Michel Azizi1, Joost Daemen2, Melvin D Lobo3, Felix Mahfoud4, Andrew S P Sharp5, Roland E Schmieder6, Yale Wang7, Manish Saxena3, Philipp Lurz8, Jeremy Sayer9, Michael J Bloch10, Jan Basile11, Michael A Weber12, Lars C Rump13, Terry Levy14, Marc Sapoval15, Kintur Sanghvi16, Florian Rader17, Naomi D L Fisher18, Philippe Gosse19, Josephine Abraham20, Lisa Claude21, Neil C Barman21, Candace K McClure22, Yuyin Liu23, Ajay J Kirtane24. 1. Université de Paris, Paris, France; AP-HP, Hôpital Européen Georges-Pompidou, Hypertension Department and DMU CARTE, Paris, France; INSERM, CIC1418, Paris, France. Electronic address: michel.azizi@aphp.fr. 2. Erasmus Medical Center, University Medical Center Rotterdam, Department of Cardiology, Rotterdam, the Netherlands. 3. Barts NIHR Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, London, United Kingdom. 4. Klinik für Innere Medizin III, Saarland University Hospital, Homburg/Saar, Germany; Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA. 5. University Hospital of Wales, Cardiff and University of Exeter, Exeter, United Kingdom. 6. Nephrology and Hypertension, University Hospital Erlangen, Friedrich Alexander University, Erlangen, Germany. 7. Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA. 8. Heart Center Leipzig, University of Leipzig, Leipzig, Germany. 9. The Essex Cardiothoracic Centre, Essex, United Kingdom. 10. Department of Medicine, University of Nevada School of Medicine, Vascular Care, Renown Institute of Heart and Vascular Health, Reno, Nevada, USA. 11. Seinsheimer Cardiovascular Health Program, Medical University of South Carolina, Ralph H. Johnson VA Medical Center, Charleston, South Carolina, USA. 12. Division of Cardiovascular Medicine, State University of New York, Downstate Medical Center, New York, New York, USA. 13. University Clinic Dusseldorf, Dusseldorf, Germany. 14. Royal Bournemouth Hospital, Dorset, United Kingdom. 15. Université de Paris, Paris, France; AP-HP, Hôpital Européen Georges-Pompidou, Hypertension Department and DMU CARTE, Paris, France; INSERM, CIC1418, Paris, France. 16. Deborah Heart & Lung Center, Brown Mills, New Jersey, USA. 17. Cedars-Sinai Heart Institute, Los Angeles, California, USA. 18. Brigham and Women's Hospital, Boston, Massachusetts, USA. 19. Hôpital Saint-André-CHU, Bordeaux, France. 20. University of Utah Medical Center, Salt Lake City, Utah, USA. 21. ReCor Medical, Palo Alto, California, USA. 22. NAMSA, Minneapolis, Minnesota, USA. 23. The Baim Institute for Clinical Research, Boston, Massachusetts, USA. 24. Columbia University Medical Center/NewYork-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York, USA.
