1. Long-Term, Patient-Level Analysis of Radiofrequency Renal Denervation in the SYMPLICITY Clinical Trial Program.
- Author
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Mahfoud F, Townsend RR, Kandzari DE, Mancia G, Whitbourn R, Lauder L, Bhatt DL, Kario K, Schmieder RE, Schlaich M, Fahy M, and Böhm M
- Abstract
Background: Renal denervation (RDN) lowers blood pressure (BP) in patients with uncontrolled hypertension. Current guidelines recommend RDN for patients with uncontrolled BP despite the use of antihypertensive (AH) medications. Durability of BP reductions and assessment of which patient baseline characteristics correlate with subsequent BP reductions are scarce., Objectives: The authors leveraged patient data from the entire SYMPLICITY Clinical program to model long-term BP reductions and assess patient characteristics associated with future BP reductions., Methods: Repeated BP measurements from each patient were analyzed using linear mixed models. Models were fitted with office systolic BP (SBP), 24-h ambulatory SBP, office diastolic BP (DBP), and 24-h ambulatory DBP as outcome variables. Baseline BP, baseline number of AH medications, AH medications over time, and other variables were included as fixed effects., Results: The mixed model included data from 4,155 patients treated with the Symplicity RDN system. The mean age was 60 ± 12 years, 40.4% of whom were female. Estimated, longitudinal office and 24-h ambulatory SBP changes through 36 months, after adjusting for AH medication effects, were biphasic, with a steep reduction after RDN through the first 6 months followed by continuous and steady reductions in office and 24-h SBP and DBP afterward through 36 months. Higher baseline office systolic or 24-h ambulatory SBP were correlated with greater reductions through follow-up in office and 24-h SBP, respectively. Patient characteristics consistent with high sympathetic nerve activity, such as atrial fibrillation and type 2 diabetes, emerged as statistically significant covariates associated with greater office systolic and office and 24-h diastolic BP reductions, respectively., Conclusions: Modeling suggested patients have durable BP reductions following RDN, with a steep immediate reduction followed by a steady reduction through 3 years., Competing Interests: Funding Source and Author Disclosures This study was funded by Medtronic. Dr Mahfoud is supported by Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Forschungsgemeinschaft (SFB TRR219, Project-ID 322900939), and Deutsche Herzstiftung. Saarland University has received scientific support from Ablative Solutions, Medtronic, and ReCor Medical. Until May 2024, Dr Mahfoud has received speaker honoraria/consulting fees from Ablative Solutions, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Inari, Medtronic, Merck, ReCor Medical, Servier, and Terumo. Dr Townsend is a consultant for Medtronic, Axio, Regeneron, Bard, OBIO, and AstraZeneca; and has received royalties from UpToDate. Dr Kandzari has received institutional research/grant support from Biotronik, Boston Scientific, Orbus Neich, Teleflex, Medtronic, and Ablative Solutions; he also has received personal consulting honoraria from Medtronic and HyperQure. Dr Mancia has received speaker honoraria from Berlin Chemie, Exicon Conshlting, Menarini Int, Merck Healthcare KGaA, Medtronic Inc USA, Recordati, Sanofi, Servier, and Sun Laboratories. Dr Lauder has received speaker honoraria/consulting fees from AstraZeneca, Medtronic, Pfizer, and ReCor Medical. Dr Bhatt is on the advisory board for Angiowave, Bayer, Boehringer Ingelheim, Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardiology, High Enroll, Janssen, Level Ex, McKinsey, Medscape Cardiology, Merck, MyoKardia, NirvaMed, Novo Nordisk, PhaseBio, PLx Pharma, and Stasys; is on the board of directors for American Heart Association New York City, Angiowave (stock options), Bristol Myers Squibb (stock), DRS.LINQ (stock options), and High Enroll (stock); is a consultant for Broadview Ventures, Hims; is on the data monitoring committees for Acesion Pharma, Assistance Publique-Hôpitaux de Paris, Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial, funded by St. Jude Medical, now Abbott), Boston Scientific (Chair, PEITHO trial), Cleveland Clinic, Contego Medical (Chair, PERFORMANCE 2), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial, funded by Daiichi Sankyo; for the ABILITY-DM trial, funded by Concept Medical), Novartis, Population Health Research Institute; Rutgers University (for the NIH-funded MINT Trial); has received honoraria from American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Chair, ACC Accreditation Oversight Committee), Arnold and Porter law firm (work related to Sanofi/Bristol-Myers Squibb clopidogrel litigation), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Canadian Medical and Surgical Knowledge Translation Research Group (clinical trial steering committees), CSL Behring (AHA lecture), Cowen and Company, Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), K2P (Co-Chair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (CME steering committees), MJH Life Sciences, Oakstone CME (Course Director, Comprehensive Review of Interventional Cardiology), Piper Sandler, Population Health Research Institute (for the COMPASS operations committee, publications committee, steering committee, and USA national co-leader, funded by Bayer), WebMD (CME steering committees), Wiley (steering committee); other services from Clinical Cardiology (Deputy Editor); holds a patent on Sotagliflozin (named on a patent for sotagliflozin assigned to Brigham and Women's Hospital who assigned to Lexicon; neither I nor Brigham and Women's Hospital receive any income from this patent); has received research funding from Abbott, Acesion Pharma, Afimmune, Aker Biomarine, Alnylam, Amarin, Amgen, AstraZeneca, Bayer, Beren, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, CinCor, Cleerly, CSL Behring, Eisai, Ethicon, Faraday Pharmaceuticals, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Garmin, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Javelin, Lexicon, Lilly, Medtronic, Merck, Moderna, MyoKardia, NirvaMed, Novartis, Novo Nordisk, Otsuka, Owkin, Pfizer, PhaseBio, PLx Pharma, Recardio, Regeneron, Reid Hoffman Foundation, Roche, Sanofi, Stasys, Synaptic, The Medicines Company, Youngene, 89Bio; has received royalties from Elsevier (Editor, Braunwald's Heart Disease); is a site co-investigator for Abbott, Biotronik, Boston Scientific, CSI, Endotronix, St. Jude Medical (now Abbott), Philips, SpectraWAVE, Svelte, Vascular Solutions; is a trustee of the American College of Cardiology; and has done unfunded research for FlowCo. Dr Kario has received personal fees from Medtronic; has received grants from A&D Company, JIMRO, Omron Healthcare, CureApp, Terumo, and Fukuda Denshi; has received honoraria from Otsuka Pharmaceuticals and Omron Healthcare, and has participated on the advisory board of Fukuda Denshi outside the submitted work. Dr Schmieder has received speaker and consulting honoraria from Medtronic, Recor, and Ablative solutions. Research grants have been given to his institution from Medtronic, Recor, and Ablative solutions. Dr Fahy was an employee of Medtronic. Dr Böhm is supported by the Deutsche Forschungsgemeinshaft (SFB TTR219); and has received personal fees from Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Medtronic, Novartis, ReCor Medical, Servier, and Vifor. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.)
- Published
- 2025
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