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Effect of Ultrasound-Based Renal Denervation at 6 Months
Quick Takes
- 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%).
Study Questions:
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?
Methods:
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.
Results:
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.
Conclusions:
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.
Perspective:
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.
Clinical Topics: Noninvasive Imaging, Prevention, Echocardiography/Ultrasound, Hypertension
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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