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Pooled Analysis of Ultrasound Renal Denervation for Hypertension
Quick Takes
- Findings from this pooled analysis of individual patient data from three randomized, sham-controlled trials assessing impact of ultrasound renal denervation (uRDN) on blood pressure (BP) reduction shows significant improvement with uRDN compared to sham after 2 months.
- Findings in favor of uRDN persisted regardless of how BP was assessed and across prespecified subgroups. Higher baseline BP, higher heart rate, and presence of orthostatic hypotension were predictors of larger BP response to uRDN.
- Long-term durability, safety, and clinical impact of uRDN as an adjunct therapy for BP management remains to be determined.
Study Questions:
What is the effectiveness and safety of ultrasound renal denervation (uRDN) versus a sham procedure from individual patient-level pooled data across uRDN trials including either patients with mild to moderate hypertension (HTN) on a background of no medications or with hypertension (HTN) resistant to standardized triple-combination therapy?
Methods:
A pooled analysis using individual patient-level data from the ReCor Medical Paradise System in Clinical Hypertension (RADIANCE-HTN SOLO and TRIO) and ReCor Medical Paradise System in Stage II Hypertension (RADIANCE II) trials was performed. Linear regression models were used to compare uRDN with sham across the trials. The primary outcome was baseline-adjusted change in 2-month daytime ambulatory systolic blood pressure (dASBP) between groups.
Results:
A total of 506 patients were randomized in the three studies (uRDN, 293; sham, 213; age, 54.1 [9.3] years; 354 male [70.0%]). After a 1-month medication stabilization period, dASBP was similar between the groups (mean [SD], uRDN, 150.3 [9.2] mm Hg; sham, 150.8 [10.5] mm Hg). At 2 months, dASBP decreased by 8.5 mm Hg to mean (SD) 141.8 (13.8) mm Hg among patients treated with uRDN and by 2.9 mm Hg to 147.9 (14.6) mm Hg among patients treated with a sham procedure (mean difference, −5.9; 95% confidence interval [CI], −8.1 to −3.8 mm Hg; p < 0.001 in favor of uRDN). BP decreases from baseline with uRDN versus sham were consistent across trials and across BP parameters (office SBP: −10.4 mm Hg vs. −3.4 mm Hg; mean difference, −6.4 mm Hg; 95% CI, −9.1 to –3.6 mm Hg; home SBP: −8.4 mm Hg vs. −1.4 mm Hg; mean difference, −6.8 mm Hg; 95% CI, −8.7 to −4.9 mm Hg, respectively). The BP reductions with uRDN versus sham were consistent across prespecified subgroups. Independent predictors of a larger BP response to uRDN were higher baseline BP and heart rate and the presence of orthostatic hypertension. No differences in early safety endpoints were observed between groups.
Conclusions:
Results of this patient-level pooled analysis suggest that BP reductions with uRDN were consistent across HTN severity in sham-controlled trials designed with a 2-month primary endpoint to standardize medications across randomized groups.
Perspective:
Findings from this pooled analysis of individual patient data from three randomized, sham-controlled trials assessing impact of uRDN on BP reduction shows significant improvement with uRDN compared to sham after 2 months. Findings in favor of uRDN persisted regardless of how BP was assessed and across prespecified subgroups. Higher baseline BP, higher heart rate, and presence of orthostatic hypotension were predictors of larger BP response to uRDN. There did not appear to be any short-term safety concerns related to the procedure. Long-term durability, safety, and clinical impact of uRDN as an adjunct therapy for BP management remains to be determined.
Clinical Topics: Noninvasive Imaging, Prevention, Vascular Medicine, Echocardiography/Ultrasound, Hypertension
Keywords: Blood Pressure, Blood Pressure Monitoring, Ambulatory, Denervation, Heart Rate, Hypertension, Hypotension, Orthostatic, Secondary Prevention, Ultrasonography, Interventional, Vascular Diseases
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