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Timing of Intervention in Aortic Stenosis Aspirin with or without Clopidogrel after Transcatheter Aortic-Valve Implantation Long-Term Durability of Transcatheter Heart Valves: Insights From Bench Testing to 25 Years Transcatheter Aortic Valve Replacement in Low-risk Patients With Bicuspid Aortic Valve Stenosis Incidence and Outcomes of Surgical Bailout During TAVR : Insights From the STS/ACC TVT Registry Online Quantitative Aortographic Assessment of Aortic Regurgitation After TAVR: Results of the OVAL Study Safety and efficacy of a self-expanding versus a balloon-expandable bioprosthesis for transcatheter aortic valve replacement in patients with symptomatic severe aortic stenosis: a randomised non-inferiority trial Prior Balloon Valvuloplasty Versus Direct Transcatheter Aortic Valve Replacement: Results From the DIRECTAVI Trial Prevalence and Outcomes of Concomitant Aortic Stenosis and Cardiac Amyloidosis Association Between Diastolic Dysfunction and Health Status Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement
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Review ArticleVolume 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

ABSTRACT

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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