Delhi: With fewer prescribed antihypertensive medications, the BP lowering effect of endovascular ultrasound renal denervation (RDN) was maintained at 12 months compared to sham, according to a recent study in the journal JACC: Cardiovascular Interventions.
Previous RCTs have shown the blood pressure (BP)–lowering efficacy and safety of endovascular ultrasound renal denervation in the absence and presence of antihypertensive medications. This study by Michel Azizi , Hypertension Department and DMU Carte, Paris, France, and colleagues reports the 12-month results of the RADIANCE-HTN (A Study of the ReCor Medical Paradise System in Clinical Hypertension) SOLO trial following unblinding of patients at 6 months.
It included patients with daytime ambulatory BP ≥135/85 mm Hg after 4 weeks off medication. They were randomized to receive RDN (n = 74) or sham (n = 72) and maintained off medication for 2 months. A standardized medication escalation protocol was instituted between 2 and 5 months (blinded phase). Between 6 and 12 months (unblinded phase), patients received antihypertensive medications at physicians' discretion.
Outcomes at 12 months included medication burden, change in daytime ambulatory systolic BP (dASBP) and office or home systolic BP (SBP), visit-to-visit variability in SBP, and safety.
Key findings of the study include:
Sixty-five of 74 RDN patients and 67 of 72 sham patients had 12-month dASBP measurements.
The proportion of patients on ≥2 medications (27.7% vs. 44.8%), the number of medications (0 vs. 1.4), and defined daily dose (1.4 vs. 2.2) were less with RDN versus sham.
The decrease in dASBP from baseline in the RDN group (−16.5 ± 12.9 mm Hg) remained stable at 12 months.
The RDN versus sham adjusted difference at 12 months was −2.3 mm Hg for dASBP, −6.3 mm Hg for office SBP, and −3.4 mm Hg for home SBP.
Visit-to-visit variability in SBP was smaller in the RDN group.
No renal artery injury was detected on computed tomographic or magnetic resonance angiography.
"The decrease in BP with a treatment strategy including RDN followed by subsequent addition of antihypertensive medications was associated with a lower VVV of BP than a treatment strategy including stepped-care intensified antihypertensive treatment only," wrote the authors.
"Despite unblinding, the BP-lowering effect of RDN was maintained at 12 months with fewer prescribed medications compared with sham." they concluded.