Placement of Aortic Transcatheter Valves 2
Patients with severe symptomatic aortic stenosis and an STS-PROM score of 4-8%, indicating intermediate surgical risk, at 57 centers.
TAVR with the SAPIEN XT or SAPIEN 3 balloon-expandable valve
Surgical aortic valve replacement (SAVR)
Composite of death from any cause or disabling stroke at 2 years
The primary endpoint occurred in 19.3% of TAVR patients vs 21.1% of surgery patients at 2 years (p=0.25 for superiority; met noninferiority).
In the transfemoral-access cohort, TAVR was associated with lower rates of death or disabling stroke compared with surgery (16.8% vs 20.4%).
TAVR resulted in significantly lower rates of acute kidney injury (1.3% vs 3.1%), severe bleeding (10.4% vs 43.4%), and new-onset atrial fibrillation (9.1% vs 26.4%).
SAVR was associated with lower rates of major vascular complications (5.5% vs 7.9%) and paravalvular aortic regurgitation.
Hospital length of stay was significantly shorter with TAVR (6 vs 9 days).
The SAPIEN XT valve used in much of the trial has been superseded by the SAPIEN 3, which has lower paravalvular regurgitation rates.
Two-year follow-up may be insufficient to assess valve durability in a relatively younger intermediate-risk population.
The superiority endpoint was not met in the overall cohort, and the transfemoral subgroup benefit was a prespecified secondary analysis.
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