Europe PMC
Nothing Special   »   [go: up one dir, main page]

Europe PMC requires Javascript to function effectively.

Either your web browser doesn't support Javascript or it is currently turned off. In the latter case, please turn on Javascript support in your web browser and reload this page.

This website requires cookies, and the limited processing of your personal data in order to function. By using the site you are agreeing to this as outlined in our privacy notice and cookie policy.

Patient-Level Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure 6 Months After Medication Escalation: The RADIANCE Clinical Trial Program.

Show less

Collaborators (590)

Author information

Affiliations

  • 1. Université Paris Cité, France (M.A.).
      Authors
    • Azizi M 1
    (1 author)
  • 2. University Hospital of Wales and Cardiff University, Cardiff, UK (A.S.P.S.).
      Authors
    • Sharp ASP 2
    (1 author)
  • 3. The Brigham and Women's Hospital, Boston, MA (N.D.L.F.).
      Authors
    • Fisher NDL 3
    (1 author)
  • 4. Division of Cardiovascular Medicine, State University of New York, Downstate Medical Center, New York (M.A.W., M.S.).
      Authors
    • Weber MA 4
    • Saxena M 4
    (2 authors)
  • 5. Barts NIHR Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, UK (M.D.L.).
      Authors
    • Lobo MD 5
    (1 author)
    • Show all (20)

ORCIDs linked to this article

Show all (17)

Circulation, 26 Oct 2023, 149(10):747-759
https://doi.org/10.1161/circulationaha.123.066941 PMID: 37883784 

A comment on this article appears in "The Next Chapter of Renal Denervation After US Food and Drug Administration Approval." Circulation. 2024 Mar 5;149(10):760-763.

Abstract 

Background

The randomized, sham-controlled RADIANCE-HTN (A Study of the Recor Medical Paradise System in Clinical Hypertension) SOLO, RADIANCE-HTN TRIO, and RADIANCE II (A Study of the Recor Medical Paradise System in Stage II Hypertension) trials independently met their primary end point of a greater reduction in daytime ambulatory systolic blood pressure (SBP) 2 months after ultrasound renal denervation (uRDN) in patients with hypertension. To characterize the longer-term effectiveness and safety of uRDN versus sham at 6 months, after the blinded addition of antihypertensive treatments (AHTs), we pooled individual patient data across these 3 similarly designed trials.

Methods

Patients with mild to moderate hypertension who were not on AHT or with hypertension resistant to a standardized combination triple AHT were randomized to uRDN (n=293) versus sham (n=213); they were to remain off of added AHT throughout 2 months of follow-up unless specified blood pressure (BP) criteria were exceeded. In each trial, if monthly home BP was ≥135/85 mm Hg from 2 to 5 months, standardized AHT was sequentially added to target home BP <135/85 mm Hg under blinding to initial treatment assignment. Six-month outcomes included baseline- and AHT-adjusted change in daytime ambulatory, home, and office SBP; change in AHT; and safety. Linear mixed regression models using all BP measurements and change in AHT from baseline through 6 months were used.

Results

Patients (70% men) were 54.1±9.3 years of age with a baseline daytime ambulatory/home/office SBP of 150.5±9.8/151.0±12.4/155.5±14.4 mm Hg, respectively. From 2 to 6 months, BP decreased in both groups with AHT titration, but fewer uRDN patients were prescribed AHT (P=0.004), and fewer additional AHT were prescribed to uRDN patients versus sham patients (P=0.001). Whereas the unadjusted between-group difference in daytime ambulatory SBP was similar at 6 months, the baseline and medication-adjusted between-group difference at 6 months was -3.0 mm Hg (95% CI, -5.7, -0.2; P=0.033), in favor of uRDN+AHT. For home and office SBP, the adjusted between-group differences in favor of uRDN+AHT over 6 months were -5.4 mm Hg (-6.8, -4.0; P<0.001) and -5.2 mm Hg (-7.1, -3.3; P<0.001), respectively. There was no heterogeneity between trials. Safety outcomes were few and did not differ between groups.

Conclusions

This individual patient-data analysis of 506 patients included in the RADIANCE trials demonstrates the maintenance of BP-lowering efficacy of uRDN versus sham at 6 months, with fewer added AHTs.

Registration

URL: https://www.clinicaltrials.gov; Unique identifiers: NCT02649426 and NCT03614260.

Full text links 

Read article at publisher's site: https://doi.org/10.1161/circulationaha.123.066941

Read article for free, from open access legal sources, via Unpaywall: https://www.ahajournals.org/doi/pdf/10.1161/CIRCULATIONAHA.123.066941Unpaywall

Citations & impact 

Impact metrics

4
Citations
Jump to Citations

Citations of article over time

Alternative metrics

Altmetric item for https://www.altmetric.com/details/155789191
Altmetric
Discover the attention surrounding your research
https://www.altmetric.com/details/155789191

Smart citations by scite.ai
Smart citations by scite.ai include citation statements extracted from the full text of the citing article. The number of the statements may be higher than the number of citations provided by EuropePMC if one paper cites another multiple times or lower if scite has not yet processed some of the citing articles.
Explore citation contexts and check if this article has been supported or disputed.
https://scite.ai/reports/10.1161/circulationaha.123.066941

Supporting
Mentioning
Contrasting
0
6
0

Article citations

Data 

Data behind the article

This data has been text mined from the article, or deposited into data resources.

Clinical Trials (2)

Similar Articles 

To arrive at the top five similar articles we use a word-weighted algorithm to compare words from the Title and Abstract of each citation.

Funding 

Funders who supported this work.

ReCor Medical