Systematic Review of Renal Denervation for Uncontrolled Hypertension: Meta-Analysis Results for Office and 24-Hour Ambulatory Blood Pressure

Author(s)

Sanderson A1, Hansell N1, Reddish K1, Moss J1, Schmieder RE2, Strachan L3, Walleser Autiero S4, Sharp A5, Marshall CV1
1York Health Economics Consortium, York, UK, 2Universitätsklinikum Erlangen, Erlangen, Germany, 3Medtronic, Macquarie Park, NSW, Australia, 4Medtronic International Trading Sarl, Tolochenaz, Switzerland, 5University Hospital of Wales, Cardiff, Wales, UK

OBJECTIVES: Hypertension remains a significant clinical and public health challenge as a leading cause of morbidity and mortality worldwide. Renal denervation (RDN) is a procedure that aims to treat uncontrolled hypertension, including resistant hypertension. The objective of this systematic review (SR) and meta-analyses (MA) was to assess the efficacy of RDN compared with no RDN or sham control in patients with uncontrolled hypertension.

METHODS: A SR, adhering to Cochrane and PRISMA guidance, was undertaken to identify randomised controlled trials (RCTs) of ultrasound or radiofrequency, catheter-based RDN. Eligible RCTs included adult patients with uncontrolled hypertension (office blood pressure ≥140/90mmHg, with/without any previous baseline antihypertensive medication). Key outcomes included office and 24-hour ambulatory blood pressure change from baseline. A feasibility assessment was conducted to assess the suitability of included trials for MA. Random effects (RE) MAs were conducted at the primary endpoint and last reported follow-up. The robustness of these results was assessed in a series of sensitivity and subgroup analyses.

RESULTS: Searches conducted between November 2022 and May 2023 identified 6,298 records. Following screening, 25 RCTs were included. Four trials classified as “off-med” (trials in patients not receiving antihypertensive medication) and 12 trials as “on-med” (patients receiving the same regimen of antihypertensive medication) were suitable for MA. A RE MA for office systolic blood pressure (SBP) estimated a mean difference of -8.5 (95% CI: -13.4 to -3.5) at the primary endpoint and -7.2 (95% CI: -12.5 to -2.0) at last follow-up between RDN and the control group. For 24-hour ambulatory SBP, the mean difference was -3.7 (95% CI: -5.3 to -2.0) and -3.3 (95% CI: -5.0 to -1.6) at the primary endpoint and last follow-up respectively.

CONCLUSIONS: There is robust evidence to suggest that RDN is effective in achieving clinically meaningful blood pressure reductions compared to no RDN or sham among patients with uncontrolled hypertension.

Conference/Value in Health Info

2023-11, ISPOR Europe 2023, Copenhagen, Denmark

Value in Health, Volume 26, Issue 11, S2 (December 2023)

Code

MT1

Topic

Clinical Outcomes, Medical Technologies, Study Approaches

Topic Subcategory

Comparative Effectiveness or Efficacy, Literature Review & Synthesis, Medical Devices

Disease

Cardiovascular Disorders (including MI, Stroke, Circulatory), Medical Devices

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