{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,27]],"date-time":"2026-10-27T23:58:57Z","timestamp":1793145537812,"version":"4.5.0"},"reference-count":40,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"10","funder":[{"DOI":"10.13039\/100015371","name":"ReCor Medical","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100015371","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circulation"],"published-print":{"date-parts":[[2024,3,5]]},"abstract":"<jats:sec>\n                    <jats:title>BACKGROUND:<\/jats:title>\n                    <jats:p>The randomized, sham-controlled RADIANCE-HTN (A Study of the Recor Medical Paradise System in Clinical Hypertension) SOLO, RADIANCE-HTN TRIO, and RADIANCE II (A Study of the Recor Medical Paradise System in Stage II Hypertension) trials independently met their primary end point of a greater reduction in daytime ambulatory systolic blood pressure (SBP) 2 months after ultrasound renal denervation (uRDN) in patients with hypertension. To characterize the longer-term effectiveness and safety of uRDN versus sham at 6 months, after the blinded addition of antihypertensive treatments (AHTs), we pooled individual patient data across these 3 similarly designed trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS:<\/jats:title>\n                    <jats:p>Patients with mild to moderate hypertension who were not on AHT or with hypertension resistant to a standardized combination triple AHT were randomized to uRDN (n=293) versus sham (n=213); they were to remain off of added AHT throughout 2 months of follow-up unless specified blood pressure (BP) criteria were exceeded. In each trial, if monthly home BP was \u2265135\/85 mm Hg from 2 to 5 months, standardized AHT was sequentially added to target home BP &lt;135\/85 mm Hg under blinding to initial treatment assignment. Six-month outcomes included baseline- and AHT-adjusted change in daytime ambulatory, home, and office SBP; change in AHT; and safety. Linear mixed regression models using all BP measurements and change in AHT from baseline through 6 months were used.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS:<\/jats:title>\n                    <jats:p>\n                      Patients (70% men) were 54.1\u00b19.3 years of age with a baseline daytime ambulatory\/home\/office SBP of 150.5\u00b19.8\/151.0\u00b112.4\/155.5\u00b114.4 mm Hg, respectively. From 2 to 6 months, BP decreased in both groups with AHT titration, but fewer uRDN patients were prescribed AHT (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      =0.004), and fewer additional AHT were prescribed to uRDN patients versus sham patients (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      =0.001). Whereas the unadjusted between-group difference in daytime ambulatory SBP was similar at 6 months, the baseline and medication-adjusted between-group difference at 6 months was \u22123.0 mm Hg (95% CI, \u22125.7, \u22120.2;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      =0.033), in favor of uRDN+AHT. For home and office SBP, the adjusted between-group differences in favor of uRDN+AHT over 6 months were \u22125.4 mm Hg (\u22126.8, \u22124.0;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt;0.001) and \u22125.2 mm Hg (\u22127.1, \u22123.3;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt;0.001), respectively. There was no heterogeneity between trials. Safety outcomes were few and did not differ between groups.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS:<\/jats:title>\n                    <jats:p>This individual patient-data analysis of 506 patients included in the RADIANCE trials demonstrates the maintenance of BP-lowering efficacy of uRDN versus sham at 6 months, with fewer added AHTs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>REGISTRATION:<\/jats:title>\n                    <jats:p>\n                      URL:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\">https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n                      ; Unique identifiers: NCT02649426 and NCT03614260.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1161\/circulationaha.123.066941","type":"journal-article","created":{"date-parts":[[2023,10,26]],"date-time":"2023-10-26T17:00:16Z","timestamp":1698339616000},"page":"747-759","update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":45,"title":["Patient-Level Pooled Analysis of Endovascular Ultrasound Renal Denervation or a Sham Procedure 6 Months After Medication Escalation: The RADIANCE Clinical Trial Program"],"prefix":"10.1161","volume":"149","clinical-trial-number":[{"clinical-trial-number":"nct02649426","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct03614260","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0597-8318","authenticated-orcid":true,"given":"Michel","family":"Azizi","sequence":"first","affiliation":[{"name":"Universit\u00e9 Paris Cit\u00e9, France (M.A.)."},{"name":"AP-HP, H\u00f4pital Europ\u00e9en Georges-Pompidou, Hypertension Department and DMU CARTE, Paris, France (M.A.)."},{"name":"INSERM, Paris, France (M.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9085-8881","authenticated-orcid":true,"given":"Andrew S.P.","family":"Sharp","sequence":"additional","affiliation":[{"name":"University Hospital of Wales and Cardiff University, Cardiff, UK (A.S.P.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1649-1441","authenticated-orcid":true,"given":"Naomi D.L.","family":"Fisher","sequence":"additional","affiliation":[{"name":"The Brigham and Women\u2019s Hospital, Boston, MA (N.D.L.F.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8504-0831","authenticated-orcid":true,"given":"Michael A.","family":"Weber","sequence":"additional","affiliation":[{"name":"Division of Cardiovascular Medicine, State University of New York, Downstate Medical Center, New York (M.A.W., M.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1122-948X","authenticated-orcid":true,"given":"Melvin D.","family":"Lobo","sequence":"additional","affiliation":[{"name":"Barts NIHR Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, UK (M.D.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8628-1410","authenticated-orcid":true,"given":"Joost","family":"Daemen","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Erasmus University Medical Center Rotterdam, the Netherlands (J.D.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5993-4487","authenticated-orcid":true,"given":"Philipp","family":"Lurz","sequence":"additional","affiliation":[{"name":"Zentrum f\u00fcr Kardiologie, Universit\u00e4tsmedizin Mainz, Germany (P.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4425-549X","authenticated-orcid":true,"given":"Felix","family":"Mahfoud","sequence":"additional","affiliation":[{"name":"Klinik f\u00fcr Innere Medizin III, Saarland University Hospital, Homburg\/Saar, Germany (F.M.)."},{"name":"Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge (F.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2356-5883","authenticated-orcid":true,"given":"Roland E.","family":"Schmieder","sequence":"additional","affiliation":[{"name":"Nephrology and Hypertension, University Hospital Erlangen, Friedrich Alexander University, Erlangen, Germany (R.E.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2302-7084","authenticated-orcid":true,"given":"Jan","family":"Basile","sequence":"additional","affiliation":[{"name":"Division of Cardiovascular Medicine, Medical University of South Carolina, Ralph H. 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