Review Article
Volume 76, Issue 8, August 2020
JOURNAL：J Am Coll Cardiol.
Article Link
Raising the Evidentiary Bar for Guideline Recommendations for TAVR: JACC Review Topic of the Week
S Kaul.
KEYWORDS
clinical trials; guidelines; evidence;TAVR; SAVR
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.
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