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The review from Marcusohn et al (1) provides an excellent overview of the science and evidence for renal denervation (RDN) in hypertension. We would like to add some more nuance for the journal readers to appreciate before embracing denervation into practice. The two final phase 3 trials of denervation did not demonstrate efficacy for the primary outcome of sham controlled change in 24-hour ambulatory blood pressure (ABPM), which is not apparent in the bar graphs from figure 2. The treatment difference in the mean systolic ABPM from baseline to 6 months between the RDN and sham control was −1.9 mm Hg (95% CI: −4.4 to 0.5 mm Hg; P = 0.12) in the SPYRAL trial (2) and −1.9 mm Hg (95% CI −4.8 to 1.0, P = 0.33) in the RADIANCE trial (3). Much of the attenuation in the difference was because of effective BP lowering in the sham control group with BP lowering medications. In Canada, all BP lowering medications are inexpensive, costing pennies per day, and much cheaper than the (expected) $10 000 to 15 000 per procedure RDN cost. There is a cost-effectiveness analysis from the UK which reports an incremental cost-effectiveness ratio (ICER) of £13 482 per quality of life year (QALY) gained, however uses a difference of office systolic BP (- 4.9 mm Hg) and not the much lower and rigorous ABPM (- 1.9 mm Hg) in their model (4). The candidacy of potentially eligible patients mentioned in the article by Marcusohn et al is also different from the eligibility from the trials (e.g. prese...
Show MoreCompeting Interests: None declared.References
- 1. Marcusohn E, Tobe SW, Dueck A, et al. Renal denervation for uncontrolled hypertension. CMAJ 2023;195:E1475-E1480
- 2. Kandzari DE, Townsend RR, Kario K, et al. Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications. J Am Coll Cardiol 2023;82:1809-23.
- 3. Azizi M, Sharp ASP, Fisher NDL, et al. Patient-Level Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure 6 Months After Medication Escalation: The RADIANCE Clinical Trial Program. Circulation 2024;149:747-59.
- 4. Sharp ASP, Cao KN, Esler MD, et al. Cost-effectiveness of catheter-based radiofrequency renal denervation for the treatment of uncontrolled hypertension: an analysis for the UK based on recent clinical evidence. Eur Heart J Qual Care Clin Outcomes 2024