TCT-588 24-Month Durability of the Blood Pressure Lowering Effect of Ultrasound Renal Denervation for Hypertension with the Paradise System

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Authors

Azizi M.
Sharp A.
Fisher N.
Daemen J.
Lurz P.
Mahfoud F.
Schmieder R.
Bloch M.
Saxena M.
Wang Y.

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2025

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Background: Ultrasound renal denervation (uRDN) was shown to lower blood pressure (BP) across the spectrum of uncontrolled hypertension (HTN) at 2 and 6 months within the three multicenter, blinded, randomized, sham-controlled trials of the RADIANCE program. Method(s): We report the 24-month BP results of uRDN following unblinding of patients, pooling individual patient data across the 3 trials. 24-month outcomes included change in office systolic BP (SBP); change in anti-hypertensive medications (AHM); and safety. Linear mixed regression models using all BP measurements and change in AHM from baseline through 24 months were used. Result(s): At 24 months, 83% (243/293) of uRDN patients had follow-up SBP measurements. Among these patients, mean age was 54.4+/-9.8 years, and baseline BP was 155.6+/-13.9 mmHg. The adjusted change in SBP was -9.8, -17.1, -15.5, and -15.9 mmHg at 2, 6, 12, and 24 months respectively, with minimal change in AHMs (Fig. 1). Among uRDN patients, 77.4%, 67.1% and 47.3% had SBP decreases of >= 5, >= 10 and >= 20 mmHg, respectively. The proportion of patients reaching SBP target of < 130 and < 140 mmHg was 32.5% and 54.3% at 24 months. There were no clinical safety events from 6 to 24 months. [Formula presented] Conclusion(s): Ultrasound renal denervation demonstrated sustained BP reduction over 24 months in patients with uncontrolled HTN, with no long-term safety concerns. Categories: ENDOVASCULAR: Hypertension Therapies and Renal Denervation Copyright © 2025

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Journal of the American College of Cardiology

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15

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