Charles Sternberg, Associate Editor05.17.22
At the EuroPCR annual meeting in Paris, Dr. Ajay Kirtane presented a pooled data analysis from ReCor’s two randomized, sham-controlled trials evaluating the Paradise Ultrasound Renal Denervation (uRDN) System for the treatment of hypertension.
The analysis demonstrated a statistically significant reduction in blood pressure (BP) across a broad range of hypertension severity as represented in the RADIANCE-HTN SOLO and TRIO studies. The data was presented in a late-breaking session titled “Hypertension management in 2022: control it, live longer” on World Hypertension Day.
There were consistent benefits in both blood pressure reduction and medication burden across the pooled patient population compared to sham. The combined dataset showed an overall between-group difference through 6 months favoring uRDN in daytime ambulatory systolic BP of -4.8 mmHg (95% CI: -7.1 to -2.5, p<0.001) and home systolic BP of -5.4 mmHg (95% CI: -7.3 to -3.6, p<0.001).
“The results of this pooled analysis make clear the consistent blood pressure-lowering effect that ultrasound renal denervation can have across differing severities of hypertension, regardless of trial design and whether the enrolled patients are on or off antihypertensive medications,” said principal investigator Ajay Kirtane, professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons and NewYork-Presbyterian Hospital. “Assuming continued safety of the procedure is demonstrated, ultrasound renal denervation is a promising treatment option complementary to lifestyle modification and medications for patients with uncontrolled hypertension.”
The RADIANCE Global Program is an international, multicenter, first-of-its-kind initiative designed to explore the benefits of ultrasound renal denervation (uRDN) in hypertension. The RADIANCE studies are double-blind, randomized, sham-controlled trials designed to provide additional information about the ability of the Paradise uRDN System to treat high blood pressure. RADIANCE-HTN includes the aforementioned SOLO and TRIO studies, which were individually powered for efficacy with a primary endpoint of daytime systolic ambulatory blood pressure (ABP) at two months. Both studies met their primary efficacy and safety endpoints at two months.
The RADIANCE Global Program also includes RADIANCE-II, a pivotal trial which recently completed patient enrollment. Study outcomes will be presented to the scientific and medical communities later this year. Results will report on the safety and effectiveness of the Paradise uRDN System to reduce blood pressure in patients with hypertension, in the absence of antihypertensive medications.
The Paradise uRDN System bears the CE mark for the treatment of hypertension in Europe and is an investigational device in the United States. Hypertension is the leading contributor to disease burden worldwide, leading to increased cardiovascular morbidity and mortality, poorer quality of life, and increased cost to health systems.
The analysis demonstrated a statistically significant reduction in blood pressure (BP) across a broad range of hypertension severity as represented in the RADIANCE-HTN SOLO and TRIO studies. The data was presented in a late-breaking session titled “Hypertension management in 2022: control it, live longer” on World Hypertension Day.
About the Analysis
The pooled analysis combined data from 282 patients randomized in ReCor’s two prospectively powered, sham-controlled studies enrolling two disparate patient populations: TRIO (patients with resistant hypertension) and SOLO (patients with mild-moderate hypertension).There were consistent benefits in both blood pressure reduction and medication burden across the pooled patient population compared to sham. The combined dataset showed an overall between-group difference through 6 months favoring uRDN in daytime ambulatory systolic BP of -4.8 mmHg (95% CI: -7.1 to -2.5, p<0.001) and home systolic BP of -5.4 mmHg (95% CI: -7.3 to -3.6, p<0.001).
“The results of this pooled analysis make clear the consistent blood pressure-lowering effect that ultrasound renal denervation can have across differing severities of hypertension, regardless of trial design and whether the enrolled patients are on or off antihypertensive medications,” said principal investigator Ajay Kirtane, professor of Medicine at Columbia University, Vagelos College of Physicians and Surgeons and NewYork-Presbyterian Hospital. “Assuming continued safety of the procedure is demonstrated, ultrasound renal denervation is a promising treatment option complementary to lifestyle modification and medications for patients with uncontrolled hypertension.”
The RADIANCE Global Program is an international, multicenter, first-of-its-kind initiative designed to explore the benefits of ultrasound renal denervation (uRDN) in hypertension. The RADIANCE studies are double-blind, randomized, sham-controlled trials designed to provide additional information about the ability of the Paradise uRDN System to treat high blood pressure. RADIANCE-HTN includes the aforementioned SOLO and TRIO studies, which were individually powered for efficacy with a primary endpoint of daytime systolic ambulatory blood pressure (ABP) at two months. Both studies met their primary efficacy and safety endpoints at two months.
The RADIANCE Global Program also includes RADIANCE-II, a pivotal trial which recently completed patient enrollment. Study outcomes will be presented to the scientific and medical communities later this year. Results will report on the safety and effectiveness of the Paradise uRDN System to reduce blood pressure in patients with hypertension, in the absence of antihypertensive medications.
The Paradise uRDN System bears the CE mark for the treatment of hypertension in Europe and is an investigational device in the United States. Hypertension is the leading contributor to disease burden worldwide, leading to increased cardiovascular morbidity and mortality, poorer quality of life, and increased cost to health systems.