The randomized PARTNER 3, which initially showed TAVR superiority when using the SAPIEN 3 valve over SAVR in patients with severe aortic stenosis and low surgical risk, now presents its 7-year follow-up. The goal was to compare clinical and echocardiographic outcomes, and valve durability between the two strategies.
A total of 1000 patients were included (503 TAVR and 497 SAVR), mean age 73 and 1.9 % STS-PROM score. The primary endpoint was a composite of all-cause death, stroke, or rehospitalization (related to valve, procedure, or heart failure), assessed as time to first event, at 7 years.
At 7 years, the primary endpoint occurred in 22.7 % of the TAVR patients vs 27.3 % of SAVR patients (p = 0.01 for non-inferiority). There were no significant differences in the individual clinical endpoints: all-cause mortality was 14.2 % for TAVR vs 16.6 % for SAVR (p = 0.21), cardiovascular mortality 10.3 % vs 7.8 % (p = 0.27), stroke resulted similar between strategies, with 6.0 % vs 6.4 % (p = 0.72), as was valve, or cardiac failure related rehospitalization, with 10.7 % vs 7.5 % (p = 0.13). Neither were there differences in aortic reintervention rate (6.7 % vs 6.0 %; p = 0.69).
Echocardiographic analysis showed 11.6 mmHg mean aortic gradient for TAVR vs 13.7 mmHg for SAVR (p = 0.02), with 1.84 vs 1.93 cm² valve areas (p = 0.42), respectively. Valve durability using VARC-3 BVF criteria was excellent and comparable (6.9 % vs 7.3 %). ≥Mild paravalvular leak was more common after TAVR, with no impact on survival. Quality-of-life (KCCQ) and NYHA functional class showed similar and sustained improvement sustained over follow-up.
Conclusion
In conclusion, 7-year clinical, hemodynamic, and valve durability outcomes of severe AS patients at low surgical risk, treated with TAVR using the SAPIEN 3, resulted comparable to SAVR outcomes. These findings support the long-term safety and efficacy of TAVR and suggest its potential to become a definitive treatment option for increasingly younger patients with prolonged life expectancy.
Presented by Michael J. Mack, MD & Martin B. Leon, MD at TCT 2025 (Late-Breaking Clinical Trials), October 27, San Francisco, USA.
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