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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,
  • 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,
  • Christopher Bajzer,
  • Marilyn Boros,
  • Monica Branche,
  • Josephine Abraham,
  • Anu Abraham,
  • Inge Stijleman,
  • David Hsi,
  • Scott Martin,
  • Edward Portnay,
  • Maryann Fiebach,
  • Carolina Garavito,
  • Todd Adams,
  • Andrew Teklinski,
  • Adam Leech,
  • Patrick Drilling,
  • Lynda Tulik,
  • Keith Benzuly,
  • James Paparello,
  • Dan Fintel,
  • Haydee Ramirez,
  • Lauren Kats,
  • Paul Huang,
  • Santanu Biswas,
  • Serena Risher,
  • Kristina Pratt,
  • Uzoma Ibebuogu,
  • Karen Johnson,
  • William Cushman,
  • Lisa Jones,
  • Leigh Jackson,
  • David Landers,
  • Tilak Pasala,
  • Thomas Salazer,
  • Peter Canino,
  • Patricia Arakelian,
  • Yi-Ming Yang,
  • Asma Khaliq,
  • Mitchell Weinberg,
  • Yihenew Abetu,
  • Alana Gulliver,
  • J. P. Reilly,
  • Joseph Garasic,
  • Atul Chugh,
  • Barry Bertolet,
  • Brian Go,
  • Raghava Gallapudi,
  • Joel Cohn,
  • Kevin Rogers,
  • Manish Saxena,
  • Anthony Mathur,
  • Ajay Jain,
  • Armida Balawon,
  • Oliver Zongo,
  • Christine Topham,
  • Andrew Sharp,
  • Richard Anderson,
  • Elizabeth Thompson,
  • Nikki Spiro,
  • Elizabeth Hodges,
  • Jaqueline Holder,
  • Timothy Ellam,
  • Alan Bagnall,
  • Ralph Jackson,
  • Victoria Bridgett,
  • Peter Wilson,
  • Neelanjan Das,
  • Timothy Doulton,
  • David Loader,
  • Gemma Hector,
  • Terry Levy,
  • Clare Bent,
  • Vivek Kodoth,
  • Stephanie Horler,
  • Sara Nix,
  • Nicholas Robinson,
  • Firas Al-Janabi,
  • Jeremy Sayer,
  • Sudha Ganesh Iyer,
  • Emily Redman,
  • Jonaifah Ramirez,
  • Sandosh Padmanabhan,
  • Faisal Sharif,
  • Aishah Alhmoudi,
  • Mattia Lunardi,
  • Eileen Coen,
  • Nicola Glynn,
  • Felix Mahfoud,
  • Lucas Lauder,
  • Saarraaken Kulenthiran,
  • Christina Koch,
  • Angelika Wachter,
  • Roland Schmieder,
  • Axel Schmid,
  • Dennis Kannenkeril,
  • Ulrike Heinritz,
  • Kerstin Endres-Frohlich,
  • Philipp Lurz,
  • Karl Rommel,
  • Karl Fengler,
  • Martin Petzold,
  • Margit Büttner,
  • Joachim Weil,
  • Tolga Agdirlioglu,
  • Tanja Köllner,
  • Jeannine Stephan,
  • Nikolaos Dagkonakis,
  • Frank Hamann,
  • Ute Ettl,
  • Ulrike Petzsche,
  • Peter Reimer,
  • Martin Hausberg,
  • Ralf Hinrichs,
  • Isabella Di Ponio-Voit,
  • Matthias Lutz,
  • Philippe Gosse,
  • Antoine Cremer,
  • Panteleimon Papadopoulos,
  • Julie Gaudissard,
  • Florent Maire,
  • Michel Azizi,
  • Marc Sapoval,
  • Marine Livrozet,
  • Asma Regrag,
  • Valerie Paquet,
  • Pascal Delsart,
  • Justin Hennicaux,
  • Coralie Sommeville,
  • Fabien Bertrand,
  • Joost Daemen,
  • Melvin Lafeber,
  • Victor Zeijen,
  • Amo Ruiter,
  • Elisabeth Huijskens,
  • Jan van Ramshorst,
  • Panagiotis Xaplanteris,
  • Rachid Briki,
  • Quentin de Hemptinne,
  • Severine Pascal,
  • Katty Renard,
  • Pascal Lefebvre,
  • Bert Ferdinande,
  • Juan F. Iglesias,
  • Georg Ehert,
  • Laetitia Gallego,
  • Kevin Dobretz,
  • Sylviane Bottone,
  • Josh Costello,
  • Courtney Krathan,
  • Andrew McElvarr,
  • John Reilly,
  • Stephen Jenkins,
  • Michael Cash,
  • Shannon Williams,
  • Maria Jarvis,
  • Cheryl Laffer,
  • Mark Robbins,
  • Sarita Maddel,
  • Maryanne Ducey,
  • Suzanne Rose,
  • Elizabeth DelMastro,
  • Sripal Bangalore,
  • Stephen Williams,
  • Stanley Cabos,
  • Carolina Rodriguez Alvarez,
  • Eric Powers,
  • Emily Hodskins,
  • Vijay Paladugu,
  • Bryan Wells,
  • Hyun-Min Kim,
  • Mohammad Rashid,
  • Theophilus Owan,
  • Iran Lavasani,
  • Hailey Neilson,
  • David Calhoun,
  • Thomas McElderry,
  • William Maddox,
  • Suzanne Oparil,
  • Sheila Kinder,
