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Abstract
<p class="first" id="d8942559e55">On August 16, 2019, the U.S. Food and Drug Administration
approved expanding the indication
for transcatheter aortic valve replacement (TAVR) to low-risk patients with symptomatic
severe aortic stenosis. The decision was based on the results of 2 pivotal trials
that confirmed superiority (PARTNER [Placement of Aortic Transcatheter Valves] 3)
or noninferiority (Evolut Low Risk [LR]) of TAVR as compared with SAVR at 1- and 2-year
follow-up, respectively. As compared with intermediate-risk cohorts, the sample size
in these trials was smaller and the total number of primary endpoint events was nearly
3 times as low (193 vs. 615). The total number of deaths from any cause or disabling
stroke at 1 year in the low-risk cohorts was 62, which is substantially lower than
the numbers in intermediate-, high-, and inoperable-risk cohorts. In Evolut LR, only
137 of 1,403 patients (9.8%) completed the 2-year follow-up, with 91.2% requiring
model-based imputation. Thus, the quantum of evidence is insufficient for endorsing
TAVR as the preferred intervention for these patients.
</p>