Kandzari DE, et al. - In this international, randomized, single-blind, sham-control, proof-of-concept trial, the researchers assessed safety and blood pressure response after renal denervation or sham control in subjects with uncontrolled hypertension on antihypertensive medications with drug adherence testing. Compared with sham control with no major safety events, renal denervation in the main renal arteries and branches significantly decreased blood pressure. It was noted that incomplete medication adherence was common.

Methods

• For this trial, patients with uncontrolled hypertension (aged 20–80 years) were recruited at 25 centers in the US, Germany, Japan, UK, Australia, Austria, and Greece.
• Eligibility criteria was an office systolic blood pressure between 150 mm Hg and 180 mm Hg and a diastolic blood pressure 90 mm Hg or higher, a 24-hour ambulatory systolic blood pressure between 140 mm Hg and 170 mm Hg at second screening, and were on one to three antihypertensive drugs with stable doses for at least 6 weeks.
• Participants underwent renal angiography and were randomly assigned to undergo renal denervation or sham control.
• Patients, caregivers, and those assessing blood pressure were masked to randomization assignments.
• Blood pressure change from baseline (measured at screening visit two) based on ambulatory blood pressure measurements assessed at 6 months as compared between treatment groups was the primary efficacy endpoint.
• They used drug surveillance to assess medication adherence.
• In the intention-to-treat population, the primary analysis was done.
• Finally, safety events were evaluated through 6 months.

Results

• Four hundred sixty-seven patients were screened and enrolled between July 22, 2015 and June 14, 2017.
• This investigation presented results for the first 80 patients assigned randomly to renal denervation (n=38) and sham control (n=42).
• Results showed that office and 24-hour ambulatory blood pressure was significantly reduced from baseline to 6 months in the renal denervation group (mean baseline-adjusted treatment differences in 24-hour systolic blood pressure -7.0 mm Hg, 95% CI -12.0 to -2.1; p=0.0059, 24 hour diastolic blood pressure -4.3 mm Hg, -7.8 to -0.8; p=0.0174, office systolic blood pressure -6.6 mm Hg, -12.4 to -0.9; p=0.0250, and office diastolic blood pressure -4·2 mm Hg, -7.7 to -0.7; p=0.0190).
• Findings revealed that the change in blood pressure was significantly greater at 6 months in the renal denervation group vs the sham-control group for office systolic blood pressure (difference -6.8 mm Hg, 95% CI -12.5 to -1.1; p=0.0205), 24-hour systolic blood pressure (difference -7.4 mm Hg, -12.5 to -2.3; p=0.0051), office diastolic blood pressure (difference -3.5 mm Hg, -7.0 to -0.0; p=0.0478), and 24-hour diastolic blood pressure (difference -4.1 mm Hg, -7.8 to -0.4; p=0.0292).
• It was noted that evaluation of hourly changes in 24-hour systolic blood pressure and diastolic blood pressure exhibited blood pressure reduction throughout 24 hours for the renal denervation group.
• It was found that 3-month blood pressure reductions were not significantly different between groups.
• Throughout the study, medication adherence was about 60% and varied for individual patients.
• Researchers did not find any major adverse events in either group.