PARTNER 3 (1-year follow-up)
Trial question
Is TAVR superior to SAVR in patients with severe aortic stenosis and low surgical risk?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
31.0% female
69.0% male
N = 950
950 patients (292 female, 658 male).
Inclusion criteria: patients with severe aortic stenosis at low risk of death with surgery.
Key exclusion criteria: clinical frailty; bicuspid aortic valves; other anatomical features increasing the risk of complications.
Interventions
N=496 TAVR (with a third-generation balloon-expandable valve).
N=454 SAVR (with a bioprosthetic valve).
Primary outcome
Death, stroke, or rehospitalization at 1 year
8.5%
15.1%
15.1 %
11.3 %
7.5 %
3.8 %
0.0 %
Transcatheter aortic valve
replacement
Surgical aortic valve
replacement
Significant
decrease ▼
NNT = 15
Significant decrease in death, stroke, or rehospitalization at 1 year (8.5% vs. 15.1%; HR 0.54, 95% CI 0.37 to 0.79).
Secondary outcomes
Significant decrease in stroke (0.6% vs. 2.4%; HR 0.25, 95% CI 0.07 to 0.88).
Significant decrease in death or stroke (1% vs. 3.3%; HR 0.3, 95% CI 0.11 to 0.83).
Significant decrease in new-onset AF (5% vs. 39.5%; HR 0.1, 95% CI 0.06 to 0.16).
Safety outcomes
No significant differences in safety endpoints at 30 days, including major vascular complications and new permanent pacemaker insertions.
Conclusion
In patients with severe aortic stenosis at low risk of death with surgery, TAVR was superior to SAVR with respect to death, stroke, or rehospitalization at 1 year.
Reference
Mack MJ, Leon MB, Thourani VH et al. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705.
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