Felix Mahfoud1,2, MD; Michael J. Bloch3, MD; Michel Azizi4, MD; Yale Wang5, MD; Roland E. Schmieder6, MD; Melvin D. Lobo7, MD; Andrew S.P. Sharp8, MD; Joost Daemen9, MD; Jan Basile10, MD; Michael A. Weber11, MD; Andrea P. Scicli12, PhD; Candace K. McClure13, PhD; Ajay J. Kirtane14, MD
1. Klinik für Innere Medizin III, Saarland University Hospital, Homburg/Saar, Germany; 2. Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, MA, USA; 3. Department of Medicine, University of Nevada School of Medicine, Vascular Care, Renown Institute of Heart and Vascular Health, Reno, NV, USA; 4. Université de Paris, Paris, and AP-HP, Hôpital Européen Georges-Pompidou, Hypertension Department, and DMU CARTE, Paris, France; 5. Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, MN, USA; 6. Nephrology and Hypertension, University Hospital Erlangen, Friedrich Alexander University, Erlangen, Germany; 7. Barts NIHR Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, London, United Kingdom; 8. University Hospital of Wales, Cardiff, and University of Exeter, Exeter, United Kingdom; 9. Erasmus University Medical Center, Department of Cardiology, Rotterdam, the Netherlands; 10. Seinsheimer Cardiovascular Health Program, Medical University of South Carolina, Ralph H. Johnson VA Medical Center, Charleston, SC, USA; 11. Division of Cardiovascular Medicine, State University of New York, Downstate Medical Center, New York, NY, USA; 12. ReCor Medical, Inc., Palo Alto, CA, USA; 13. NAMSA, Minneapolis, MN, USA; 14. Columbia University Medical Center/NewYork-Presbyterian Hospital, and the Cardiovascular Research Foundation, New York, NY, USA
Background: The multicentre, randomised, sham-controlled RADIANCE-HTN SOLO trial reported the blood pressure (BP)-lowering efficacy and safety of ultrasound renal denervation (RDN) in the absence (2 months) and presence (6 and 12 months) of antihypertensive medications in patients with mild-to-moderate hypertension.
Aims: The aim of this report was to evaluate patients originally assigned to the sham group who crossed over to RDN.
Methods: After the primary endpoint was met, patients in the sham arm who remained uncontrolled were allowed to cross over to receive RDN. All patients were unblinded and treated with standard of care medications at the time of crossover. Ambulatory BP was evaluated 2 and 6 months after crossover.
Results: Among 72 subjects of the sham arm, 33 underwent ultrasound RDN after an average follow-up of 23±6 months. Prior to crossover, patients had a daytime ambulatory BP of 144.1±10.1/89.9±8.4 mmHg and received 1.2±0.8 antihypertensive medications. Mean change in daytime ambulatory BP from pre-crossover to 2 and 6 months post RDN was –11.2±13.7/–7.1±8.9 mmHg (n=33; p<0.001; p<0.001) and –10.8±17.3/–7.8±11.6 mmHg (n=27; p=0.002; p<0.001). The number of antihypertensive medications did not change from pre-crossover baseline to 2 and 6 months. Eighteen of 33 (54.5%) patients had their daytime ambulatory BP controlled (<135/85 mmHg) at 2 months and 44.4% (12/27) at 6 months post RDN. No major procedure-related adverse events occurred.
Conclusions: During unblinded long-term follow-up of the RADIANCE-HTN SOLO study, patients originally assigned to a sham procedure who remained uncontrolled had significant reductions in BP following crossover treatment with ultrasound RDN.
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