{"id":"00431fd35882","type":"article","url":"https://hartvaat.nl/2019/05/02/tavr-met-zelfexpanderende-klep-bij-laagrisicopatienten-nejm-evolut-low-risk/","title":"TAVR met zelfexpanderende klep bij laagrisicopatiënten: NEJM Evolut Low Risk","title_en":"Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog"],"tags":["ouderen","select-trial","summit-trial"],"journal":"The New England journal of medicine","doi":"10.1056/NEJMoa1816885","source_url":"https://doi.org/10.1056/NEJMoa1816885","authors":["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"],"significance":10,"published":"2019-05-02","source_date":"2019-05-02","image":"","kennis":[],"congress":"","summary_en":"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.","created":"2026-07-03T10:27:54Z","updated":"2026-07-03T13:27:07Z","licence":"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.","body_markdown":"Landmark NEJM Evolut Low Risk-trial die TAVR uitbreidde naar laagrisicopatiënten met ernstige aortaklepstenose. Paradigmashift in de klepbehandeling.","abstract_original":"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.)."}