|
|||||
|
|
12-Month Results From the Unblinded Phase of the RADIANCE-HTN SOLO Trial of Ultrasound Renal Denervation |
|
| Institution: | 1. Université de Paris, Paris, France;2. AP-HP, Hôpital Européen Georges-Pompidou, Hypertension Department and DMU CARTE, Paris, France;3. INSERM, CIC1418, Paris, France;4. Erasmus Medical Center, University Medical Center Rotterdam, Department of Cardiology, Rotterdam, the Netherlands;5. Barts NIHR Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, London, United Kingdom;6. Klinik für Innere Medizin III, Saarland University Hospital, Homburg/Saar, Germany;7. Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA;8. University Hospital of Wales, Cardiff and University of Exeter, Exeter, United Kingdom;9. Nephrology and Hypertension, University Hospital Erlangen, Friedrich Alexander University, Erlangen, Germany;10. Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota, USA;11. Heart Center Leipzig, University of Leipzig, Leipzig, Germany;12. The Essex Cardiothoracic Centre, Essex, United Kingdom;13. Department of Medicine, University of Nevada School of Medicine, Vascular Care, Renown Institute of Heart and Vascular Health, Reno, Nevada, USA;14. Seinsheimer Cardiovascular Health Program, Medical University of South Carolina, Ralph H. Johnson VA Medical Center, Charleston, South Carolina, USA;15. Division of Cardiovascular Medicine, State University of New York, Downstate Medical Center, New York, New York, USA;p. University Clinic Dusseldorf, Dusseldorf, Germany;q. Royal Bournemouth Hospital, Dorset, United Kingdom;r. Deborah Heart & Lung Center, Brown Mills, New Jersey, USA;s. Cedars-Sinai Heart Institute, Los Angeles, California, USA;t. Brigham and Women’s Hospital, Boston, Massachusetts, USA;u. Hôpital Saint-André–CHU, Bordeaux, France;v. University of Utah Medical Center, Salt Lake City, Utah, USA;w. ReCor Medical, Palo Alto, California, USA;x. NAMSA, Minneapolis, Minnesota, USA;y. The Baim Institute for Clinical Research, Boston, Massachusetts, USA;z. Columbia University Medical Center/NewYork-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York, USA |
| Abstract: | ObjectivesThis 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.BackgroundThe 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.MethodsPatients 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.ResultsSixty-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 (1.0 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.ConclusionsDespite unblinding, the BP-lowering effect of RDN was maintained at 12 months with fewer prescribed medications compared with sham. |
| Keywords: | blood pressure hypertension renal denervation ultrasound variability BP"} {"#name":"keyword" "$":{"id":"kwrd0040"} "$$":[{"#name":"text" "_":"blood pressure CI"} {"#name":"keyword" "$":{"id":"kwrd0050"} "$$":[{"#name":"text" "_":"confidence interval CT"} {"#name":"keyword" "$":{"id":"kwrd0060"} "$$":[{"#name":"text" "_":"computed tomographic DDD"} {"#name":"keyword" "$":{"id":"kwrd0070"} "$$":[{"#name":"text" "_":"defined daily dose eGFR"} {"#name":"keyword" "$":{"id":"kwrd0080"} "$$":[{"#name":"text" "_":"estimated glomerular filtration rate HR"} {"#name":"keyword" "$":{"id":"kwrd0090"} "$$":[{"#name":"text" "_":"heart rate MR"} {"#name":"keyword" "$":{"id":"kwrd0100"} "$$":[{"#name":"text" "_":"magnetic resonance RDN"} {"#name":"keyword" "$":{"id":"kwrd0110"} "$$":[{"#name":"text" "_":"renal denervation SBP"} {"#name":"keyword" "$":{"id":"kwrd0120"} "$$":[{"#name":"text" "_":"systolic blood pressure VVV"} {"#name":"keyword" "$":{"id":"kwrd0130"} "$$":[{"#name":"text" "_":"visit-to-visit variability |
| 本文献已被 ScienceDirect 等数据库收录！ | |