# TAVR met ballonexpandeerbare klep bij laagrisicopatiënten: NEJM PARTNER 3

*geplaatst 2019-05-02 · Atriumfibrilleren · The New England journal of medicine · doi 10.1056/NEJMoa1814052 · https://hartvaat.nl/2019/05/02/tavr-met-ballonexpandeerbare-klep-bij-laagrisicopatienten-nejm-partner-3/*

Landmark NEJM PARTNER 3-trial die TAVR met ballonexpandeerbare klep superieur toonde aan chirurgie bij laagrisicopatiënten. Samen met Evolut het definitieve bewijs.

## English: Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients.

The PARTNER 3 trial showed that TAVR with a balloon-expandable valve was superior to surgery for the composite of death, stroke, or rehospitalization at 1 year in patients with severe aortic stenosis at low surgical risk. This landmark result, alongside Evolut Low Risk, established TAVR as a viable alternative to surgery in virtually all aortic stenosis patients.

## Abstract (original, from the publication)

BACKGROUND: Among patients with aortic stenosis who are at intermediate or high risk for death with surgery, major outcomes are similar with transcatheter aortic-valve replacement (TAVR) and surgical aortic-valve replacement. There is insufficient evidence regarding the comparison of the two procedures in patients who are at low risk. METHODS: We randomly assigned patients with severe aortic stenosis and low surgical risk to undergo either TAVR with transfemoral placement of a balloon-expandable valve or surgery. The primary end point was a composite of death, stroke, or rehospitalization at 1 year. Both noninferiority testing (with a prespecified margin of 6 percentage points) and superiority testing were performed in the as-treated population. RESULTS: At 71 centers, 1000 patients underwent randomization. The mean age of the patients was 73 years, and the mean Society of Thoracic Surgeons risk score was 1.9% (with scores ranging from 0 to 100% and higher scores indicating a greater risk of death within 30 days after the procedure). The Kaplan-Meier estimate of the rate of the primary composite end point at 1 year was significantly lower in the TAVR group than in the surgery group (8.5% vs. 15.1%; absolute difference, -6.6 percentage points; 95% confidence interval [CI], -10.8 to -2.5; P<0.001 for noninferiority; hazard ratio, 0.54; 95% CI, 0.37 to 0.79; P = 0.001 for superiority). At 30 days, TAVR resulted in a lower rate of stroke than surgery (P = 0.02) and in lower rates of death or stroke (P = 0.01) and new-onset atrial fibrillation (P<0.001). TAVR also resulted in a shorter index hospitalization than surgery (P<0.001) and in a lower risk of a poor treatment outcome (death or a low Kansas City Cardiomyopathy Questionnaire score) at 30 days (P<0.001). There were no significant between-group differences in major vascular complications, new permanent pacemaker insertions, or moderate or severe paravalvular regurgitation. CONCLUSIONS: Among patients with severe aortic stenosis who were at low surgical risk, the rate of the composite of death, stroke, or rehospitalization at 1 year was significantly lower with TAVR than with surgery. (Funded by Edwards Lifesciences; PARTNER 3 ClinicalTrials.gov number, NCT02675114.).

Auteurs: Michael J Mack, Martin B Leon, Vinod H Thourani, Raj Makkar, Susheel K Kodali, Mark Russo, Samir R Kapadia, S Chris Malaisrie, David J Cohen, Philippe Pibarot, Jonathon Leipsic, Rebecca T Hahn, Philipp Blanke, Mathew R Williams, James M McCabe, David L Brown, Vasilis Babaliaros, Scott Goldman, Wilson Y Szeto, Philippe Genereux, Ashish Pershad, Stuart J Pocock, Maria C Alu, John G Webb, Craig R Smith

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Bron: The New England journal of medicine, https://doi.org/10.1056/NEJMoa1814052. Bijgewerkt 2026-07-03T13:27:07Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.