Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications

J Am Coll Cardiol. 2023 Nov 7;82(19):1809-1823. doi: 10.1016/j.jacc.2023.08.045.

Abstract

Background: Renal denervation (RDN) reduces blood pressure (BP) in patients with uncontrolled hypertension in the absence of antihypertensive medications.

Objectives: This trial assessed the safety and efficacy of RDN in the presence of antihypertensive medications.

Methods: SPYRAL HTN-ON MED is a prospective, randomized, sham-controlled, patient- and assessor-blinded trial enrolling patients from 56 clinical centers worldwide. Patients were prescribed 1 to 3 antihypertensive medications. Patients were randomized to radiofrequency RDN or sham control procedure. The primary efficacy endpoint was the baseline-adjusted change in mean 24-hour ambulatory systolic BP at 6 months between groups using a Bayesian trial design and analysis.

Results: The treatment difference in the mean 24-hour ambulatory systolic BP from baseline to 6 months between the RDN group (n = 206; -6.5 ± 10.7 mm Hg) and sham control group (n = 131; -4.5 ± 10.3 mm Hg) was -1.9 mm Hg (95% CI: -4.4 to 0.5 mm Hg; P = 0.12). There was no significant difference between groups in the primary efficacy analysis with a posterior probability of superiority of 0.51 (Bayesian treatment difference: -0.03 mm Hg [95% CI: -2.82 to 2.77 mm Hg]). However, there were changes and increases in medication intensity among sham control patients. RDN was associated with a reduction in office systolic BP compared with sham control at 6 months (adjusted treatment difference: -4.9 mm Hg; P = 0.0015). Night-time BP reductions and win ratio analysis also favored RDN. There was 1 adverse safety event among 253 assessed patients.

Conclusions: There was no significant difference between groups in the primary analysis. However, multiple secondary endpoint analyses favored RDN over sham control. (SPYRAL HTN-ON MED Study [Global Clinical Study of Renal Denervation With the Symplicity Spyral Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications]; NCT02439775).

Keywords: Bayesian trial; antihypertensive medications; renal denervation; uncontrolled hypertension; win ratio.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antihypertensive Agents* / pharmacology
  • Antihypertensive Agents* / therapeutic use
  • Bayes Theorem
  • Blood Pressure
  • Blood Pressure Monitoring, Ambulatory
  • Denervation / methods
  • Humans
  • Hypertension* / drug therapy
  • Hypertension* / surgery
  • Kidney
  • Prospective Studies
  • Sympathectomy / methods
  • Treatment Outcome

Substances

  • Antihypertensive Agents

Associated data

  • ClinicalTrials.gov/NCT02439775