# Renale denervatie veilig en effectief bij patiënten op antihypertensiva

*geplaatst 2023-11-07 · Hypertensie · Journal of the American College of Cardiology · doi 10.1016/j.jacc.2023.08.045 · https://hartvaat.nl/2023/11/07/renale-denervatie-veilig-en-effectief-bij-patienten-op-antihypertensiva/*

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.

## English: Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications.

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.

## Abstract (original, from the publication)

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).

Auteurs: 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

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Bron: Journal of the American College of Cardiology, https://doi.org/10.1016/j.jacc.2023.08.045. Bijgewerkt 2026-07-03T18:39:07Z. 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.