Patients who crossed over from the sham control arm of the RADIANCE-HTN SOLO trial to the renal denervation arm after 12 months of elevated blood pressure had decreased daytime ambulatory systolic blood pressure at both two and six months following renal denervation. The analysis of the crossover cohort was presented by Ajay J Kirtane (Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, USA) during a late-breaking trial session at the PCR e-Course 2020 (25–27 June).
RADIANCE-HTN SOLO was a multicentre randomised controlled trial that demonstrated the blood pressure lowering effect of endovascular ultrasound based renal denervation (Paradise, ReCor Medical) compared with a sham control. Patients randomised to sham treatment who had daytime systolic ambulatory blood pressure ≥135mmHg or daytime diastolic ambulatory blood pressure ≥85mmHg after 12 months of follow-up were permitted to crossover to receive endovascular ultrasound based renal denervation.
Kirtane explained: “This analysis represents data on the cohort of 31 patients that had crossed-over as of January 2020. Complete two-month ambulatory blood pressure data are available on 31 participants, with complete six-month data available on 25 patients.”
Average age in the crossover population was 54 years, and 39% were female. Average daytime ambulatory blood pressure was 145/90mmHg, with a 24-hour ABP of 138/85mmHg, and office blood pressure of 146/95mmHg. The average number of hypertensive medications at crossover was 1.2±0.7, and the mean time from randomisation to crossover was 23±5 months.
There was 100% procedural success with renal denervation and there were no deaths from any cause.
Kirtane said: “This cohort demonstrated a daytime ambulatory systolic blood pressure change of -11.2mmHg at two months and -12.2mmHg at six months [p<0.001 in comparison to 12-month baseline for both], without an increase in medication burden; through six months, there were no major adverse events following crossover.”
At two months, 71% of patients had a decrease of ≥5mmHg in daytime ambulatory systolic blood pressure; at six months, this was 68%. Among these patients with a response 5mmHg in daytime ambulatory systolic blood pressure, At two and six months, the average daily ambulatory systolic blood pressure reduction was 17.7 and 20.6mmHg, respectively.
Summing up, Kirtane told the online audience: “Control of hypertension represents an unmet need globally, and renal denervation is an ‘adherence-independent’ adjunctive therapy to medications. These results are consistent with the primary SOLO results; however, there was no drug titration protocol between two to six months for crossover patients, so this may provide some added insight into six-month durability after renal denervation.”
He additionally stressed that, because crossover subjects and physicians were unblinded, the data are subject to behavioural and/or medication-related effects and as such these results need to be interpreted first and foremost within the context of the blinded study results. Nonetheless, “these data are further supportive of an adjunctive role of ultrasound-based renal denervation in the treatment of hypertension, especially when considering how many patients with hypertension worldwide are currently uncontrolled”, Kirtane said.