Three-Arm Randomized Trial of Different Renal Denervation Devices and Techniques in Patients With Resistant Hypertension - RADIOSOUND-HTN

Sep 25, 2018
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Leipzig Heart Institute; ReCor Medical
Date Presented:
09/25/2018
Date Published:
09/25/2018
Date Updated:
09/25/2018
Original Posted Date:
09/25/2018
References

Contribution To Literature:

The RADIOSOUND-HTN trial showed that among patients with resistant hypertension, RDN using the Paradise endovascular ultrasound RDN system resulted in a greater reduction in ambulatory SBP at 3 months compared with radiofrequency ablation of the main renal artery alone, but not over radiofrequency ablation of the side branches in addition to the main artery.

Description:

The goal of the trial was to compare the effectiveness of three different strategies for renal denervation (RDN) among patients with resistant hypertension.

Study Design

Patients with resistant hypertension were randomized in a 1:1:1 manner to receive either treatment with radiofrequency RDN of the main renal arteries (RFM-RDN) (n = 39) vs. radiofrequency RDN of the main renal arteries, side branches, and accessories (RFB-RDN) (n = 39) vs. endovascular ultrasound-based RDN of the main renal artery (USM-RDN) (n = 42). For radiofrequency ablation, the multipolar Symplicity Spyral catheter was used (Medtronic). In the RFM-RDN group, multiple ablation runs of 1 minute were delivered to the main renal artery from distal to proximal. In the RFB-RDN group, the main renal arteries, any side branch >3.0 mm, as well as all accessory renal arteries >3.0 mm were treated, with lesion distribution from distal to proximal. Ultrasound RDN was performed using the Paradise catheter (ReCor Medical). USM-RDN was conducted in the main renal artery only.

  • Total number of enrollees: 120
  • Duration of follow-up: 3 months
  • Mean patient age: 63.5 years
  • Percentage female: 31%

Inclusion criteria:

  • Resistant hypertension with systolic daytime blood pressure (BP) >135 mm Hg on ambulatory BP monitoring, despite treatment with ≥3 different classes of antihypertensive drugs on ≥50% of maximum dosage for hypertension including ≥1 diuretic
  • Stable antihypertension medications for 4 weeks
  • Renal artery diameter of ≥1 main renal artery ≥5.5 mm

Exclusion criteria:

  • Ambulatory BP monitoring suggestive of white coat hypertension
  • Age <18 or >75 years
  • Pregnancy
  • Life-expectancy <6 months
  • Evidence for secondary hypertension
  • Participation in any other randomized clinical trial
  • Known renal artery stenosis or anatomy unsuitable for interventional RDN
  • Any main renal artery diameter <4.0 mm
  • Inadequate medication adherence per patient’s primary care physician

Other salient features/characteristics:

  • Estimated glomerular filtration rate: 77.4
  • Renal artery diameter: 5.8-6 mm
  • Oral anticoagulation: 21%
  • Number of antihypertensive medications: 5.0
  • Use of mineralocorticoid receptor antagonists: 23%
  • Median contrast use: 110.6 mm
  • Daytime BP on ambulatory monitor: 153.1/86.3 mm Hg

Principal Findings:

The primary outcome, change in daytime ambulatory systolic BP (SBP) at 3 months, in RFM-RDN vs. RFB-RDN vs. USM-RDN: -6.5 mm Hg vs. -8.3 mm Hg vs. -13.2 mm Hg (p = 0.038). Differences between RFM-RDN and USM-RDN were significant (adjusted p = 0.043).

Secondary outcomes for RFM-RDN vs. RFB-RDN vs. USM-RDN:

  • SBP response ≥5 mm Hg: 66% vs. 73% vs. 67%, p = 0.77
  • Night-time ambulatory SBP at 3 months: -2.1 mm Hg vs. -5.1 mm Hg vs. -10.2 mm Hg, p = 0.043
  • Increase in medication use: 3 vs. 5 vs. 1 patient(s)

Interpretation:

The results of this trial indicate that, among patients with resistant hypertension, RDN using the Paradise endovascular ultrasound RDN system resulted in a greater reduction in ambulatory SBP at 3 months compared with RFM-RDN, but not RFB-RDN. Ideally, a sham group should have been included in this study. It is postulated that this difference may be due to deeper penetration of energy delivered and more complete sympathetic ablation with ultrasound-based denervation. Regression to the mean is an important consideration in hypertension trials, and thus, these results need to be replicated in a larger cohort with longer follow-up. The results with the ultrasound-based technique have shown similar promising early results in patients with mild to moderate hypertension (RADIANCE-HTN SOLO trial).

References:

Fengler K, Rommel KP, Blazek S, et al. A Three-Arm Randomized Trial of Different Renal Denervation Devices and Techniques in Patients With Resistant Hypertension (RADIOSOUND-HTN). Circulation 2018;Sep 25:[Epub ahead of print].

Presented by Dr. Philipp Lurz at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2018), San Diego, CA, September 25, 2018.

Clinical Topics: Arrhythmias and Clinical EP, Noninvasive Imaging, Prevention, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Interventions and Imaging, Echocardiography/Ultrasound, Hypertension

Keywords: TCT18, Transcatheter Cardiovascular Therapeutics, Antihypertensive Agents, Blood Pressure, Blood Pressure Monitoring, Ambulatory, Hypertension, Catheter Ablation, Denervation, Diuretics, Endovascular Procedures, Hypertension, Primary Prevention, Renal Artery, Ultrasonography, Vascular Diseases


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