36-month durability of ultrasound renal denervation for hypertension resistant to combination therapy in RADIANCE-HTN TRIO
Michael J. Bloch, Ajay J. Kirtane, Michel Azizi, Felix Mahfoud, Jan Basile, Joost Daemen, Manish Saxena, Lisa Thackeray, Maureen McGuire, Lisa Claude, Roland E. Schmieder, On behalf of the RADIANCE-HTN Investigators, Yale Wang, Nedaa Skeik, Richard Bae, Amy McMeans, JoAnne Goldman, Rose Peterson, James Stephen Jenkins, Isabelle Tutor, Michael Harrison, Angel Penning, Chandan Devireddy, Janice Lea, Amanda Fiebach, Claudia Merlin, Florian Rader, Suhail Dohad, Anne Tran, Kirin Bhatia, Naomi D. L. Fisher, Piotr Sobieszczyk, Ian Halliday, Tay Munson, Jason Lindsey, Steven Laster, Mathew Bunte, Anthony Hart, Dana King, Jamie Hall, Kintur Sanghvi, Courtney Krathen, Luot Lewis, Ashley Willitts, Thomas Todoran, Jan Basile, Anthony Awkar, Casey Palmer, Anna Tecklenburg, John Schindler, John Pacella, Matthew Muldoon, MaryJo Albright, Tracy Nicholson, John Flack, Youseff Chami, Abdul Moiz Hafiz, Emily Starkey, Kristal Adams, Nelson Bernardo, Judith Veis, Hayder Hashim, Suman Singh, Donna Whitman, Rick Stouffer, Alan Hinderliter, Meghan Allen, Tatum Scholl, Pete Fong, James Gainer, Sherron Crook, Ellen Hatchcock, Debbie Cohen, Jay Giri, Taisei Kobayashi, Robin Neubauer, Suveeksha Naidu, Ajay J. Kirtane, Jai Radhakrishnan, Candido Batres, Suzanne Edwards, Matheen Khuddus, Suzanne Zentko, Abby Touchton, Marti Roberson, Michael J. Bloch, Abhilash Akinapelli, Lisa English, Bridget Neumann, Farrel Mendelsohn, Hutton Brantley, Thomas Cawthon, Susan DeRamus, Wesley Wade, Robert Fishman, Edward Tuohy, Jessica LeBlanc, Tina McCurry, Amar Krishnaswamy, Luke Laffin
Abstract
Endovascular ultrasound renal denervation (uRDN) reduced blood pressure (BP) compared to sham at 2 months in patients with resistant hypertension in the multicenter, blinded, randomized, sham-controlled RADIANCE-HTN TRIO trial. This analysis evaluates longer-term outcomes of patients randomized to uRDN. Patients with resistant hypertension to a 3-drug combination pill were randomized to uRDN (n = 69) or sham (n = 67). From 2-5 months, patients followed a standardized anti-hypertensive medication (AHM) titration protocol. At 6 months, patients were unblinded and received AHM per standard of care. In the uRDN group, 71% (49/69) completed 36-month follow-up. Screening office BP was 159/103 on 3.9 AHM. Baseline office BP on the single-pill combination was 153/99 mmHg. At 36 months, office BP changed by -14.5 ± 26.1/-9.0 ± 14.8 mmHg from screening (p < 0.001 for both) and -8.0 ± 24.5/-5.0 ± 14.6 mmHg from baseline (p = 0.007; p = 0.022) on 3.7 AHM. The efficacy of uRDN was durable to 36 months in patients with resistant hypertension with no safety concerns.