Cited by 752Blood Pressure and Hypertension StudiesRenal and Vascular PathologiesCardiovascular Health and Disease Prevention

Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial

Townsend, Raymond R, Mahfoud, Felix, Kandzari, David E, Kario, Kazuomi, Pocock, Stuart, Weber, Michael A, Ewen, Sebastian, Tsioufis, Konstantinos +73 more·2017·The Lancet

Abstract

Background Previous randomised renal denervation studies did not show consistent efficacy in reducing blood pressure. The objective of our study was to evaluate the effect of renal denervation on blood pressure in the absence of antihypertensive medications.Methods SPYRAL HTN-OFF MED was a multicentre, international, single-blind, randomised, sham-controlled, proof-of-concept trial. Patients were enrolled at 21 centres in the USA, Europe, Japan, and Australia. Eligible patients were drug-naive or discontinued their antihypertensive medications. Patients with an office systolic blood pressure (SBP) of 150 mm Hg or greater and less than 180 mm Hg, office diastolic blood pressure (DBP) of 90 mm Hg or greater, and a mean 24-h ambulatory SBP of 140 mm Hg or greater and less than 170 mm Hg at second screening underwent renal angiography and were randomly assigned to renal denervation or sham control. Patients, caregivers, and those assessing blood pressure were blinded to randomisation assignments. The primary endpoint, change in 24-h blood pressure at 3 months, was compared between groups. Drug surveillance was done to ensure patient compliance with absence of antihypertensive medication. The primary analysis was done in the intention-to-treat population. Safety events were assessed at 3 months. This study is registered with ClinicalTrials.gov, number NCT02439749.Findings Between June 25, 2015, and Jan 30, 2017, 353 patients were screened. 80 patients were randomly assigned to renal denervation (n=38) or sham control (n=42) and followed up for 3 months. Office and 24-h ambulatory blood pressure decreased significantly from baseline to 3 months in the renal denervation group: 24-h SBP -5·5 mm Hg (95% CI -9·1 to -2·0; p=0·0031), 24-h DBP -4·8 mm Hg (-7·0 to -2·6; p<0·0001), office SBP -10·0 mm Hg (-15·1 to -4·9; p=0·0004), and office DBP -5·3 mm Hg (-7·8 to -2·7; p=0·0002). No significant changes were seen in the sham-control group: 24-h SBP -0·5 mm Hg (95% CI -3·9 to 2·9; p=0·7644), 24-h DBP -0·4 mm Hg (-2·2 to 1·4; p=0·6448), office SBP -2·3 mm Hg (-6·1 to 1·6; p=0·2381), and office DBP -0·3 mm Hg (-2·9 to 2·2; p=0·8052). The mean difference between the groups favoured renal denervation for 3-month change in both office and 24-h blood pressure from baseline: 24-h SBP -5·0 mm Hg (95% CI -9·9 to -0·2; p=0·0414), 24-h DBP -4·4 mm Hg (-7·2 to -1·6; p=0·0024), office SBP -7·7 mm Hg (-14·0 to -1·5; p=0·0155), and office DBP -4·9 mm Hg (-8·5 to -1·4; p=0·0077). Baseline-adjusted analyses showed similar findings. There were no major adverse events in either group.Interpretation Results from SPYRAL HTN-OFF MED provide biological proof of principle for the blood-pressure-lowering efficacy of renal denervation.Funding Medtronic.

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Authors
Townsend, R. R., Mahfoud, F., Kandzari, D. E., Kario, K., Pocock, S., Weber, M. A., Ewen, S., Tsioufis, K., Tousoulis, D., Sharp, A. S. P., Watkinson, A. F., Schmieder, R. E., Schmid, A., Choi, J. W., East, C., Walton, A., Hopper, I., Cohen, D. L., Wilensky, R., Lee, D. P., Ma, A., Devireddy, C. M., Lea, J. P., Lurz, P. C., Fengler, K., Davies, J., Chapman, N., Cohen, S. A., DeBruin, V., Fahy, M., Jones, D. E., Rothman, M., Böhm, M., Aoki, J., Batson, B., Böhm, M., Choi, J. W., Cohen, D. L., Dangas, G., David, S., Davies, J., Devireddy, C. M., Kandzari, D., Kario, K., Lee, D. P., Lurz, P. C., Patel, M., Patel, K., Schmieder, R. E., Sharp, A. S. P., Singh, J., Tsioufis, K., Walton, A., Weber, T., Weil, J., Zeller, T., Ziada, K., Tanabe, K., Wilkins, R., Mahfoud, F., East, C., Wilensky, R., Contreras, J., Steigerwalt, S., Chapman, N., Lea, J. P., Reedus, D., Hoshide, S., Ma, A., Fengler, K., Svetkey, L., Rao, A., Schmid, A., Watkinson, A. F., Brown, A., Tousoulis, D., Hopper, I., Suppan, M., Agdirlioglu, T., Noory, E., & Chasen, C.
Affiliations
  • University of Pennsylvania (US)
  • Piedmont Atlanta Hospital (US)
  • London School of Hygiene & Tropical Medicine (GB)
  • SUNY Downstate Health Sciences University (US)
  • Saarland University (DE)
  • Barts Health NHS Trust (GB)
  • Stanford Health Care (US)
Corresponding author
Townsend, Raymond R
Venue
The Lancet
Publisher
Elsevier BV
Published
2017-11
Volume
390
Issue
10108
Pages
2160-2170
ISSN
  • 0099-5355 (ISSN-L)
  • 0140-6736
OpenAlex
W2748414916
Cited by
752
References
36
Citations by year
2026: 39 · 2025: 51 · 2024: 60 · 2023: 63 · 2022: 70 · 2021: 90 · 2020: 105 · 2019: 132 · 2018: 111 · 2017: 29
FWCI
79.21
Type
journal article
Language
en
Open access
closed
Locations
  • The Lancet (publishedVersion)
  • PubMed (publishedVersion)
  • LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
  • Royal Devon and Exeter Research Repository (Royal Devon and Exeter) (submittedVersion)
Topics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Renal and Vascular Pathologies
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Health and Disease Prevention
Keywords
renal denervation, catheter ablation, uncontrolled hypertension, antihypertensive medication withdrawal, drug-naive patients, blood pressure reduction, ambulatory blood pressure, office blood pressure, renal sympathetic nerves, treatment safety, adverse events, renal angiography, renal artery stenosis, renal vein stenosis, renal vein thrombosis, renal artery dissection
MeSH terms
Adult, Age Factors, Aged, Antihypertensive Agents, Australia, Blood Pressure Determination, Drug Resistance, Europe, Female, Humans, Hypertension, Male, Middle Aged, Prognosis, Reference Values, Severity of Illness Index, Sex Factors, Sympathectomy, United States, Single-Blind Method, Treatment Outcome, Catheter Ablation, Risk Assessment, Internationality, Patient Safety

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