Endovascular Ultrasound Renal Denervation to Treat Hypertension: The RADIANCE II Randomized Clinical Trial.

Autor:	Azizi M; Université Paris Cité, Paris, France.; AP-HP, Hôpital Européen Georges-Pompidou, Hypertension Department and DMU CARTE, Paris, France.; INSERM, CIC1418, Paris, France., Saxena M; Barts NIHR Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, London, England., Wang Y; Minneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, Minnesota., Jenkins JS; Ochsner Medical Center, New Orleans, Louisiana., Devireddy C; Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia., Rader F; Cedars-Sinai Heart Institute, Los Angeles, California., Fisher NDL; Brigham and Women's Hospital, Boston, Massachusetts., Schmieder RE; Nephrology and Hypertension, University Hospital Erlangen, Friedrich Alexander University, Erlangen, Germany., Mahfoud F; Klinik für Innere Medizin III, Saarland University Hospital, Homburg, Germany.; Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge., Lindsey J; Saint Luke's Mid America Heart Institute, Kansas City, Missouri., Sanghvi K; Deborah Heart and Lung Center, Brown Mills, New Jersey., Todoran TM; Division of Cardiovascular Medicine, Medical University of South Carolina, Charleston.; Ralph H. Johnson VA Medical Center, Charleston, South Carolina., Pacella J; University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania., Flack J; Springfield Memorial Hospital, Southern Illinois University School of Medicine, Springfield., Daemen J; Erasmus MC, Department of Cardiology, University Medical Center Rotterdam, Rotterdam, the Netherlands., Sharp ASP; University Hospital of Wales, Cardiff, England.; University of Exeter, Exeter, England., Lurz P; Heart Center Leipzig, University of Leipzig, Leipzig, Germany., Bloch MJ; Vascular Care, Renown Institute of Heart and Vascular Health, Department of Medicine, University of Nevada School of Medicine, Reno., Weber MA; Downstate Medical Center, Division of Cardiovascular Medicine, State University of New York, New York., Lobo MD; Barts NIHR Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, London, England., Basile J; Division of Cardiovascular Medicine, Medical University of South Carolina, Charleston., Claude L; ReCor Medical, Inc, Palo Alto, California., Reeve-Stoffer H; ReCor Medical, Inc, Palo Alto, California., McClure CK; NAMSA, Minneapolis, Minnesota., Kirtane AJ; Columbia University Medical Center/NewYork-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York.
Jazyk:	angličtina
Zdroj:	JAMA [JAMA] 2023 Feb 28; Vol. 329 (8), pp. 651-661.
DOI:	10.1001/jama.2023.0713
Abstrakt:	Importance: Two initial sham-controlled trials demonstrated that ultrasound renal denervation decreases blood pressure (BP) in patients with mild to moderate hypertension and hypertension that is resistant to treatment. Objective: To study the efficacy and safety of ultrasound renal denervation without the confounding influence of antihypertensive medications in patients with hypertension. Design, Setting, and Participants: Sham-controlled, randomized clinical trial with patients and outcome assessors blinded to treatment assignment that was conducted between January 14, 2019, and March 25, 2022, at 37 centers in the US and 24 centers in Europe, with randomization stratified by center. Patients aged 18 years to 75 years with hypertension (seated office systolic BP [SBP] ≥140 mm Hg and diastolic BP [DBP] ≥90 mm Hg despite taking up to 2 antihypertensive medications) were eligible if they had an ambulatory SBP/DBP of 135/85 mm Hg or greater and an SBP/DBP less than 170/105 mm Hg after a 4-week washout of their medications. Patients with an estimated glomerular filtration rate of 40 mL/min/1.73 m2 or greater and with suitable renal artery anatomy were randomized 2:1 to undergo ultrasound renal denervation or a sham procedure. Patients were to abstain from antihypertensive medications until the 2-month follow-up unless prespecified BP criteria were exceeded and were associated with clinical symptoms. Interventions: Ultrasound renal denervation vs a sham procedure. Main Outcomes and Measures: The primary efficacy outcome was the mean change in daytime ambulatory SBP at 2 months. The primary safety composite outcome of major adverse events included death, kidney failure, and major embolic, vascular, cardiovascular, cerebrovascular, and hypertensive events at 30 days and renal artery stenosis greater than 70% detected at 6 months. The secondary outcomes included mean change in 24-hour ambulatory SBP, home SBP, office SBP, and all DBP parameters at 2 months. Results: Among 1038 eligible patients, 150 were randomized to ultrasound renal denervation and 74 to a sham procedure (mean age, 55 years [SD, 9.3 years]; 28.6% female; and 16.1% self-identified as Black or African American). The reduction in daytime ambulatory SBP was greater with ultrasound renal denervation (mean, -7.9 mm Hg [SD, 11.6 mm Hg]) vs the sham procedure (mean, -1.8 mm Hg [SD, 9.5 mm Hg]) (baseline-adjusted between-group difference, -6.3 mm Hg [95% CI, -9.3 to -3.2 mm Hg], P < .001), with a consistent effect of ultrasound renal denervation throughout the 24-hour circadian cycle. Among 7 secondary BP outcomes, 6 were significantly improved with ultrasound renal denervation vs the sham procedure. No major adverse events were reported in either group. Conclusions and Relevance: In patients with hypertension, ultrasound renal denervation reduced daytime ambulatory SBP at 2 months in the absence of antihypertensive medications vs a sham procedure without postprocedural major adverse events. Trial Registration: ClinicalTrials.gov Identifier: NCT03614260.
Databáze:	MEDLINE
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