CBS 2019
CBSMD教育中心
中 文

科学研究

Abstract

Recommended Article

Percutaneous Coronary Intervention for Vulnerable Coronary Atherosclerotic Plaque Risk Stratification in PAH Cardiovascular Magnetic Resonance as a complementary method to Transthoracic Echocardiography for Aortic Valve Area Estimation in patients with Aortic Stenosis: A systematic review and meta-analysis Comparison of the Efficacy and Safety Outcomes of Edoxaban in 8040 Women Versus 13 065 Men With Atrial Fibrillation in the ENGAGE AF-TIMI 48 Trial Cardiovascular Events Associated With SGLT-2 Inhibitors Versus Other Glucose-Lowering Drugs: The CVD-REAL 2 Study Quality of Life after Everolimus-Eluting Stents or Bypass Surgery for Treatment of Left Main Disease Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy Raising the Evidentiary Bar for Guideline Recommendations for TAVR: JACC Review Topic of the Week

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.