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      Raising the Evidentiary Bar for Guideline Recommendations for TAVR

      Journal of the American College of Cardiology
      Elsevier BV

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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>

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          Author and article information

          Journal
          Journal of the American College of Cardiology
          Journal of the American College of Cardiology
          Elsevier BV
          07351097
          August 2020
          August 2020
          : 76
          : 8
          : 985-991
          Article
          10.1016/j.jacc.2020.05.085
          32819472
          b6393a13-7d9d-4d35-89e0-c1dade62af9e
          © 2020

          https://www.elsevier.com/tdm/userlicense/1.0/

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