Alcohol-mediated renal denervation in patients with hypertension in the absence of antihypertensive medications

Pathak A, Rudolph UM, Saxena M, Zeller T, Müller-Ehmsen J, Lipsic E, Schmieder R, Sievert H, Halbach M, Sharif F, Parise H, Fischell TA, Weber MA, Kandzari DE, Mahfoud F (2023)

Publication Type: Journal article

Publication year: 2023

Journal

EuroIntervention Europa Group

Book Volume: 19

Pages Range: 602-611

Journal Issue: 7

DOI: 10.4244/EIJ-D-23-00088

Abstract

BACKGROUND: Ultrasound and radiofrequency renal denervation (RDN) have been shown to safely lower blood pressure (BP) in hypertension. AIMS: The TARGET BP OFF-MED trial investigated the efficacy and safety of alcohol-mediated renal denervation (RDN) in the absence of antihypertensive medications. METHODS: This randomised, blinded, sham-controlled trial was conducted in 25 centres in Europe and the USA. Patients with a 24-hour systolic BP of 135-170 mmHg, an office systolic BP 140-180 mmHg and diastolic BP ≥90 mmHg on 0-2 antihypertensive medications were enrolled. The primary efficacy endpoint was the change in mean 24-hour systolic BP at 8 weeks. Safety endpoints included major adverse events up to 30 days. RESULTS: A total of 106 patients were randomised; the baseline mean office BP following medication washout was 159.4/100.4±10.9/7.0 mmHg (RDN) and 160.1/98.3±11.0/6.1 mmHg (sham), respectively. At 8 weeks post-procedure, the mean (±standard deviation) 24-hour systolic BP change was â2.9±7.4 mmHg (p=0.009) versus â1.4±8.6 mmHg (p=0.25) in the RDN and sham groups, respectively (mean between-group difference: 1.5 mmHg; p=0.27). There were no differences in safety events between groups. After 12 months of blinded follow-up, with medication escalation, patients achieved similar office systolic BP (RDN: 147.9±18.5 mmHg; sham: 147.8±15.1 mmHg; p=0.68) with a significantly lower medication burden in the RDN group (mean daily defined dose: 1.5±1.5 vs 2.3±1.7; p=0.017). CONCLUSIONS: In this trial, alcohol-mediated RDN was delivered safely but was not associated with significant BP differences between groups. Medication burden was lower in the RDN group up to 12 months.

Authors with CRIS profile

Roland Schmieder Professur für Innere Medizin (Nephrologie)

Involved external institutions

Centre Hospitalier Princesse Grace MC Monaco (MC) Universitätsklinikum Leipzig DE Germany (DE) Queen Mary, University of London GB United Kingdom (GB) Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH DE Germany (DE) Asklepios Klinik Altona DE Germany (DE) University Medical Center Groningen (UMCG) / Universitair Medisch Centrum Groningen NL Netherlands (NL) CardioVasculäres Centrum Frankfurt DE Germany (DE) Universität zu Köln DE Germany (DE) University Hospital Galway IE Ireland (IE) Yale School of Medicine US United States (USA) (US) Ablative Solutions US United States (USA) (US) State University of New York at Albany (UNY Albany / UAlbany) US United States (USA) (US) Piedmont Healthcare US United States (USA) (US) Universitätsklinikum des Saarlandes (UKS) DE Germany (DE)

How to cite

APA:

Pathak, A., Rudolph, U.M., Saxena, M., Zeller, T., Müller-Ehmsen, J., Lipsic, E.,... Mahfoud, F. (2023). Alcohol-mediated renal denervation in patients with hypertension in the absence of antihypertensive medications. EuroIntervention, 19(7), 602-611. https://dx.doi.org/10.4244/EIJ-D-23-00088

MLA:

Pathak, Atul, et al. "Alcohol-mediated renal denervation in patients with hypertension in the absence of antihypertensive medications." EuroIntervention 19.7 (2023): 602-611.

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