  • Joseph Garasic,
  • Doug Drachman,
  • Randy Zusman,
  • Kenneth Rosenfield,
  • Danny Do,
  • James O’Meara,
  • Ilie Barb,
  • Abby Foster,
  • Alice Boyette,
  • Desmond Jay,
  • Robert Schwartz,
  • Jo Anne Goldman,
  • Jessie Goldman,
  • Gary Ledley,
  • Nancy Katof,
  • Srinivasa Potluri,
  • Scott Biedermann Jacquelyn Ward,
  • Megan White,
  • Laura Mauri,
  • Piotr Sobieszczky,
  • Alex Smith,
  • Laura Aseltine,
  • Eric Pauley,
  • Tyrone Wade,
  • David Zidar,
  • Mehdi Shishehbor,
  • Barry Effron,
  • Marco Costa,
  • Terence Semenec,
  • Chanwit Roongsritong,
  • Priscilla Nelson,
  • Debbie Cohen,
  • Jay Giri,
  • Robin Neubauer,
  • Thu Vo,
  • Atul R. Chugh,
  • Pei-Hsiu Huang,
  • Powell Jose,
  • Michael Jones,
  • Manish Saxena,
  • Melvin D. Lobo,
  • Anthony Mathur,
  • Ajay Jain,
  • Armida Balawon,
  • Olivier Zongo,
  • Terry Levy,
  • Clare Bent,
  • David Beckett,
  • Nicki Lakeman,
  • Sarah Kennard,
  • Andrew Sharp,
  • Richard J. D’Souza,
  • Sarah Statton,
  • Lindsay Wilkes,
  • Christine Anning,
  • Jeremy Sayer,
  • Sudha Ganesh Iyer,
  • Nicholas Robinson,
  • Annaliza Sevillano,
  • Madelaine Ocampo,
  • Robert Gerber,
  • Mohamad Faris,
  • Andrew John Marshall,
  • Janet Sinclair,
  • Hayley Pepper,
  • Justin Davies,
  • Neil Chapman,
  • Paula Burak,
  • Paula Carvelli,
  • Sachin Jadhav,
  • Jane Quinn,
  • Lars Christian Rump,
  • Johannes Stegbauer,
  • Lars Schimmöller,
  • Sebastian Potthoff,
  • Claudia Schmid,
  • Sylvia Roeder,
  • Lukas Hafer,
  • Felix Mahfoud,
  • Michael Böhm,
  • Sebastian Ewen,
  • Saarraaken Kulenthiran,
  • Angelika Wachter,
  • Christina Koch,
  • Karl Fengler,
  • Karl-Philipp Rommel,
  • Kai Trautmann,
  • Roland E. Schmieder,
  • Christian Ott,
  • Axel Schmid,
  • Michael Uder,
  • Ulrike Heinritz,
  • Kerstin Fröhlich-Endres,
  • Sabine Genth-Zotz,
  • Denise Kämpfner,
  • Armin Grawe,
  • Johannes Höhne,
  • Bärbel Kaesberger,
  • Constantin von zur Mühlen,
  • Dennis Wolf,
  • Markus Welzel,
  • Gudrun Heinrichs,
  • Barbara Trabitzsch,
  • Hervé Trillaud,
  • Erika Cornu,
  • David Fouassier,
  • Aurélien Lorthioir,
  • Valérie Paquet,
  • Atul Pathak,
  • Benjamin Honton,
  • Marianne Cottin,
  • Frédéric Petit,
  • Pierre Lantelme,
  • Constance Berge,
  • Pierre-Yves Courand,
  • Fatou Langevin,
  • Benjamin Longere,
  • Guillaume Ledieu,
  • François Pontana,
  • Lida Feyz,
  • Arno Ruiter,
  • Elisabeth Huyskens,
  • Peter Blankestijn,
  • Michiel Voskuil,
  • Zwaantina Rittersma,
  • Helma Dolmans,
  • A. A. Kroon,
  • W. H. van Zwam,
  • Jeannique Vranken,
  • Claudia de Haan,
  • Alexandre Persu,
  • Jean Renkin,
  • Frédéric Maes,
  • Christophe Beauloye,
  • Jean-Philippe Lengelé,
  • Dominique Huyberechts,
  • Anne Bouvier,
  • Adam Witkowski,
  • Andrzej Januszewicz,
  • Jacek Kądziela,
  • Aleksander Prejbisj,
  • Dagmara Hering,
  • Dariusz Ciecwierz,
  • Milosz J. Jaguszewski,
  • Radoslaw Owczuk,
  • Ronald Victor,
  • Courtney Walsh,
  • Jonathan Williams,
  • Sandeep Aggarwal,
  • Scott Biedermann,
  • Jeremy Sayer,
  • Sudha Ganesh Iyer,
  • Nicholas Robinson,
  • Sadat Ali Edroos,
  • Amit Patel,
  • David Beckett,
  • Justin Davies,
  • Neil Chapman,
  • Matthew Shun Shin,
  • James Howard,
  • Andrew S. P. Sharp,
  • Anil Joseph,
  • Richard D’Souza,
  • Robert Gerber,
  • Mohamad Faris,
  • Andrew John Marshall,
  • Cristina Elorz,
  • Philipp Lurz,
  • Robert Höllriegel,
  • Karl Fengler,
  • Karl-Philipp Rommel,
  • Michael Böhm,
  • Sebastian Ewen,
  • Jelena Lucic,
  • Roland E. Schmieder,
  • Christian Ott,
  • Michael Uder,
  • Christian Rump,
  • Johannes Stegbauer,
  • Patric Kröpil

摘要

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.