# TAVR met zelfexpanderende klep bij laagrisicopatiënten: NEJM Evolut Low Risk

*geplaatst 2019-05-02 · Atriumfibrilleren · The New England journal of medicine · doi 10.1056/NEJMoa1816885 · https://hartvaat.nl/2019/05/02/tavr-met-zelfexpanderende-klep-bij-laagrisicopatienten-nejm-evolut-low-risk/*

Landmark NEJM Evolut Low Risk-trial die TAVR uitbreidde naar laagrisicopatiënten met ernstige aortaklepstenose. Paradigmashift in de klepbehandeling.

## English: Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients.

The Evolut Low Risk trial demonstrated that self-expanding TAVR was noninferior to surgical aortic-valve replacement in low-surgical-risk patients with severe aortic stenosis for the composite of death or disabling stroke at 24 months. Together with PARTNER 3, this trial extended TAVR as a treatment option across the full spectrum of surgical risk.

## Abstract (original, from the publication)

BACKGROUND: Transcatheter aortic-valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis who are at increased risk for death from surgery; less is known about TAVR in low-risk patients. METHODS: We performed a randomized noninferiority trial in which TAVR with a self-expanding supraannular bioprosthesis was compared with surgical aortic-valve replacement in patients who had severe aortic stenosis and were at low surgical risk. When 850 patients had reached 12-month follow-up, we analyzed data regarding the primary end point, a composite of death or disabling stroke at 24 months, using Bayesian methods. RESULTS: Of the 1468 patients who underwent randomization, an attempted TAVR or surgical procedure was performed in 1403. The patients' mean age was 74 years. The 24-month estimated incidence of the primary end point was 5.3% in the TAVR group and 6.7% in the surgery group (difference, -1.4 percentage points; 95% Bayesian credible interval for difference, -4.9 to 2.1; posterior probability of noninferiority >0.999). At 30 days, patients who had undergone TAVR, as compared with surgery, had a lower incidence of disabling stroke (0.5% vs. 1.7%), bleeding complications (2.4% vs. 7.5%), acute kidney injury (0.9% vs. 2.8%), and atrial fibrillation (7.7% vs. 35.4%) and a higher incidence of moderate or severe aortic regurgitation (3.5% vs. 0.5%) and pacemaker implantation (17.4% vs. 6.1%). At 12 months, patients in the TAVR group had lower aortic-valve gradients than those in the surgery group (8.6 mm Hg vs. 11.2 mm Hg) and larger effective orifice areas (2.3 cm2 vs. 2.0 cm2). CONCLUSIONS: In patients with severe aortic stenosis who were at low surgical risk, TAVR with a self-expanding supraannular bioprosthesis was noninferior to surgery with respect to the composite end point of death or disabling stroke at 24 months. (Funded by Medtronic; ClinicalTrials.gov number, NCT02701283.).

Auteurs: Jeffrey J Popma, G Michael Deeb, Steven J Yakubov, Mubashir Mumtaz, Hemal Gada, Daniel O'Hair, Tanvir Bajwa, John C Heiser, William Merhi, Neal S Kleiman, Judah Askew, Paul Sorajja, Joshua Rovin, Stanley J Chetcuti, David H Adams, Paul S Teirstein, George L Zorn, John K Forrest, Didier Tchétché, Jon Resar, Antony Walton, Nicolo Piazza, Basel Ramlawi, Newell Robinson, George Petrossian, Thomas G Gleason, Jae K Oh, Michael J Boulware, Hongyan Qiao, Andrew S Mugglin, Michael J Reardon

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Bron: The New England journal of medicine, https://doi.org/10.1056/NEJMoa1816885. 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.