Effect of Ultrasound-Based Renal Denervation at 6 Months
- Among patients with resistant hypertension who were randomly assigned to ultrasound renal denervation (uRDN) or a sham procedure and who had persistent elevation of BP at 2 months after the procedure, uRDN was associated with similar BP reductions and use of fewer medications.
- Fewer medications were added in the uRDN group (0.7 vs. 1) and fewer patients in the uRDN group received aldosterone antagonists at 6 months (40% vs. 61%).
What are the blood pressure (BP) effects and how safe is ultrasound renal denervation (uRDN) versus sham at 6 months in conjunction with escalating antihypertensive medications?
This randomized, sham-controlled, clinical trial with outcome assessors and patients blinded to treatment assignment, enrolled patients from March 11, 2016, to March 13, 2020. Participants with daytime ambulatory BP of 135/85 mm Hg or higher after 4 weeks of single-pill triple-combination treatment (angiotensin-receptor blocker, calcium channel blocker, and thiazide diuretic) with estimated glomerular filtration rate (eGFR) of ≥40 mL/min/1.73 m2 were randomly assigned to uRDN or sham with medications unchanged through 2 months. From 2 to 5 months, if monthly home BP was 135/85 mm Hg or higher, standardized stepped-care antihypertensive treatment starting with aldosterone antagonists was initiated under blinding to treatment assignment. The study endpoint included 6-month change in medications, change in daytime ambulatory systolic BP, change in home systolic BP adjusted for baseline BP, and medications and safety.
A total of 65 of 69 participants in the uRDN group and 64 of 67 participants in the sham group (mean [SD] age, 52.4 [8.3] years; 104 male [80.6%]) with a mean (SD) eGFR of 81.5 (22.8) mL/min/1.73 m2 had 6-month daytime ambulatory BP measurements. Fewer medications were added in the uRDN group (mean [SD], 0.7 [1.0] medications) versus sham (mean [SD], 1.1 [1.1] medications; p = 0.045) and fewer patients in the uRDN group received aldosterone antagonists at 6 months (26 of 65 [40.0%] vs. 39 of 64 [60.9%]; p = 0.02). Despite less intensive standardized stepped-care antihypertensive treatment, mean (SD) daytime ambulatory BP at 6 months was 138.3 (15.1) mm Hg with uRDN versus 139.0 (14.3) mm Hg with sham (additional decreases of −2.4 [16.6] vs. −7.0 [16.7] mm Hg from month 2, respectively), whereas home systolic BP was lowered to a greater extent with uRDN by 4.3 mm Hg (95% confidence interval [CI], 0.5-8.1 mm Hg; p = 0.03) in a mixed model adjusting for baseline and number of medications. Adverse events were infrequent and similar between groups.
In this study, in patients with resistant hypertension initially randomly assigned to uRDN or a sham procedure and who had persistent elevation of BP at 2 months after the procedure, standardized stepped-care antihypertensive treatment escalation resulted in similar BP reduction in both groups at 6 months, with fewer additional medications required in the uRDN group.
This was a prespecified 6-month analysis from the randomized, sham-controlled clinical trial of ultrasound-based renal denervation in patients with resistant hypertension. Findings from this small, predominantly male study show that among patients with resistant hypertension who were randomly assigned to uRDN or a sham procedure and who had persistent elevation of BP at 2 months after the procedure, uRDN was associated with similar BP reductions and use of fewer medications. The long-term effects of catheter-based denervation and its role in clinical practice remains to be determined.
Keywords: Angiotensins, Antihypertensive Agents, Blood Pressure, Blood Pressure Monitoring, Ambulatory, Calcium Channel Blockers, Catheters, Denervation, Diuretics, Glomerular Filtration Rate, Hypertension, Mineralocorticoid Receptor Antagonists, Primary Prevention, Sodium Chloride Symporter Inhibitors, Sympathectomy, Ultrasonography, Interventional
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