Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2024 May;81(5):1095-1105.
doi: 10.1161/HYPERTENSIONAHA.123.22251. Epub 2024 Feb 5.

Impact of Antihypertensive Medication Changes After Renal Denervation Among Different Patient Groups: SPYRAL HTN-ON MED

Raymond R Townsend  1 , Keith C Ferdinand  2 , David E Kandzari  3 , Kazuomi Kario  4 , Felix Mahfoud  5 , Michael A Weber  6 , Roland E Schmieder  7 , Stuart Pocock  8 , Konstantinos Tsioufis  9 , Shukri David  10 , Susan Steigerwalt  10 , Antony Walton  11 , Ingrid Hopper  11 , Barry Bertolet  12 , Faisal Sharif  13 , Karl Fengler  14 , Martin Fahy  15 , Douglas A Hettrick  15 , Sandeep Brar  15 , Michael Böhm  5
Affiliations
Randomized Controlled Trial

Impact of Antihypertensive Medication Changes After Renal Denervation Among Different Patient Groups: SPYRAL HTN-ON MED

Raymond R Townsend et al. Hypertension. 2024 May.

Abstract

Background: The SPYRAL HTN-ON MED (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)trial showed significant office and nighttime systolic blood pressure (BP) reductions in patients with hypertension following renal denervation (RDN) compared with sham-control patients, despite similar 24-hour BP reductions. We compared antihypertensive medication and BP changes among prespecified subpopulations.

Methods: The multicenter, randomized, sham-controlled, blinded SPYRAL HTN-ON MED trial (n=337) evaluated BP changes after RDN compared with a sham procedure in patients with hypertension prescribed 1 to 3 antihypertensive drugs. Most patients (n=187; 54%) were enrolled outside the United States, while 156 (46%) US patients were enrolled, including 60 (18%) Black Americans.

Results: Changes in detected antihypertensive drugs were similar between RDN and sham group patients in the outside US cohort, while drug increases were significantly more common in the US sham group compared with the RDN group. Patients from outside the United States showed significant reductions in office and 24-hour mean systolic BP at 6 months compared with the sham group, whereas BP changes were similar between RDN and sham in the US cohort. Within the US patient cohort, Black Americans in the sham control group had significant increases in medication burden from baseline through 6 months (P=0.003) but not in the RDN group (P=0.44).

Conclusions: Patients enrolled outside the United States had minimal antihypertensive medication changes between treatment groups and had significant office and 24-hour BP reductions compared with the sham group. Increased antihypertensive drug burden in the US sham cohort, especially among Black Americans, may have diluted the treatment effect in the combined trial population.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02439775.

Keywords: Black or African American; antihypertensive agents; blood pressure; hypertension; renal denervation.

PubMed Disclaimer

Conflict of interest statement

Disclosures R.R. Townsend is a consultant for Medtronic, Cytel, Novartis, Regeneron, and Janssen. He also receives royalties from UpToDate. K.C. Ferdinand is a consultant for Medtronic, Novartis, and Janssen. D.E. Kandzari reports institutional research/grant support from Biotronik, Boston Scientific, Cardiovascular Systems, Inc, Orbus Neich, Teleflex, Medtronic, and Ablative Solutions and personal consulting honoraria from Cardiovascular Systems, Inc, Medtronic, and Abbott Vascular. K. Kario receives personal fees from Medtronic during the conduct of the study; grants from A&D, Omron Healthcare, Fukuda Denshi, CureApp, Sanwa Kagaku Kenkyusho, Teijin Pharma, Boehringer Ingelheim Japan, and Fukuda Lifetec; consulting fees from A&D, JIMRO, Omron Healthcare, CureApp, Terumo, and Fukuda Denshi; honoraria from Otsuka Pharmaceuticals and Omron Healthcare; and participation in Advisory Board of Fukuda Denshi, outside the submitted work. F. Mahfoud is supported by Deutsche Gesellschaft für Kardiologie, Deutsche Forschungsgemeinschaft (SFB TRR219), and Deutsche Herzstiftung. He has received scientific support from Ablative Solutions, Medtronic, and ReCor Medical and speaker honoraria/consulting fees from Ablative Solutions, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Inari, Medtronic, Merck, ReCor Medical, Servier, and Terumo. M.A. Weber has received consulting fees from Medtronic, ReCor Medical, Ablative Solutions, Johnson & Johnson, and Urovant. R.E. Schmieder reports grants and personal fees from Medtronic, ReCor Medical, and Ablative Solutions. S. Pocock reports personal fees from Medtronic outside the submitted work. K. Tsioufis reports institutional research/grant support from Medtronic and ReCor Medical and personal consulting honoraria from AstraZeneca, Bayer, Boehringer Ingelheim, Medtronic, ReCor Medical, Servier, WinMedica, and ELPEN. A. Walton is a proctor, on the medical advisory board, and has received grant support from Medtronic, Edwards, and Abbott. I. Hopper has received honoraria from Boehringer Ingelheim, Eli Lilly, AstraZeneca, and Vifor. B. Bertolet serves on the Medtronic Renal Denervation Advisory Committee as a consultant. F. Sharif is supported by Science Foundation Ireland Research Infrastructure (17/RI/5353) and is a consultant and advisory board member for Medtronic. K. Fengler received institutional grants from Medtronic, ReCor Medical, and Biotronic. M. Fahy, D.A. Hettrick, and S. Brar are employees of Medtronic. M. Böhm is supported by the Deutsche Forschungsgemeinschaft (German Research Foundation; TTR 219, project number 322900939) and reports personal fees from Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Medtronic, Novartis, ReCor Medical, Servier, and Vifor during the conduct of the study. The other authors report no conflicts.

