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Transcatheter Aortic-Valve Replacement in Low-Risk Patients at Five Years

Authors:
M.J. Mack, M.B. Leon, V.H. Thourani, P. Pibarot, R.T. Hahn, P. Genereux, S.K. Kodali, S.R. Kapadia, D.J. Cohen, S.J. Pocock, M. Lu, R. White, M. Szerlip, J. Ternacle, S.C. Malaisrie, H.C. Herrmann, W.Y. Szeto, M.J. Russo

Abstract

The PARTNER 3 trial randomized 1000 patients with severe, symptomatic aortic stenosis and low surgical risk to receive either transfemoral TAVR using the SAPIEN 3 valve or surgical aortic-valve replacement. Primary composite endpoint at 5 years: death, stroke, or rehospitalization occurred in 22.8% (TAVR) vs. 27.2% (surgery) (HR 0.79; 95% CI: 0.61–1.02; P=0.07)—not statistically significant. A second hierarchical composite endpoint (win ratio analysis) also showed no significant difference (Win ratio 1.17; 95% CI: 0.90–1.51; P=0.25). Individual outcomes at 5 years:

  • Death: 10.0% (TAVR) vs. 8.2% (surgery)

  • Stroke: 5.8% vs. 6.4%

  • Rehospitalization: 13.7% vs. 17.4%

  • Bioprosthetic valve failure: 3.3% (TAVR) vs. 3.8% (surgery)

  • Paravalvular regurgitation (mild+): 24.5% (TAVR) vs. 6.3% (surgery)

  • Valve thrombosis: 2.5% (TAVR) vs. 0.2% (surgery)

  • New-onset atrial fibrillation: 13.7% (TAVR) vs. 42.4% (surgery)

  • Pacemaker implantation: 13.5% (TAVR) vs. 10.4% (surgery)

  • Serious bleeding: 10.2% (TAVR) vs. 14.8% (surgery) Hemodynamic valve function and quality-of-life measures (KCCQ-OS ~86) remained stable and similar between groups.

The trial concludes TAVR and surgery show comparable 5-year outcomes in low-risk patients, with no significant difference in mortality or stroke. Durability and symptom relief were sustained across both modalities. Longer-term surveillance continues.

Keywords: ARTNER 3 trial aortic stenosis low-risk TAVR surgical valve replacement SAPIEN 3 valve bioprosthetic durability paravalvular regurgitation valve thrombosis stroke health status NYHA class KCCQ-OS
DOI: https://doi.ms/10.00420/ms/2008/FMCH5/KFY | Volume: 389 | Issue: 21 | Views: 0
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