter aortic valve
replacement
Surgical
AVR
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in death at 1 year (24.2% vs. 26.8%; MD -2.6, 95% CI -9.3 to 4.1).
Secondary outcomes
Borderline significant increase in major stroke, at 1 year (5.1% vs. 2.4%).
Significant increase in major vascular complications, at 30 days (11% vs. 3.2%; ARD 7.8, 95% CI 3.17 to 12.43).
Safety outcomes
Significant differences in at 30 days, major bleeding (9.3% vs. 19.5%, p < 0.001) and new-onset AF (8.6% vs. 16.0%, p = 0.006).
Conclusion
In high-risk patients with severe aortic stenosis, TAVR was noninferior to surgical AVR with respect to death at 1 year.
Reference
Smith CR, Leon MB, Mack MJ et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98.
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