PARTNER 3 (5-year follow-up)
Trial question
What is the role of TAVR in low-risk patients with severe, symptomatic aortic stenosis?
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, symptomatic aortic stenosis at low surgical risk.
Key exclusion criteria: native aortic annulus size unsuitable for sizes 20, 23, 26, 29 mm transcatheter heart valve; evidence of acute MI ≤ 30 days before randomization; aortic valve unicuspid, bicuspid, or noncalcified; severe aortic regurgitation; complex coronary artery disease.
Interventions
N=496 TAVR (TAVR with a SAPIEN 3 valve).
N=454 surgery (SAVR with a commercially available bioprosthetic valve).
Primary outcome
Death, stroke, or rehospitalization related to valve, procedure, or heart failure at 5 years
22.8%
27.2%
27.2 %
20.4 %
13.6 %
6.8 %
0.0 %
Transcatheter aortic valve
replacement
Surgery
No significant
difference ↔
No significant difference in death, stroke, or rehospitalization related to the valve, procedure, or HF at 5 years (22.8% vs. 27.2%; HR 0.79, 95% CI 0.61 to 1.02).
Secondary outcomes
No significant difference in death, disabling stroke, nondisabling stroke, and rehospitalizations at 5 years (221% vs. 19%; WR 1.17, 95% CI 0.9 to 1.51).
No significant difference in death from any cause at 5 years (10% vs. 8.2%; HR 1.23, 95% CI 0.79 to 1.9).
No significant difference in stroke at 5 years (5.8% vs. 6.4%; HR 0.87, 95% CI 0.51 to 1.48).
Conclusion
In patients with severe, symptomatic aortic stenosis at low surgical risk, TAVR was not superior to surgery with respect to death, stroke, or rehospitalization related to the valve, procedure, or HF at 5 years.
Reference
Michael J Mack, Martin B Leon, Vinod H Thourani et al. Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years. N Engl J Med. 2023 Nov 23;389(21):1949-1960.
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