Atul Pathak1, MD; Ulrike M. Rudolph2, MD; Manish Saxena3, MBBS; Thomas Zeller4, MD; Jochen Müller-Ehmsen5, MD; Erik Lipsic6, MD; Roland E. Schmieder7, MD; Horst Sievert8, MD; Marcel Halbach9, MD; Faisal Sharif10, MBBS; Helen Parise11, ScD; Tim A. Fischell12, MD; Michael A. Weber13, MD; David E. Kandzari14, MD; Felix Mahfoud15,16, MD
1. Department of Cardiovascular Medicine, Princess Grace Hospital, Principality of Monaco; 2. Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Universität Leipzig, Leipzig, Germany; 3. Barts NIHR Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, London, UK; 4. Universitäts-Herzzentrum Bad Krozingen, Bad Krozingen, Germany; 5. Asklepios Klinik Altona, Hamburg, Germany; 6. Department of Cardiology, University Medical Center Groningen, Groningen, the Netherlands; 7. Universitätsklinikum Erlangen, Erlangen, Germany and Friedrich Alexander University Erlangen/Nürnberg, Erlangen, Germany; 8. CardioVasculäres Centrum (CVC) Frankfurt, Frankfurt, Germany; 9. University of Cologne, Faculty of Medicine and University Hospital Cologne, Clinic III for Internal Medicine, Cologne, Germany and Herzzentrum der Uniklinik Koln, Koln, Germany; 10. Saolta University Healthcare Group, University Hospital Galway, Galway, Ireland; 11. Yale University School of Medicine, New Haven, CT, USA; 12. Ablative Solutions Inc., Wakefield, MA, USA; 13. Division of Cardiovascular Medicine, State University of New York (SUNY), New York, NY, USA; 14. Department of Interventional Cardiology, Piedmont Heart Institute, Atlanta, GA, USA; 15. Department of Internal Medicine III - cardiology, angiology and internal intensive care medicine, Saarland University Medical Center, Homburg, Germany; 16. Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, MA, USA
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.
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miscellaneousresistant hypertensionuncontrolled hypertension
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