Baroreflex Activation Therapy Lowers Blood Pressure in Patients With Resistant Hypertension
Open accessAbstract
Objectives We sought to determine the effect of baroreflex activation therapy (BAT) on systolic blood pressure (SBP) in patients with resistant hypertension.Background The Rheos Pivotal Trial evaluated BAT for resistant hypertension in a double-blind, randomized, prospective, multicenter, placebo-controlled Phase III clinical trial.Methods This was a double-blind randomized trial of 265 subjects with resistant hypertension implanted and subsequently randomized (2:1) 1 month after implantation. Subjects received either BAT (Group A) for the first 6 months or delayed BAT initiation following the 6-month visit (Group B). The 5 coprimary endpoints were: 1) acute SBP responder rate at 6 months; 2) sustained responder rate at 12 months; 3) procedure safety; 4) BAT safety; and 5) device safety.Results The trial showed significant benefit for the endpoints of sustained efficacy, BAT safety, and device safety. However, it did not meet the endpoints for acute responders or procedural safety. A protocol-specified ancillary analysis showed 42% (Group A) versus 24% (Group B) achieving SBP ≤140 mm Hg at 6 months (p = 0.005), with both groups achieving over 50% at 12 months, at which point Group B had received 6 months of BAT.Conclusions A clinically meaningful measure, those achieving a SBP of ≤140 mm Hg, yielded a significant difference between the groups. The weight of the overall evidence suggests that over the long-term, BAT can safely reduce SBP in patients with resistant hypertension. Future clinical trials will address the limitations of this study and further define the therapeutic benefit of BAT.
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Two device-based therapies targeting the sympathetic nervous system were developed: the surgically implanted barostimulator device and catheter-based renal denervation.
“This was the development of two device-based therapies targeting the sympathetic nervous system, the surgically implanted barostimulator device117 and catheter-based renal denervation20,118.”
From The Sympathetic Nervous System Alterations in Human Hypertension (2015) · cites this paper as [117]
Despite the widespread availability and prescribing of angiotensin converting enzyme-inhibitors, angiotensin receptor blockers, diuretics and calcium channel blockers, in a substantial minority of patients with essential hypertension, perhaps 10%, goal blood pressure was not achieved.
“Despite the widespread availability and prescribing of angiotensin converting enzyme-inhibitors, angiotensin receptor blockers, diuretics and calcium channel blockers, in a substantial minority of patients with essential hypertension, perhaps 10%116, goal blood pressure were not achieved.”
From The Sympathetic Nervous System Alterations in Human Hypertension (2015) · cites this paper as [116]
In a large-scale, double-blind study, the Rheos device was implanted in 265 patients who were subsequently randomised (2:1) to immediate baroreceptor stimulation for the first 6 months (n=181), or deferred stimulation after 6 months (n=84).
“In a large-scale, double-blind study, the Rheos device was implanted in 265 patients who were subsequently randomised (2:1) to immediate baroreceptor stimulation for the first 6 months (n=181), or deferred stimulation after 6 months (n=84)117.”
From The Sympathetic Nervous System Alterations in Human Hypertension (2015) · cites this paper as [117]
At 6 months, blood pressure fell in the group receiving immediate treatment, but the primary efficacy endpoint was not reached, partly because blood pressure likewise decreased in many control subjects.
“At 6 months, blood pressure fell in the group receiving immediate treatment, but the primary efficacy endpoint was not reached, partly because blood pressure likewise decreased in many control subjects117.”
From The Sympathetic Nervous System Alterations in Human Hypertension (2015) · cites this paper as [117]
The first results from a large randomized trial in 322 participants with resistant hypertension failed to meet the primary end point, a composite of 5 individual efficacy and safety end points.
“The first results from a large randomized trial in 322 participants with RH410 failed to meet the primary end point of the trial, a composite of 5 individual efficacy and safety end points.”
From Resistant Hypertension: Detection, Evaluation, and Management: A Scientific Statement From the American Heart Association (2018) · cites this paper as [410]
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- Authors
- Bisognano, J. D., Bakris, G., Nadim, M. K., Sanchez, L., Kroon, A. A., Schafer, J., de Leeuw, P. W., & Sica, D. A.
- Affiliations
- University of Rochester Medicine (US)
- University of Chicago (US)
- University of Southern California (US)
- Maastricht University Medical Centre (NL)
- Virginia Commonwealth University (US)
- Corresponding author
- Bisognano, John D.
- Venue
- Journal of the American College of Cardiology
- Publisher
- Elsevier BV
- Published
- 2011-08
- Volume
- 58
- Issue
- 7
- Pages
- 765-773
- ISSN
- 0735-1097 (ISSN-L)
- OpenAlex
- W167701172
- Cited by
- 600
- References
- 16
- Citations by year
- 2026: 16 · 2025: 18 · 2024: 29 · 2023: 31 · 2022: 20 · 2021: 19 · 2020: 30 · 2019: 32 · 2018: 34 · 2017: 46 · 2016: 53 · 2015: 62 · 2014: 71 · 2013: 61 · 2012: 64
- FWCI
- 45.97
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of the American College of Cardiology (publishedVersion)
- PubMed (publishedVersion)
- Research Publications (Maastricht University) (publishedVersion, other-oa)
- Research Publications (Maastricht University) (submittedVersion, other-oa)
- Funders
- CVRx
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Health Sciences › Medicine › Surgery › Cardiovascular Syncope and Autonomic Disorders
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Rate Variability and Autonomic Control
- Keywords
- baroreflex activation therapy, resistant hypertension, systolic blood pressure, blood pressure reduction, device safety, procedural safety, antihypertensive therapy
- MeSH terms
- Blood Pressure, Carotid Sinus, Double-Blind Method, Electrodes, Implanted, Electric Stimulation Therapy, Female, Humans, Hypertension, Male, Middle Aged, Baroreflex
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