Figures

Figure 1.
Figure 1.
Twenty-four-hour systolic blood pressure (SBP) and office SBP forest plots of prespecified subgroups. BMI indicates body mass index; BP, blood pressure; and RDN, renal denervation.
Figure 2.
Figure 2.
Medication burden change from baseline to 6 months based on medication testing comparing renal denervation (RDN) and sham control groups in US patients and patients outside the United States as well as Black Americans and non-Black Americans. P values use the Mantel-Haenszel test for linear trend. Reported changes detected by blood and urine testing are based on the medication number, dosage, and class of antihypertensive medications.
Figure 3.
Figure 3.
Changes in prescribed medication burden from baseline to 6 months in renal denervation (RDN) and sham control groups among Black Americans, non-Black Americans, and patients outside the United States.
Figure 4.
Figure 4.
Reduction in mean 24-hour ambulatory and office systolic blood pressure (SBP) at 6 months for renal denervation (RDN) and sham control groups among Black Americans, non-Black Americans, and patients outside the United States.
Figure 5.
Figure 5.
Change in office systolic blood pressure (BP) from baseline up to 6 months in select subgroups of renal denervation and sham control patients Mean office systolic blood pressure changes are depicted through 6 months in Black American patients (A), non-Black American patients (B), and patients outside the United States (C) in renal denervation (blue) and sham control groups (red). Error bars represent SE.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Zhou B, Carrillo-Larco RM, Danaei G, Riley LM, Paciorek CJ, Stevens GA, Gregg EW, Bennett JE, Solomon B, Singleton RK, et al. . Worldwide trends in hypertension prevalence and progress in treatment and control from 1990 to 2019: a pooled analysis of 1201 population-representative studies with 104 million participants. Lancet. 2021;398:957–980. doi: 10.1016/S0140-6736(21)01330-1 - PMC - PubMed
    1. Mills KT, Stefanescu A, He J. The global epidemiology of hypertension. Nat Rev Nephrol. 2020;16:223–237. doi: 10.1038/s41581-019-0244-2 - PMC - PubMed
    1. Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Delling FN, et al. . Heart disease and stroke statistics—2020 update: a report from the American Heart Association. Circulation. 2020;141:e139–e596. doi: 10.1161/CIR.0000000000000757 - PubMed
    1. Muntner P, Hardy ST, Fine LJ, Jaeger BC, Wozniak G, Levitan EB, Colantonio LD. Trends in blood pressure control among US adults with hypertension, 1999-2000 to 2017-2018. JAMA. 2020;324:1190–1200. doi: 10.1001/jama.2020.14545 - PMC - PubMed
    1. Aggarwal R, Chiu N, Wadhera RK, Moran AE, Raber I, Shen C, Yeh RW, Kazi DS. Racial/ethnic disparities in hypertension prevalence, awareness, treatment, and control in the United States, 2013 to 2018. Hypertension. 2021;78:1719–1726. doi: 10.1161/HYPERTENSIONAHA.121.17570 - PMC - PubMed

Publication types

Substances

Associated data