Abstract
OBJECTIVES: This study reports the 12-month results of the RADIANCE-HTN (A Study of the ReCor Medical Paradise System in Clinical Hypertension) SOLO trial following unblinding of patients at 6 months. BACKGROUND: The blood pressure (BP)-lowering efficacy and safety of endovascular ultrasound renal denervation (RDN) in the absence (2 months) and presence (6 months) of antihypertensive medications were previously reported. METHODS:Patients with daytime ambulatory BP ≥135/85 mm Hg after 4 weeks off medication were randomized to RDN (n = 74) or sham (n = 72) and maintained off medication for 2 months. A standardized medication escalation protocol was instituted between 2 and 5 months (blinded phase). Between 6 and 12 months (unblinded phase), patients received antihypertensive medications at physicians' discretion. Outcomes at 12 months included medication burden, change in daytime ambulatory systolic BP (dASBP) and office or home systolic BP (SBP), visit-to-visit variability in SBP, and safety. RESULTS:Sixty-five of 74 RDN patients and 67 of 72 sham patients had 12-month dASBP measurements. The proportion of patients on ≥2 medications (27.7% vs. 44.8%; p = 0.041), the number of medications (0 vs. 1.4; p = 0.015), and defined daily dose (1.4 vs. 2.2; p = 0.007) were less with RDN versus sham. The decrease in dASBP from baseline in the RDN group (-16.5 ± 12.9 mm Hg) remained stable at 12 months. The RDN versus sham adjusted difference at 12 months was -2.3 mm Hg (95% confidence interval [CI]: -5.9 to 1.3 mm Hg; p = 0.201) for dASBP, -6.3 mm Hg (95% CI: -11.1 to -1.5 mm Hg; p = 0.010) for office SBP, and -3.4 mm Hg (95% CI: -6.9 to 0.1 mm Hg; p = 0.062) for home SBP. Visit-to-visit variability in SBP was smaller in the RDN group. No renal artery injury was detected on computed tomographic or magnetic resonance angiography. CONCLUSIONS: Despite unblinding, the BP-lowering effect of RDN was maintained at 12 months with fewer prescribed medications compared with sham.
RCT Entities:
OBJECTIVES: This study reports the 12-month results of the RADIANCE-HTN (A Study of the ReCor Medical Paradise System in Clinical Hypertension) SOLO trial following unblinding of patients at 6 months. BACKGROUND: The blood pressure (BP)-lowering efficacy and safety of endovascular ultrasound renal denervation (RDN) in the absence (2 months) and presence (6 months) of antihypertensive medications were previously reported. METHODS:Patients with daytime ambulatory BP ≥135/85 mm Hg after 4 weeks off medication were randomized to RDN (n = 74) or sham (n = 72) and maintained off medication for 2 months. A standardized medication escalation protocol was instituted between 2 and 5 months (blinded phase). Between 6 and 12 months (unblinded phase), patients received antihypertensive medications at physicians' discretion. Outcomes at 12 months included medication burden, change in daytime ambulatory systolic BP (dASBP) and office or home systolic BP (SBP), visit-to-visit variability in SBP, and safety. RESULTS: Sixty-five of 74 RDN patients and 67 of 72 sham patients had 12-month dASBP measurements. The proportion of patients on ≥2 medications (27.7% vs. 44.8%; p = 0.041), the number of medications (0 vs. 1.4; p = 0.015), and defined daily dose (1.4 vs. 2.2; p = 0.007) were less with RDN versus sham. The decrease in dASBP from baseline in the RDN group (-16.5 ± 12.9 mm Hg) remained stable at 12 months. The RDN versus sham adjusted difference at 12 months was -2.3 mm Hg (95% confidence interval [CI]: -5.9 to 1.3 mm Hg; p = 0.201) for dASBP, -6.3 mm Hg (95% CI: -11.1 to -1.5 mm Hg; p = 0.010) for office SBP, and -3.4 mm Hg (95% CI: -6.9 to 0.1 mm Hg; p = 0.062) for home SBP. Visit-to-visit variability in SBP was smaller in the RDN group. No renal artery injury was detected on computed tomographic or magnetic resonance angiography. CONCLUSIONS: Despite unblinding, the BP-lowering effect of RDN was maintained at 12 months with fewer prescribed medications compared with sham.
Authors: V J M Zeijen; A A Kroon; B H van den Born; P J Blankestijn; S C A Meijvis; A Nap; E Lipsic; A Elvan; J Versmissen; R J van Geuns; M Voskuil; P A L Tonino; W Spiering; J Deinum; J Daemen Journal: Neth Heart J Date: 2022-08-24 Impact factor: 2.854
Authors: Yook Chin Chia; Wan Azman Wan Ahmad; Alan Yean Yip Fong; Azhari Rosman; Abdul Rashid Abdul Rahman; Gim Hooi Choo; Soo Kun Lim; Mohammad Zawawi Abu Bakar; Tiong Kiam Ong Journal: Hypertens Res Date: 2022-06-01 Impact factor: 5.528