A Three-Arm Randomized Trial of Different Renal Denervation Devices and Techniques in Patients With Resistant Hypertension (RADIOSOUND-HTN)
| Autor: | Holger Thiele, Maximilian von Roeder, Steffen Desch, Karl-Philipp Rommel, Sindy Winkler, Philipp Lurz, Robert Höllriegel, Martin Petzold, Philipp Hartung, Stephan Blazek, Karl Fengler, Christian Besler |
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| Rok vydání: | 2018 |
| Předmět: |
Male
Sympathetic nervous system medicine.medical_specialty Time Factors Resistant hypertension Urology Drug Resistance Blood Pressure 030204 cardiovascular system & hematology Kidney law.invention 03 medical and health sciences 0302 clinical medicine Renal Artery Randomized controlled trial law Ultrasonic Surgical Procedures Physiology (medical) Medicine Humans In patient Single-Blind Method 030212 general & internal medicine Sympathectomy Antihypertensive Agents Aged Denervation business.industry Ultrasound Middle Aged medicine.anatomical_structure Treatment Outcome Renal sympathetic denervation Hypertension Catheter Ablation Female Cardiology and Cardiovascular Medicine business |
| Zdroj: | Circulation. 139(5) |
| ISSN: | 1524-4539 0292-0034 |
| Popis: | Background: Both radiofrequency and ultrasound endovascular renal sympathetic denervation (RDN) have proven clinical efficacy for the treatment of hypertension. We performed a head-to-head comparison of these technologies. Methods: Patients with resistant hypertension were randomly assigned in a 1:1:1 manner to receive either treatment with (1) radiofrequency RDN of the main renal arteries; (2) radiofrequency RDN of the main renal arteries, side branches, and accessories; or (3) an endovascular ultrasound–based RDN of the main renal artery. The primary end point was change in systolic daytime ambulatory blood pressure at 3 months. Results: Between June 2015 and June 2018, 120 patients were enrolled (mean age, 64±9 years±SD; mean daytime blood pressure, 153/86±12/13 mm Hg). Of these, 39 were randomly assigned to radiofrequency main renal artery ablation, 39 to combined radiofrequency ablation of the main artery and branches, and 42 to ultrasound-based treatment. Baseline daytime blood pressure, clinical characteristics, and treatment were well balanced between the groups. At 3 months, systolic daytime ambulatory blood pressure decreased by 9.5±12.3 mm Hg ( P P =0.038 by ANOVA, adjusted P =0.043), no significant difference was found between the radiofrequency ablation groups (–8.3±11.7 mm Hg for additional side branch ablation; mean difference, –1.8 mm Hg; adjusted P >0.99). Similarly, the blood pressure reduction was not found to be significantly different between the ultrasound and the side branch ablation groups. Frequencies of blood pressure response ≥5 mm Hg were not significantly different (global P =0.77). Conclusions: In patients with resistant hypertension, endovascular ultrasound–based RDN was found to be superior to radiofrequency ablation of the main renal arteries only, whereas a combined approach of radiofrequency ablation of the main arteries, accessories, and side branches was not. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02920034. |
| Databáze: | OpenAIRE |
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