Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial.

Autor:	Azizi M; Université de Paris, Paris, France; Hypertension Department and DMU CARTE, AP-HP Hôpital Européen Georges-Pompidou, Paris, France; INSERM, CIC1418, Paris, France. Electronic address: michel.azizi@aphp.fr., Sanghvi K; Deborah Heart and Lung Center, Browns Mills, NJ, USA., Saxena M; Barts NIHR Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, London, UK., Gosse P; Hôpital Saint-André CHU, Bordeaux, France., Reilly JP; Ochsner Heart and Vascular Institute, New Orleans, LA, USA., Levy T; Royal Bournemouth Hospital, Bournemouth, UK., Rump LC; University Clinic Dusseldorf, Dusseldorf, Germany., Persu A; Division of Cardiology, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium; Pole of Cardiovascular Research, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, Brussels, Belgium., Basile J; Seinsheimer Cardiovascular Health Program, Medical University of South Carolina, Ralph H Johnson VA Medical Center, Charleston, SC, USA., Bloch MJ; Department of Medicine, University of Nevada School of Medicine, Vascular Care, Renown Institute of Heart and Vascular Health, Reno, NV, USA., Daemen J; Erasmus MC, Department of Cardiology, University Medical Center Rotterdam, Rotterdam, Netherlands., Lobo MD; Barts NIHR Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, London, UK., Mahfoud F; Klinik für Innere Medizin III, Saarland University Hospital, Homburg/Saar, Germany; Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, MA, USA., Schmieder RE; Nephrology and Hypertension, University Hospital Erlangen, Friedrich Alexander University, Erlangen, Germany., Sharp ASP; Cardiology Department, University Hospital of Wales, Cardiff, UK; NIHR Clinical Research Facility, University of Exeter, Exeter, UK., Weber MA; Division of Cardiovascular Medicine, State University of New York, Downstate Medical Center, New York, NY, USA., Sapoval M; Université de Paris, Paris, France; Hypertension Department and DMU CARTE, AP-HP Hôpital Européen Georges-Pompidou, Paris, France., Fong P; Vanderbilt University Medical Center, Nashville, TN, USA., Pathak A; Department of Cardiovascular Medicine, Princess Grace Hospital, Monaco; UMR UT3 CNRS 5288, University of Toulouse, Toulouse, France., Lantelme P; Hôpital de la Croix Rousse, Lyon, France., Hsi D; Stamford Hospital, Stamford, CT, USA., Bangalore S; NYU School of Medicine, New York, NY, USA., Witkowski A; Institute of Cardiology, Warsaw, Poland., Weil J; Sana Kliniken Lübeck, Lübeck, Germany., Kably B; Université de Paris, Paris, France; AP-HP Hôpital Européen Georges-Pompidou, Pharmacology Unit and DMU CARTE, Paris, France., Barman NC; ReCor Medical, Palo Alto, CA, USA., Reeve-Stoffer H; ReCor Medical, Palo Alto, CA, USA., Coleman L; ReCor Medical, Palo Alto, CA, USA., McClure CK; NAMSA, Minneapolis, MN, USA., Kirtane AJ; Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY, USA.
Jazyk:	angličtina
Zdroj:	Lancet (London, England) [Lancet] 2021 Jun 26; Vol. 397 (10293), pp. 2476-2486. Date of Electronic Publication: 2021 May 16.
