Why the study?
Following superior 1-year outcomes with TAVR versus surgery in low surgical risk patients with severe aortic stenosis, clinical and echocardiographic outcomes between 1 and 2 years required evaluation.
Does transfemoral TAVR with the SAPIEN 3 valve reduce the composite of death, stroke, or re-hospitalization compared to surgery in low surgical risk patients with symptomatic severe aortic stenosis?
Does transfemoral TAVR with the SAPIEN 3 valve reduce the composite of death, stroke, or re-hospitalization compared to surgery in low surgical risk patients with symptomatic severe aortic stenosis?
TAVR maintained superiority over surgery for the primary composite endpoint at 2 years in low-risk patients with severe aortic stenosis, though differences in death and stroke were no longer significant and valve thrombosis was higher with TAVR.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“[The study] provides robust, long-term evidence supporting the use of balloon-expandable TAVR in appropriately selected low-risk patients and reinforces the current guideline recommendations.”
Should not alter TAVR versus surgery choice outside trials; leaves open whether association is causal or due to unmeasured confounding.
BACKGROUND: In low surgical risk patients with symptomatic severe aortic stenosis, the PARTNER 3 (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis) trial demonstrated superiority of transcatheter aortic valve replacement (TAVR) versus surgery for the primary endpoint of death, stroke, or re-hospitalization at 1 year. OBJECTIVES: This study determined both clinical and echocardiographic outcomes between 1 and 2 years in the PARTNER 3 trial. METHODS: This study randomly assigned 1,000 patients (1:1) to transfemoral TAVR with the SAPIEN 3 valve versus surgery (mean Society of Thoracic Surgeons score: 1.9%; mean age: 73 years) with clinical and echocardiography follow-up at 30 days and at 1 and 2 years. This study assessed 2-year rates of the primary endpoint and several secondary endpoints (clinical, echocardiography, and quality-of-life measures) in this as-treated analysis. RESULTS: Primary endpoint follow-up at 2 years was available in 96.5% of patients. The 2-year primary endpoint was significantly reduced after TAVR versus surgery (11.5% vs. 17.4%; hazard ratio: 0.63; 95% confidence interval: 0.45 to 0.88; p = 0.007). Differences in death and stroke favoring TAVR at 1 year were not statistically significant at 2 years (death: TAVR 2.4% vs. surgery 3.2%; p = 0.47; stroke: TAVR 2.4% vs. surgery 3.6%; p = 0.28). Valve thrombosis at 2 years was increased after TAVR (2.6%; 13 events) compared with surgery (0.7%; 3 events; p = 0.02). Disease-specific health status continued to be better after TAVR versus surgery through 2 years. Echocardiographic findings, including hemodynamic valve deterioration and bioprosthetic valve failure, were similar for TAVR and surgery at 2 years. CONCLUSIONS: At 2 years, the primary endpoint remained significantly lower with TAVR versus surgery, but initial differences in death and stroke favoring TAVR were diminished and patients who underwent TAVR had increased valve thrombosis. (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis [PARTNER 3]; NCT02675114).
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Leon et al. (2021) studied this question.