Renal denervation lowers daytime BP without help of medications
Ultrasound renal denervation yields reductions in daytime ambulatory systolic blood pressure (BP) in the absence of BP-lowering medications and without major safety issues, according to a study.
The study included adult patients with hypertension (seated office systolic BP ≥140 mm Hg and diastolic BP ≥90 mm Hg despite being on two antihypertensive medications) and ambulatory systolic/diastolic BP of ≥135/85 mm Hg and a systolic/diastolic BP <170/105 mm Hg after a 4-week washout of their medications.
A total of 234 patients (mean age 55 years, 28.6 percent women, 16.1 percent Black or African American) with an estimated glomerular filtration rate (eGFR) of at least 40 mL/min/1.73 m2 and with suitable renal artery anatomy underwent treatment. They were randomly assigned to receive ultrasound renal denervation (n=150) or a sham procedure (n=74). All patients were required to pause their BP-lowering medications until the 2-month follow-up unless prespecified BP criteria were exceeded and were associated with clinical symptoms.
At 2 months, the primary efficacy outcome of the mean change in daytime ambulatory systolic BP was significantly greater in the ultrasound renal denervation arm than in the sham procedure arm (−7.9 vs −1.8 mm Hg; baseline-adjusted between-group difference, −6.3 mm Hg, 95 percent confidence interval [CI], −9.3 to −3.2; p<0.001).
Moreover, the favourable effect of ultrasound renal denervation was consistently observed throughout the 24-hour circadian cycle.
Changes in six of the seven prespecified secondary BP outcomes (24-hour ambulatory systolic and diastolic BP, home systolic and diastolic BP, office systolic and diastolic BP, and daytime ambulatory diastolic BP) were significantly better with ultrasound renal denervation than with the sham procedure.
None of the patients in either group experienced any major adverse events.