DOI:	10.1016/S0140-6736(21)00788-1
Abstrakt:	Background: Endovascular renal denervation reduces blood pressure in patients with mild-to-moderate hypertension, but its efficacy in patients with true resistant hypertension has not been shown. We aimed to assess the efficacy and safety of endovascular ultrasound renal denervation in patients with hypertension resistant to three or more antihypertensive medications. Methods: In a randomised, international, multicentre, single-blind, sham-controlled trial done at 28 tertiary centres in the USA and 25 in Europe, we included patients aged 18-75 years with office blood pressure of at least 140/90 mm Hg despite three or more antihypertensive medications including a diuretic. Eligible patients were switched to a once daily, fixed-dose, single-pill combination of a calcium channel blocker, an angiotensin receptor blocker, and a thiazide diuretic. After 4 weeks of standardised therapy, patients with daytime ambulatory blood pressure of at least 135/85 mm Hg were randomly assigned (1:1) by computer (stratified by centres) to ultrasound renal denervation or a sham procedure. Patients and outcome assessors were masked to randomisation. Addition of antihypertensive medications was allowed if specified blood pressure thresholds were exceeded. The primary endpoint was the change in daytime ambulatory systolic blood pressure at 2 months in the intention-to-treat population. Safety was also assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02649426. Findings: Between March 11, 2016, and March 13, 2020, 989 participants were enrolled and 136 were randomly assigned to renal denervation (n=69) or a sham procedure (n=67). Full adherence to the combination medications at 2 months among patients with urine samples was similar in both groups (42 [82%] of 51 in the renal denervation group vs 47 [82%] of 57 in the sham procedure group; p=0·99). Renal denervation reduced daytime ambulatory systolic blood pressure more than the sham procedure (-8·0 mm Hg [IQR -16·4 to 0·0] vs -3·0 mm Hg [-10·3 to 1·8]; median between-group difference -4·5 mm Hg [95% CI -8·5 to -0·3]; adjusted p=0·022); the median between-group difference was -5·8 mm Hg (95% CI -9·7 to -1·6; adjusted p=0·0051) among patients with complete ambulatory blood pressure data. There were no differences in safety outcomes between the two groups. Interpretation: Compared with a sham procedure, ultrasound renal denervation reduced blood pressure at 2 months in patients with hypertension resistant to a standardised triple combination pill. If the blood pressure lowering effect and safety of renal denervation are maintained in the long term, renal denervation might be an alternative to the addition of further antihypertensive medications in patients with resistant hypertension. Funding: ReCor Medical. Competing Interests: Declaration of interests MA has received research grants from the French Ministry of Health, Quantum Genomics, and the European Horizon 2020 programme; has received grant support and non-financial support from ReCor Medical and Idorsia; and has received personal fees from CVRx, AstraZeneca, Alnylam Pharmaceutical, and Poxel Pharma. KS has received grant support and personal fees from ReCor Medical and Medtronic, and has received grant support from Cardiovascular Systems. MSax has received grant support and personal fees from ReCor Medical. PG has received grant support from the University Hospital of Bordeaux. LCR has received personal fees from ReCor Medical. APe has received personal fees from Quantum Genomics and grant support from Ablative Solutions, Quantum Genomics, and ReCor Medical. JB has received grant support from ReCor Medical and Ablative Solutions. MJB has received personal fees from ReCor Medical and Medtronic. JD has received grant support from ReCor Medical, Medtronic, Boston Scientific, Abbott Vascular, Acist Medical, AstraZeneca, Pie Medical, and Pulse Cath, and personal fees from ReCor Medical, Medtronic, Acist Medical, Boston Scientific, Pie Medical, and Pulse Cath. MDL has received personal fees from ReCor Medical, Medtronic, CVRx, Ablative Solutions, Vascular Dynamics, ROX Medical, and Tarilan Laser Technologies, and grants from Medtronic. FM is supported by Deutsche Gesellschaft für Kardiologie and Deutsche Forschungsgemeinschaft (SFB TRR 219); and has received grant support and personal fees from ReCor Medical, Medtronic, Berlin Chemie, Bayer, and Boehringer Ingelheim. RES has received grant support and personal fees from ReCor Medical, Medtronic, and Ablative Solutions. ASPS has received personal fees from ReCor Medical, Medtronic, Boston Scientific, and Philips. MAW has received personal fees from ReCor Medical, Medtronic, Boston Scientific, and Ablative Solutions. APa has received grant support and personal fees from ReCor Medical, Medtronic, and Ablative Solutions. DH reports institutional funding to Stamford Hospital from ReCor Medical. SB has received grant support from Abbott Vascular, the National Heart, Lung, and Blood Institute, and REATA; and personal fees from Abbott Vascular, Biotronik, REATA, Amgen, Pfizer, Boehringer Ingelheim, and Meril. JW has received personal fees from ReCor Medical and Medtronic. NCB is an employee of ReCor Medical and is the author on multiple patents in the field of renal denervation. HR-S is an employee of ReCor Medical. LC is an employee of ReCor Medical. CKM is an employee of North American Science Associates and a contractor for ReCor Medical. AJK reports institutional funding (in addition to research grants, institutional funding includes fees paid for speaking engagements or consulting) to Columbia University or the Cardiovascular Research Foundation (New York, NY, USA) from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, Cardiovascular Systems, CathWorks, Siemens, Philips, and ReCor Medical. AJK also reports travel expenses or meals from Medtronic, Boston Scientific, Abbott Vascular, Abiomed, Cardiovascular Systems, CathWorks, Siemens, Philips, Chiesi, OpSens, Zoll, Regeneron, and ReCor Medical. All other authors declare no competing interests. (Copyright © 2021 Elsevier Ltd. All rights reserved.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu