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
Book Volume: 19
Pages Range: 602-611
Journal Issue: 7
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.
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://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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