TCT has presented the 5-year clinical and echocardiographic outcomes of low-risk patients with severe aortic stenosis treated with transcatheter aortic valve replacement (TAVR) using balloon-expandable Sapien valves vs. surgical aortic valve replacement (SAVR).
The first primary end point was a non-hierarchical composite of all-cause mortality stroke or rehospitalization. The second was a hierarchical composite including all-cause mortality, disabling and non-disabling stroke and rehospitalization.
When looking at the first primary end point vs SAVR patients, we observe a 21% reduction in events rate (HR at 5 years = 0.79 [CI 95% 0.61-1.02]; p=0.07). On the other hand, the second primary end point using the WinRatio showed a higher number of events in TAVR patients, with 1.17 (CI 95%, 0.90-1.51; p=0.25).
When looking at specific subgroups, we find smaller valves, such as # 26 and 23 (vs # 29), presented lower events rate, with 5-year HR 0.81 [CI 95% 0.51-1.29]; p=0.62. Also, valve area and valve failure rates were similar in both groups, with 5-year HR 0.86 [CI 95% 0.42-1.77]; p=0.69.
Read also: TCT 2023 | ALIGN AR Trial.
There were no significant differences between treatments when looking at quality of life, measured by KCCQ score >75 (71% vs. 71.9%), nor in valve durability, defined as the absence of failure (86.3% vs. 87.4%).
In sum, patients with severe aortic stenosis at low risk treated with Sapien-3 TAVR or SAVR showed similar rates and low numbers of clinical events. The differences in primary end point that initially had favored TAVR at one year, were attenuated after 5 years (from 7.1% to 4.3%). Both valve failure and valve deterioration saw low frequency with both treatments.
Dr. Omar Tupayachi.
Member of the Editorial Board of SOLACI.org.
Presented by Martin B. Leon as part of the Late-Breaking Clinical Trials at TCT 2023, San Francisco, October 24, 2023.
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