Abstract
Background
Resistant hypertension (rHTN) is defined as blood pressure (BP) of ≥ 140/90 mmHg despite treatment with at least three antihypertensive medications, including a diuretic. Endovascular ultrasound renal denervation (uRDN) aims to control BP alongside conventional BP treatment with antihypertensive medication. This analysis assesses the cost effectiveness of the addition of the Paradise uRDN System compared with standard of care alone in patients with rHTN from the perspective of the United Kingdom (UK) health care system.
Methods
Using RADIANCE-HTN TRIO trial data, we developed a state-transition model. Baseline risk was calculated using Framingham and Prospective Cardiovascular Münster (PROCAM) risk equations to estimate the long-term cardiovascular risks in patients treated with the Paradise uRDN System, based on the observed systolic BP (SBP) reduction following uRDN. Relative risks sourced from a meta-analysis of randomised controlled trials were then used to project cardiovascular events in patients with baseline SBP (‘control’ patients); utility and mortality inputs and costs were derived from UK data. Costs and outcomes were discounted at 3.5% per annum. Modelled outcomes were validated against trial meta-analyses and the QRISK3 algorithm and real-world evidence of RDN effectiveness. One-way and probabilistic sensitivity analyses were conducted to assess the uncertainty surrounding the model inputs and sensitivity of the model results to changes in parameter inputs. Results were reported as incremental cost-effectiveness ratios (ICERs).
Results
A mean reduction in office SBP of 8.5 mmHg with uRDN resulted in an average improvement in both absolute life-years (LYs) and quality-adjusted life-years (QALYs) gained compared with standard of care alone (0.73 LYs and 0.67 QALYs). The overall base-case ICER with uRDN was estimated at £5600 (€6500) per QALY gained (95% confidence interval £5463–£5739 [€6341–€6661]); modelling demonstrated > 99% probability that the ICER is below the £20,000–£30,000 (€23,214–€34,821) per QALYs gained willingness-to-pay threshold in the UK. Results were consistent across sensitivity analyses and validation checks.
Conclusions
Endovascular ultrasound RDN with the Paradise system offers patients with rHTN, clinicians, and healthcare systems a cost-effective treatment option alongside antihypertensive medication.
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Details
; Bentley, Anthony 2 ; Metcalfe, Kaylie 2 ; Lobo, Melvin D. 3 ; Kirtane, Ajay J. 4 ; Azizi, Michel 5 ; Clark, Christopher 6 ; Murphy, Kieran 7 ; Boer, Jennifer H. 8 ; van Keep, Marjolijn 8 ; Ta, An Thu 8 ; Barman, Neil C. 7 ; Schwab, Garrett 7 ; Akehurst, Ron 9 ; Schmieder, Roland E. 10 1 University of Glasgow, MRC/CSO Social and Public Health Sciences Unit and Robertson Centre for Biostatistics, Institute of Health and Well Being, Glasgow, UK (GRID:grid.8756.c) (ISNI:0000 0001 2193 314X)
2 Mtech Access Limited, Bicester, UK (GRID:grid.8756.c)
3 Queen Mary University of London, Barts NIHR Biomedical Research Centre, William Harvey Research Institute, London, UK (GRID:grid.4868.2) (ISNI:0000 0001 2171 1133)
4 Columbia University Irving Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, USA (GRID:grid.239585.0) (ISNI:0000 0001 2285 2675)
5 Université de Paris, Paris, France (GRID:grid.508487.6) (ISNI:0000 0004 7885 7602); Hôpital Européen Georges-Pompidou, Hypertension Department and DMU CARTE, AP-HP, Paris, France (GRID:grid.414093.b) (ISNI:0000 0001 2183 5849); INSERM, CIC1418, Paris, France (GRID:grid.7429.8) (ISNI:0000 0001 2186 6389)
6 University of Exeter Medical School, Primary Care Research Group, Exeter, UK (GRID:grid.8391.3) (ISNI:0000 0004 1936 8024)
7 ReCor Medical, Palo Alto, USA (GRID:grid.8391.3)
8 BresMed Netherlands, Utrecht, The Netherlands (GRID:grid.8391.3)
9 BresMed Health Solutions, Sheffield, UK (GRID:grid.482857.4) (ISNI:0000 0004 4662 6332); University of Sheffield, Sheffield, UK (GRID:grid.11835.3e) (ISNI:0000 0004 1936 9262)
10 Friedrich Alexander University, Nephrology and Hypertension, University Hospital Erlangen, Erlangen, Germany (GRID:grid.411668.c) (ISNI:0000 0000 9935 6525)





