Cited by 2,186Blood Pressure and Hypertension StudiesRenal and Vascular PathologiesCardiovascular Health and Disease Prevention

A Controlled Trial of Renal Denervation for Resistant Hypertension

Bhatt, Deepak L., Kandzari, David E., O'Neill, William W., D'Agostino, Ralph, Flack, John M., Katzen, Barry T., Leon, Martin B., Liu, Minglei +7 more·2014·New England Journal of Medicine

Abstract

BACKGROUND: Prior unblinded studies have suggested that catheter-based renal-artery denervation reduces blood pressure in patients with resistant hypertension. METHODS: We designed a prospective, single-blind, randomized, sham-controlled trial. Patients with severe resistant hypertension were randomly assigned in a 2:1 ratio to undergo renal denervation or a sham procedure. Before randomization, patients were receiving a stable antihypertensive regimen involving maximally tolerated doses of at least three drugs, including a diuretic. The primary efficacy end point was the change in office systolic blood pressure at 6 months; a secondary efficacy end point was the change in mean 24-hour ambulatory systolic blood pressure. The primary safety end point was a composite of death, end-stage renal disease, embolic events resulting in end-organ damage, renovascular complications, or hypertensive crisis at 1 month or new renal-artery stenosis of more than 70% at 6 months. RESULTS: A total of 535 patients underwent randomization. The mean (±SD) change in systolic blood pressure at 6 months was -14.13±23.93 mm Hg in the denervation group as compared with -11.74±25.94 mm Hg in the sham-procedure group (P<0.001 for both comparisons of the change from baseline), for a difference of -2.39 mm Hg (95% confidence interval [CI], -6.89 to 2.12; P=0.26 for superiority with a margin of 5 mm Hg). The change in 24-hour ambulatory systolic blood pressure was -6.75±15.11 mm Hg in the denervation group and -4.79±17.25 mm Hg in the sham-procedure group, for a difference of -1.96 mm Hg (95% CI, -4.97 to 1.06; P=0.98 for superiority with a margin of 2 mm Hg). There were no significant differences in safety between the two groups. CONCLUSIONS: This blinded trial did not show a significant reduction of systolic blood pressure in patients with resistant hypertension 6 months after renal-artery denervation as compared with a sham control. (Funded by Medtronic; SYMPLICITY HTN-3 ClinicalTrials.gov number, NCT01418261.).

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Crossref · 10.1056/nejmoa1402670

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  • The first randomized, sham-controlled renal denervation trial, SYMPLICITY HTN-3, failed to prove superiority of renal denervation for blood pressure lowering compared with a sham control procedure.

    “The first randomized, sham-controlled RDN trial, SYMPLICITY HTN-3, failed to prove superiority of RDN for BP lowering compared with a sham control procedure165.”
  • SYMPLICITY HTN-3 was five times larger than the first two SYMPLICITY renal denervation trials and incorporated a blinded sham design.

    “Five times larger than the first two SYMPLICITY renal denervation trials, and incorporating a blinded sham design”
  • In the SYMPLICITY HTN-3 trial, the primary efficacy endpoint was not reached.

    “indicating that the primary efficacy endpoint had not been reached in the trial.”
  • The first sham-controlled prospective randomized study in renal ablation therapy, SYMPLICITY HTN-3, showed little to no effect of renal denervation therapy in a severely drug treatment-resistant population.

    “The first sham-controlled prospective randomized study in the field of renal ablation therapy, SYMPLICITY HTN-3, showed little to no effect of renal denervation therapy in a severely drug treatment-resistant population.404”
  • In a recent blinded, sham-controlled study (SYMPLICITY HTN-3), after 6 months, the blood pressure lowering effect of renal denervation was not significantly different from that observed in the sham group.

    “Moreover, in a recent blinded, sham-controlled study (SYMPLICITY HTN-3), after 6 months, the blood pressure lowering effect of renal denervation was not significantly different from that observed in the sham group (30).”

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Authors
Bhatt, D. L., Kandzari, D. E., O'Neill, W. W., D'Agostino, R., Flack, J. M., Katzen, B. T., Leon, M. B., Liu, M., Mauri, L., Negoita, M., Cohen, S. A., Oparil, S., Rocha-Singh, K., Townsend, R. R., & Bakris, G. L.
Affiliations
  • Boston University (US)
  • Piedmont Atlanta Hospital (US)
  • Wayne State University (US)
  • Baptist Hospital of Miami (US)
  • NewYork–Presbyterian Hospital (US)
  • Brigham and Women's Hospital (US)
  • University of Pennsylvania (US)
  • University of Alabama at Birmingham (US)
  • University of Chicago (US)
Venue
New England Journal of Medicine
Published
2014-04-10
Volume
370
Issue
15
Pages
1393-1401
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2133088349
Cited by
2,186
References
27
Citations by year
2026: 76 · 2025: 86 · 2024: 104 · 2023: 114 · 2022: 112 · 2021: 127 · 2020: 142 · 2019: 159 · 2018: 183 · 2017: 222 · 2016: 260 · 2015: 332 · 2014: 262 · 2013: 1
FWCI
245.98
Type
journal article
Language
en
Open access
closed
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
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
resistant hypertension, blood pressure reduction, ambulatory blood pressure, end-stage renal disease, embolic events, hypertensive crisis, renal artery stenosis
MeSH terms
Aged, Blood Pressure, Denervation, Female, Humans, Hypertension, Male, Middle Aged, Placebos, Radiography, Renal Artery, Single-Blind Method, Treatment Failure, Intention to Treat Analysis

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