Patients in the RADIANCE-HTN SOLO trial who crossed over from the sham-control arm and were treated with ultrasound-based renal denervation saw a similar lowering of blood pressure to patients who were assigned to the renal denervation arm, according to a post hoc analysis of the trial presented Friday at the PCR e-Course.
Hypertension is the leading cause of disease burden world-wide. Its control is a continues problem, with rates reaching a plateau. One major contributing factor is drug adherence.
Renal denervation is an endovascular therapy that does not require adherence and can be used along with medical therapy to gain hypertension control. The Paradise Renal Denervation System (ReCor Medical Inc.) delivers ultrasound energy (sound waves) via a catheter to the tissue surrounding the renal artery for several seconds. This energy generates heat to decrease the overactivity of the nerves leading to the kidney.
This system was shown to lower blood pressure in comparison with a sham control in patients with hypertension in the RADIANCE-HTN SOLO study, a multicenter, randomized control trial. Ajay J. Kirtane, MD, SM, of Columbia University Irving Medical Center/New York Presbyterian Hospital, presented an analysis of data from patients who had crossed over from the sham-control arm to the renal denervation arm after having persistently high blood pressure after 12 months of follow-up.
Their analysis demonstrated that of the 72 patients in the original sham-control group, 31 had crossed over to undergo renal denervation after 12 months of uncontrolled blood pressure. These crossover patients had a mean age of 54 years, 39% were women, 77% were white, 13% were Black, they had an average body mass index of 28.1 kg/m2 and estimated glomerular filtration rate of 80 mL/min/1.73 m2. At time of crossover, they had an average blood pressure 145/90 mmHg and were on average on 1.2 antihypertensive medications.
All of these patients had successful denervation, with no adverse events. Their post-denervation daytime ambulatory systolic blood pressure decreased by 11.2 mmHg at 2 months and and by 12.2 mmHg at 6 months. The percentage of patients who saw their daytime ambulatory systolic blood pressure drop by at least 5 mmHg – without increasing medications – was 71% at 2 months and 68% at 6 months.
Although crossover subjects and physicians were unblinded, making them possibly biased as far as both medication or behavioral effects, or both, the results of the study remained similar to those found in the original study, Kirtane said.
The RADIANCE-HTN SOLO trial was sponsored by ReCor Medical Inc.
The PCR e-Course is the virtual meeting being held in place of the annual in-person EuroPCR congress, which was canceled because of the COVID-19 pandemic.