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Randomized Controlled Trial
. 2023 Nov 7;82(19):1809-1823.
doi: 10.1016/j.jacc.2023.08.045.

Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications

David E Kandzari  1 , Raymond R Townsend  2 , Kazuomi Kario  3 , Felix Mahfoud  4 , Michael A Weber  5 , Roland E Schmieder  6 , Stuart Pocock  7 , Konstantinos Tsioufis  8 , Dimitrios Konstantinidis  8 , James Choi  9 , Cara East  9 , Lucas Lauder  4 , Debbie L Cohen  2 , Taisei Kobayashi  2 , Axel Schmid  6 , David P Lee  10 , Adrian Ma  10 , Joachim Weil  11 , Tolga Agdirlioglu  11 , Markus P Schlaich  12 , Sharad Shetty  12 , Chandan M Devireddy  13 , Janice Lea  13 , Jiro Aoki  14 , Andrew S P Sharp  15 , Richard Anderson  15 , Martin Fahy  16 , Vanessa DeBruin  16 , Sandeep Brar  16 , Michael Böhm  4 ; SPYRAL HTN-ON MED Investigators
Collaborators, Affiliations
Free article
Randomized Controlled Trial

Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications

David E Kandzari et al. J Am Coll Cardiol. .
Free article

Abstract

Background: Renal denervation (RDN) reduces blood pressure (BP) in patients with uncontrolled hypertension in the absence of antihypertensive medications.

Objectives: This trial assessed the safety and efficacy of RDN in the presence of antihypertensive medications.

Methods: SPYRAL HTN-ON MED is a prospective, randomized, sham-controlled, patient- and assessor-blinded trial enrolling patients from 56 clinical centers worldwide. Patients were prescribed 1 to 3 antihypertensive medications. Patients were randomized to radiofrequency RDN or sham control procedure. The primary efficacy endpoint was the baseline-adjusted change in mean 24-hour ambulatory systolic BP at 6 months between groups using a Bayesian trial design and analysis.

Results: The treatment difference in the mean 24-hour ambulatory systolic BP from baseline to 6 months between the RDN group (n = 206; -6.5 ± 10.7 mm Hg) and sham control group (n = 131; -4.5 ± 10.3 mm Hg) was -1.9 mm Hg (95% CI: -4.4 to 0.5 mm Hg; P = 0.12). There was no significant difference between groups in the primary efficacy analysis with a posterior probability of superiority of 0.51 (Bayesian treatment difference: -0.03 mm Hg [95% CI: -2.82 to 2.77 mm Hg]). However, there were changes and increases in medication intensity among sham control patients. RDN was associated with a reduction in office systolic BP compared with sham control at 6 months (adjusted treatment difference: -4.9 mm Hg; P = 0.0015). Night-time BP reductions and win ratio analysis also favored RDN. There was 1 adverse safety event among 253 assessed patients.

Conclusions: There was no significant difference between groups in the primary analysis. However, multiple secondary endpoint analyses favored RDN over sham control. (SPYRAL HTN-ON MED Study [Global Clinical Study of Renal Denervation With the Symplicity Spyral Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications]; NCT02439775).

Keywords: Bayesian trial; antihypertensive medications; renal denervation; uncontrolled hypertension; win ratio.

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Conflict of interest statement

Funding Support and Author Disclosures This study was funded by Medtronic. Dr Kandzari has received institutional research/grant support from Biotronik, Boston Scientific, Cardiovascular Systems, Inc, Orbus Neich, Teleflex, Medtronic, and Ablative Solutions; and has received personal consulting honoraria from Cardiovascular Systems, Inc, Medtronic, and Abbott Vascular. Dr Townsend is a consultant for Medtronic, Cytel, and Janssen. Dr Kario has received personal fees from Medtronic during the conduct of the study; has received grants from A&D Company, Omron Healthcare, Fukuda Denshi, CureApp, Sanwa Kagaku Kenkyusho, Teijin Pharma, Boehringer Ingelheim Japan, and Fukuda Lifetec; has received consulting fees 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 of the submitted work. Dr Mahfoud is supported by Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Forschungsgemeinschaft (SFB TRR219), and Deutsche Herzstiftung; has received scientific support from Ablative Solutions, Medtronic, and ReCor Medical; and has received speaker honoraria/consulting fees from Ablative Solutions, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Inari, Medtronic, Merck, ReCor Medical, Servier, and Terumo. Dr Weber has received consulting fees from Medtronic, ReCor, Ablative Solutions, Johnson and Johnson, and Urovant. Dr Schmieder has received grants and personal fees from Medtronic, Recor, and Ablative Solutions. Dr Pocock has received personal fees from Medtronic outside of the submitted work. Dr Tsioufis has received institutional research/grant support from Medtronic and ReCor Medical; and has received personal consulting honoraria from AstraZeneca, Bayer, Boehringer Ingelheim, Medtronic, ReCor Medical, SERVIER, WinMedica, and ELPEN. Dr Konstantinidis receives payments from Medtronic for work as research center secondary investigator. Dr Choi has received consulting fees from Medtronic, outside of the submitted work. Dr East has received consulting fees from Medtronic. Dr Lauder has received speaker fees and honoraria from Medtronic and ReCor Medical. Dr Cohen has received research support and consultant fees from Medtronic and ReCor; and receives fees from Metavention, outside of the submitted work. Dr Kobayashi is on the advisory board and Speakers Bureau for Medtronic and ReCor Medical. Dr Lee has received grants from and serves on the advisory board for Medtronic, outside of the submitted work. Dr Weil has received support from Medtronic, Recor Medical, Novartis, and AstraZeneca. Dr Agdirlioglu receives speaker honoraria from AstraZeneca, Boehringer Ingelheim, and Novartis, outside of the submitted work. Dr Schlaich has received consulting fees and/or travel and research support from Medtronic, Abbott, Novartis, Servier, Pfizer, and Boehringer Ingelheim. Dr Shetty has received consulting and speaker fees from Medtronic. Dr Devireddy has received personal fees from Edwards Lifesciences, Medtronic, ReCor Medical, and Shockwave Medical, outside of the submitted work. Dr Sharp has received personal fees from Medtronic, Boston Scientific, Recor Medical, and Philips, outside the submitted work. Dr Anderson has received speaker fees from Shockwave Medical, Edwards Lifesciences, and Medtronic. Mr Fahy, Mrs DeBruin, and Dr Brar are employees of Medtronic. Dr Böhm is supported by the Deutsche Forschungsgemeinschaft (German Research Foundation; TTR 219, project number 322900939); and has received personal fees from Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Medtronic, Novartis, ReCor, Servier, and Vifor during the conduct of the study. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Comment in

  • The Ongoing Odyssey of Renal Denervation.
    Vinayak M, Olin JW, Stone GW. Vinayak M, et al. J Am Coll Cardiol. 2023 Nov 7;82(19):1824-1827. doi: 10.1016/j.jacc.2023.09.795. J Am Coll Cardiol. 2023. PMID: 37914511 No abstract available.

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