Outcomes 2 Years After Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk

Abstract

Background: In low surgical risk patients with symptomatic severe aortic stenosis, the PARTNER 3 (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis) trial demonstrated superiority of transcatheter aortic valve replacement (TAVR) versus surgery for the primary endpoint of death, stroke, or re-hospitalization at 1 year.

Objectives: This study determined both clinical and echocardiographic outcomes between 1 and 2 years in the PARTNER 3 trial.

Methods: This study randomly assigned 1,000 patients (1:1) to transfemoral TAVR with the SAPIEN 3 valve versus surgery (mean Society of Thoracic Surgeons score: 1.9%; mean age: 73 years) with clinical and echocardiography follow-up at 30 days and at 1 and 2 years. This study assessed 2-year rates of the primary endpoint and several secondary endpoints (clinical, echocardiography, and quality-of-life measures) in this as-treated analysis.

Results: Primary endpoint follow-up at 2 years was available in 96.5% of patients. The 2-year primary endpoint was significantly reduced after TAVR versus surgery (11.5% vs. 17.4%; hazard ratio: 0.63; 95% confidence interval: 0.45 to 0.88; p = 0.007). Differences in death and stroke favoring TAVR at 1 year were not statistically significant at 2 years (death: TAVR 2.4% vs. surgery 3.2%; p = 0.47; stroke: TAVR 2.4% vs. surgery 3.6%; p = 0.28). Valve thrombosis at 2 years was increased after TAVR (2.6%; 13 events) compared with surgery (0.7%; 3 events; p = 0.02). Disease-specific health status continued to be better after TAVR versus surgery through 2 years. Echocardiographic findings, including hemodynamic valve deterioration and bioprosthetic valve failure, were similar for TAVR and surgery at 2 years.

Conclusions: At 2 years, the primary endpoint remained significantly lower with TAVR versus surgery, but initial differences in death and stroke favoring TAVR were diminished and patients who underwent TAVR had increased valve thrombosis. (Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis [PARTNER 3]; NCT02675114).

Keywords: aortic stenosis; surgical aortic valve replacement; transcatheter aortic valve replacement.

Conflict of interest statement

Funding Support and Author Disclosures The PARTNER 3 Trial was funded by Edwards Lifesciences. Dr. Leon has received grant support, paid to his institution, from Edwards Lifesciences, Medtronic, Abbott, and Boston Scientific; and has received advisory board fees from Medtronic, Abbott, Boston Scientific, Gore, and Meril Life Sciences. Dr. Mack has received consulting fees from Gore; has served as a trial coprimary investigator for Edwards Lifesciences and Abbott; and has served as a study chair for Medtronic. Dr. Hahn has received consulting fees from Abbott Vascular, Siemens Healthineers, Boston Scientific, Bayliss, Edwards Lifesciences, Philips Healthcare, 3Mensio, Medtronic, and Navigate. Dr. Thourani has received grant support and has served as an advisor for Edwards Lifesciences. Dr. Makkar has received grant support from Abbott and Edwards Lifesciences. Dr. Kodali holds equity in BioTrace Medical, Dura Biotech, and Thubrikar Aortic Valve; has received grant support from Medtronic and Boston Scientific; has received grant support and consulting fees from Abbott Vascular; and has received consulting fees from Claret Medical, Admedus, and Meril Life Sciences. Ms. Alu has received research funding, paid to her institution, from Edwards Lifesciences and Abbott. Dr. Russo has received consulting fees, lecture fees, and fees for serving as a proctor from Edwards Lifesciences; has received consulting fees and fees for serving as a proctor from Abbott; and has received consulting fees from Boston Scientific. Dr. Malaisrie has received consulting fees from Medtronic; and has received lecture fees from Abbott. Dr. Cohen has received grant support, paid to his institution, from Edwards Lifesciences, Medtronic, Boston Scientific, and Abbott Vascular; and has received consulting fees from Edwards Lifesciences and Medtronic. Dr. Blanke has received consulting fees from Edwards Lifesciences, Tendyne (Abbott), Circle Cardiovascular Imaging, Neovasc, and Gore. Dr. Leipsic has received grant support from Abbott and Medtronic; and has received consulting fees and holds stock options from Circle Cardiovascular Imaging. Dr. McCabe has received consulting fees from Edwards Lifesciences. Dr. Babaliaros has received lecture fees and consulting fees from Edwards Lifesciences and Abbott. Dr. Goldman has received advisory board fees from Edwards Lifesciences. Dr. Szeto has received lecture fees and has served as an investigator for Edwards Lifesciences. Dr. Genereux has received consulting fees and advisory board fees from Abbott Vascular, Boston Scientific, Cardiovascular Solutions, and Cordis; has received consulting fees and fees for serving as a proctor from Edwards Lifesciences; and has received consulting fees from Medtronic, Saranas, Pi-Cardia, and Sig.Num. Dr. Webb has received consulting fees and fees for serving as a proctor from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.