학술논문
Six-Month Results of Treatment-Blinded Medication Titration for Hypertension Control After Randomization to Endovascular Ultrasound Renal Denervation or a Sham Procedure in the RADIANCE-HTN SOLO Trial
Document Type
Academic Journal
Author
Azizi, Michel; Schmieder, Roland E.; Mahfoud, Felix; Weber, Michael A.; Daemen, Joost; Lobo, Melvin D.; Sharp, Andrew S.P.; Bloch, Michael J.; Basile, Jan; Wang, Yale; Saxena, Manish; Lurz, Philipp; Rader, Florian; Sayer, Jeremy; Fisher, Naomi D.L.; Fouassier, David; Barman, Neil C.; Reeve-Stoffer, Helen; McClure, Candace; Kirtane, Ajay J.; Jay, Desmond; Skeik, Nedaa; Schwartz, Robert; Dohad, Suhail; Victor, Ronald; Sanghvi, Kintur; Costello, Josh; Walsh, Courtney; Abraham, Josephine; Owan, Theophilus; Abraham, Anu; Mauri, Laura; Sobieszczky, Piotr; Williams, Jonathan; Roongsritong, Chanwit; Todoran, Thomas; Powers, Eric; Hodskins, Emily; Fong, Pete; Laffer, Cheryl; Gainer, James; Robbins, Mark; Reilly, John; Cash, Michael; Goldman, Jessie; Aggarwal, Sandeep; Ledley, Gary; His, David; Martin, Scott; Portnay, Edward; Calhoun, David; McElderry, Thomas; Maddox, William; Oparil, Suzanne; Huang, Pei-Hsiu; Jose, Powell; Khuddus, Matheen; Zentko, Suzanne; O’Meara, James; Barb, Ilie; Garasic, Joseph; Drachman, Doug; Zusman, Randy; Rosenfield, Kenneth; Devireddy, Chandan; Lea, Janice; Wells, Bryan; Stouffer, Rick; Hinderliter, Alan; Pauley, Eric; Potluri, Srinivasa; Biedermann, Scott; Bangalore, Sripal; Williams, Stephen; Zidar, David; Shishehbor, Mehdi; Effron, Barry; Costa, Marco; Radhakrishnan, Jai; Mathur, Anthony; Jain, Ajay; Iyer, Sudha Ganesh; Robinson, Nicholas; Edroos, Sadat Ali; Levy, Terry; Patel, Amit; Beckett, David; Bent, Clare; Davies, Justin; Chapman, Neil; Shin, Matthew Shun; Howard, James; Joseph, Anil; D’Souza, Richard; Gerber, Robert; Faris, Mohamad; Marshall, Andrew John; Elorz, Cristina; Höllriegel, Robert; Fengler, Karl; Rommel, Karl-Philipp; Böhm, Michael; Ewen, Sebastian; Lucic, Jelena; Ott, Christian; Schmid, Axel; Uder, Michael; Rump, Christian; Stegbauer, Johannes; Kröpil, Patric; Sapoval, Marc; Cornu, Erika; Lorthioir, Aurélien; Gosse, Philippe; Cremer, Antoine; Trillaud, Hervé; Papadopoulos, Panteleimon; Pathak, Atul; Honton, Benjamin; Lantelme, Pierre; Berge, Constance; Courand, Pierre-Yves; Feyz, Lida; Blankestijn, Peter; Voskuil, Michiel; Rittersma, Zwaantina; Kroon, A.A.; van Zwam, W.H.; Persu, Alexandre; Renkin, Jean
Source
Circulation. May 28, 2019 139(22):2542-2553
Subject
Language
English
ISSN
0009-7322
Abstract
BACKGROUND:: The multicenter, international, randomized, blinded, sham-controlled RADIANCE-HTN SOLO trial (A Study of the ReCor Medical Paradise System in Clinical Hypertension) demonstrated a 6.3 mm Hg greater reduction in daytime ambulatory systolic blood pressure (BP) at 2 months by endovascular ultrasound renal denervation (RDN) compared with a sham procedure among patients not treated with antihypertensive medications. We report 6-month results after the addition of a recommended standardized stepped-care antihypertensive treatment to the randomized endovascular procedure under continued blinding to initial treatment. METHODS:: Patients with a daytime ambulatory BP ≥135/85 mm Hg and <170/105 mm Hg after a 4-week discontinuation of up to 2 antihypertensive medications, and a suitable renal artery anatomy, were randomized to RDN (n=74) or sham (n=72). Patients were to remain off antihypertensive medications throughout the first 2 months of follow-up unless safety BP criteria were exceeded. Between 2 and 5 months, if monthly measured home BP was ≥135/85 mm Hg, a standardized stepped-care antihypertensive treatment was recommended consisting of the sequential addition of amlodipine (5 mg/d), a standard dose of an angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, and hydrochlorothiazide (12.5 mg/d), followed by the sequential uptitration of hydrochlorothiazide (25 mg/d) and amlodipine (10 mg/d). Outcomes included the 6-month (1) change in daytime ambulatory systolic BP adjusted for medications and baseline systolic BP, (2) medication burden, and (3) safety. RESULTS:: A total of 69/74 RDN patients and 71/72 sham patients completed the 6-month ambulatory BP measurement. At 6 months, 65.2% of patients in the RDN group were treated with the standardized stepped-care antihypertensive treatment versus 84.5% in the sham group (P=0.008), and the average number of antihypertensive medications and defined daily dose were less in the RDN group than in the sham group (0.9±0.9 versus 1.3±0.9, P=0.010 and 1.4±1.5 versus 2.0±1.8, P=0.018; respectively). Despite less intensive standardized stepped-care antihypertensive treatment, RDN reduced daytime ambulatory systolic BP to a greater extent than sham (−18.1±12.2 versus −15.6±13.2 mm Hg, respectively; difference adjusted for baseline BP and number of medications: −4.3 mm Hg, 95% confidence interval, −7.9 to −0.6, P=0.024). There were no major adverse events in either group through 6 months. CONCLUSIONS:: The BP-lowering effect of endovascular ultrasound RDN was maintained at 6 months with less prescribed antihypertensive medications compared with a sham control. CLINICAL TRIAL REGISTRATION:: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02649426.