1. In this patient-level pooled analysis of 3 randomized clinical trials, among 506 patients with hypertension, a greater reduction in daytime ambulatory systolic blood pressure (SBP) was observed in patients receiving ultrasound renal denervation (uRDN), compared with sham at 2 months, consistent across all trials.
2. At 2 months, daytime ambulatory SBP decreased by 8.5 mmHg to 141.8 mmHg among patients treated with uRDN and by 2.9 mmHg to 147.9 mmHg among patients treated with a sham procedure.
Evidence Rating Level:1 (Excellent)
Study Rundown: Uncontrolled hypertension continues to be a leading cause of cardiovascular morbidity and mortality globally. As such, various device-based interventions and their effects on lowering BP are being investigated. In particular, endovascular renal denervation has emerged as an approach to lowering BP. This study aimed to characterize the effectiveness and safety of uRDN vs a sham procedure from individual patient-level pooled data across 3 uRDN trials (SOLO, TRIO and RADIANCE II), including patients with hypertension not being treated with antihypertensive medications. The primary outcome was 2-month daytime ambulatory SBP between groups. A total of 506 patients were included and randomized in the three studies (uRDN, 293; sham, 213). 2 months, daytime ambulatory SBP decreased from the pre-randomization baseline by 8.5 mmHg to 141.8 mmHg among patients treated with uRDN, and by 2.9 mmHg to 147.9 mmHg among patients treated with a sham procedure. Reductions in SBP were consistent across all 3 included trials. Independent predictors of a more significant change in BP in response to uRDN included higher baseline BP and heart rate and the presence of orthostatic hypertension. A strength of this study was the inclusion of 3 trials in the pooled analysis. A limitation, however, was the findings were restricted to a 2-month follow-up period, corresponding to the ascertainment of the primary study endpoints.
Click to read the study in JAMA Cardiology
Click to read an accompanying editorial in JAMA Cardiology
Relevant Reading: Effects of renal denervation on kidney function and long-term outcomes: 3-year follow-up from the Global SYMPLICITY Registry
In-Depth [randomized controlled trial]: This study conducted a patient-level pooled analysis to characterize the effectiveness and safety of uRDN vs a sham procedure across uRDN trials, including patients with mild to moderate hypertension on no medications or with hypertension resistant to standard therapy. Data sources included the RADIANCE-HTN SOLO and TRIO trial and the RADIANCE II trial. uRDN and sham were compared using a pooled analysis using individual patient-level data using linear regression models. The primary outcome was the baseline-adjusted change in 2-month daytime ambulatory systolic BP. A total of 506 patients were randomized within the three studies (uRDN, 293; sham 213; mean [SD] age, 54.1 [9.3]; 354 male [70.0%]). At two months, daytime ambulatory SBP decreased by 8.5 mmHg to mean (SD)141.8 (13.8) mmHg among patients treated with uRDN, and by 2.9 mmHg to 147.9 mmHg (14.6) among patients treated with a sham procedure (mean difference, -5.9; 95% CI, -8.1 to -3.8 mmHg; P < .001 in favour of uRDN). Decreases in BP from baseline were found to be consistent across trials and BP parameters (office SBP: -10.4 mmHg vs -3.4mmHg; mean difference, -6.8 mmHg; 95% CI, -8.7 to -4.9 mmHg, respectively). Greater reductions in BP were observed with uRDN compared with sham for 24-hour ambulatory systolic BP (mean [SD], -7.9 [11.1] mmHg vs -3.1 [12.2] mmHg; mean difference, -5.3; 95% CI, -7.4 to -3.3 mmHg; P < .001), home systolic BP (mean [SD], -8.4 [11.0] mmHg vs -1.4 [9.4] mmHg; mean difference, -6.8; 95% CI, -8.7 to -4.9 mmHg; P < .001), and office systolic BP (mean [SD], -10.4 [15.0] mmHg vs -3.4 [16.7] mmHg; mean difference -6.4’ 95% CI, -9.1 to -3.6 mmHg; P < .001). No differences in early safety endpoints were observed between the uRDN and sham groups.
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