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Renal Denervation by Iberis Multi-Electrode Renal Denervation System in Patients With Primary Hypertension - Iberis-HTN
Contribution To Literature:
The Iberis-HTN trial showed that in a Chinese cohort of uncontrolled primary HTN despite guideline-directed medical therapy, RDN with the AngioCare RF ablation system resulted in greater reductions in ambulatory SBP and DBP compared with a sham procedure.
Description:
The goal of the trial was to assess the efficacy and safety of the multi-electrode, unipolar AngioCare Iberis renal denervation (RDN) system in patients with treatment-resistant primary hypertension (HTN) on a standardized three-drug regimen.
Study Design
- Multicenter
- Randomized
- Sham-controlled
Patients with uncontrolled HTN were randomized in a 1:1 fashion to undergo RDN (n = 107) or sham renal angiography only (n = 110) via transfemoral arterial access. Randomization was performed after 4 weeks of standardized antihypertensive treatment with amlodipine 5 mg, valsartan 80 mg, and hydrochlorothiazide 12.5 mg daily.
- Total number of enrollees: 217
- Duration of follow-up: 6 months
- Mean patient age: 45 years
- Percentage female: 21%
Inclusion criteria:
- Age 18-65 years
- Primary HTN diagnosis ≥6 months prior
- Office systolic blood pressure (SBP) and diastolic BP (DBP) 150-180 mm Hg and ≥90 mm Hg, respectively
- Mean ambulatory 24-hour SBP 135-170 mm Hg
- Renal artery diameter ≥3 mm and length ≥20 mm on computed tomography angiography
Exclusion criteria:
- Secondary hypertension
- Type 1 diabetes mellitus
- Estimated glomerular filtration rate <45 mL/min/1.73 m2
- Myocardial infarction, syncope, cerebral hemorrhage, or stroke ≤6 months prior
Other salient features/characteristics:
- Mean baseline office BP: 160/100 mm Hg
- Mean procedure time, RDN vs. sham: 69 vs. 27 minutes
- Mean total ablation cycles in RDN arm: 13
Principal Findings:
The primary outcome, change from baseline mean 24-hour ambulatory SBP at 6 months, for RDN vs. sham, was: -13.0 vs. -3.0 mm Hg, between-group difference -9.4 mm Hg (95% confidence interval [CI] -12.9 to -5.9, p < 0.001).
Secondary outcomes at 6 months for RDN vs. sham:
- Change from baseline mean 24-hour ambulatory DBP: -7.7 vs. -2.8 mm Hg, between-group difference -5.0 (95% CI -7.5 to -2.4, p < 0.001)
- Mean number of antihypertensive drugs: 3.0 vs. 3.1 (p = 0.166)
- Percentage achieving office SBP <140 mm Hg: 55.7% vs. 37.7%
Safety events at 6 months for RDN vs. sham:
- All-cause death: 0% vs. 0%
- Access site hematoma: 0.9% vs. 0%
- Renal artery reintervention or stenosis ≥50%: 0% vs. 0%
Interpretation:
The Iberis-HTN trial represents the first randomized trial data supporting the efficacy of RDN as an adjunct to medical antihypertensive therapy in a large cohort of patients of Chinese descent. Treatment differences in BP reduction with RDN were similar to those observed in prior studies of radiofrequency (RF) and ultrasound-based systems, with persistent lowering through the entire 24-hour period of ambulatory monitoring. Procedural safety was also redemonstrated in this study, with only one access site complication in the RDN group. The Iberis RDN catheter is notably compatible with radial access, the comparative efficacy and safety of which is currently being investigated, which should further reduce the risk of procedural complications.
References:
Jiang X, Mahfoud F, Li W, et al. Efficacy and Safety of Catheter-Based Radiofrequency Renal Denervation in Chinese Patients With Uncontrolled Hypertension: The Randomized, Sham-Controlled, Multi-Center Iberis-HTN Trial. Circulation 2024;Sep 4:[Epub ahead of print].
Clinical Topics: Prevention, Hypertension, Invasive Cardiovascular Angiography and Intervention
Keywords: Antihypertensive Agents, Denervation, Hypertension
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