{"id":"5606e1756b48","type":"article","url":"https://hartvaat.nl/2023/11/07/renale-denervatie-veilig-en-effectief-bij-patienten-op-antihypertensiva/","title":"Renale denervatie veilig en effectief bij patiënten op antihypertensiva","title_en":"Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications.","category":"hypertensie","category_label":"Hypertensie","professions":["cardioloog","internist"],"tags":["acuut-hartfalen","anemie-ckd","bloeddrukbehandeling","chronische-nierziekte","credence-trial","cystatine-c","diuretica","fidelio-dkd","fidelity","figaro-dkd","flow-trial","radiance-htn","renale-denervatie","sacubitril-valsartan"],"journal":"Journal of the American College of Cardiology","doi":"10.1016/j.jacc.2023.08.045","source_url":"https://doi.org/10.1016/j.jacc.2023.08.045","authors":["David E Kandzari","Raymond R Townsend","Kazuomi Kario","Felix Mahfoud","Michael A Weber","Roland E Schmieder","Stuart Pocock","Konstantinos Tsioufis","Dimitrios Konstantinidis","James Choi","Cara East","Lucas Lauder","Debbie L Cohen","Taisei Kobayashi","Axel Schmid","David P Lee","Adrian Ma","Joachim Weil","Tolga Agdirlioglu","Markus P Schlaich","Sharad Shetty","Chandan M Devireddy","Janice Lea","Jiro Aoki","Andrew S P Sharp","Richard Anderson","Martin Fahy","Vanessa DeBruin","Sandeep Brar","Michael Böhm"],"significance":7,"published":"2023-11-07","source_date":"2023-11-07","image":"","kennis":["https://hartvaat.nl/kennis/hypertensie/resistente-hypertensie/","https://hartvaat.nl/kennis/hypertensie/esc-richtlijn-hypertensie-2024/"],"congress":"","summary_en":"This pooled analysis confirmed that renal denervation significantly reduces blood pressure in patients already taking antihypertensive medications, supporting the device-based approach as an add-on therapy for inadequately controlled hypertension.","created":"2026-07-03T10:30:41Z","updated":"2026-07-03T18:39:07Z","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":"Gepoolde analyse bevestigde dat renale denervatie de bloeddruk significant verlaagt bij patiënten die al antihypertensiva gebruiken. Het additionele effect bovenop medicatie maakt RDN een realistische optie voor ongecontroleerde hypertensie.","abstract_original":"BACKGROUND: Renal denervation (RDN) reduces blood pressure (BP) in patients with uncontrolled hypertension in the absence of antihypertensive medications. OBJECTIVES: This trial assessed the safety and efficacy of RDN in the presence of antihypertensive medications. METHODS: SPYRAL HTN-ON MED is a prospective, randomized, sham-controlled, patient- and assessor-blinded trial enrolling patients from 56 clinical centers worldwide. Patients were prescribed 1 to 3 antihypertensive medications. Patients were randomized to radiofrequency RDN or sham control procedure. The primary efficacy endpoint was the baseline-adjusted change in mean 24-hour ambulatory systolic BP at 6 months between groups using a Bayesian trial design and analysis. RESULTS: The treatment difference in the mean 24-hour ambulatory systolic BP from baseline to 6 months between the RDN group (n = 206; -6.5 ± 10.7 mm Hg) and sham control group (n = 131; -4.5 ± 10.3 mm Hg) was -1.9 mm Hg (95% CI: -4.4 to 0.5 mm Hg; P = 0.12). There was no significant difference between groups in the primary efficacy analysis with a posterior probability of superiority of 0.51 (Bayesian treatment difference: -0.03 mm Hg [95% CI: -2.82 to 2.77 mm Hg]). However, there were changes and increases in medication intensity among sham control patients. RDN was associated with a reduction in office systolic BP compared with sham control at 6 months (adjusted treatment difference: -4.9 mm Hg; P = 0.0015). Night-time BP reductions and win ratio analysis also favored RDN. There was 1 adverse safety event among 253 assessed patients. CONCLUSIONS: There was no significant difference between groups in the primary analysis. However, multiple secondary endpoint analyses favored RDN over sham control. (SPYRAL HTN-ON MED Study [Global Clinical Study of Renal Denervation With the Symplicity Spyral Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications]; NCT02439775)."}