Effects of Renal Denervation vs Sham in Resistant Hypertension After Medication Escalation
- Type de publi. : Article dans une revue
- Date de publi. : 01/12/2022
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Auteurs :
Michel AziziFelix MahfoudMichael A WeberAndrew S P SharpRoland E SchmiederPhilipp LurzMelvin D LoboNaomi D L FisherJoost DaemenMichael J BlochJan BasileKintur SanghviManish SaxenaPhilippe GosseJ. Stephen JenkinsTerry LevyAlexandre PersuBenjamin KablyLisa ClaudeHelen Reeve-StofferCandace McclureAjay J KirtaneChristopher MullinLisa ThackerayGlenn ChertowThomas KahanHarold DauermanSteven UlleryJ. Dawn AbbottAndreas LoeningRon ZagoriaJohn CostelloCourtney KrathanLuot LewisAndrew McelvarrJohn ReillyMichael CashShannon WilliamsMaria JarvisPete FongCheryl LafferJames GainerMark RobbinsSherron CrookSarita MaddelDavid HsiScott MartinEdward PortnayMaryanne DuceySuzanne RoseElizabeth DelmastroSripal BangaloreStephen WilliamsStanley CabosCarolina Rodriguez AlvarezThomas TodoranEric PowersEmily HodskinsVijay PaladuguAnna TecklenburgChandan DevireddyJanice LeaBryan WellsAmanda FiebachClaudia MerlinFlorian RaderSuhail DohadHyun-Min KimMohammad RashidJosephine AbrahamTheophilus OwanAnu AbrahamIran LavasaniHailey NeilsonDavid CalhounThomas McelderryWilliam MaddoxSuzanne OparilSheila KinderJai RadhakrishnanCandido BatresSuzanne EdwardsJoseph GarasicDoug DrachmanRandy ZusmanKenneth RosenfieldDanny DoMatheen KhuddusSuzanne ZentkoJames O'MearaIlie BarbAbby FosterAlice BoyetteYale WangDesmond JayNedaa SkeikRobert SchwartzRose PetersonJo Anne GoldmanJessie GoldmanGary LedleyNancy KatofSrinivasa PotluriScott BiedermannJacquelyn WardMegan WhiteLaura MauriPiotr SobieszczkyAlex SmithLaura AseltineRick StoufferAlan HinderliterEric PauleyTyrone WadeDavid ZidarMehdi ShishehborBarry EffronMarco CostaTerence SemenecChanwit RoongsritongPriscilla NelsonBridget NeumannDebbie CohenJay GiriRobin NeubauerThu VoAtul R ChughPei-Hsiu HuangPowell JoseJohn FlackRobert FishmanMichael JonesTodd AdamsChristopher BajzerAnthony MathurAjay JainArmida BalawonOlivier ZongoClare BentDavid BeckettNicki LakemanSarah KennardRichard J D’souzaSarah StattonLindsay WilkesChristine AnningJeremy SayerSudha Ganesh IyerNicholas RobinsonAnnaliza SevillanoMadelaine OcampoRobert GerberMohamad FarisAndrew John MarshallJanet SinclairHayley PepperJustin DaviesNeil ChapmanPaula BurakPaula CarvelliSachin JadhavJane QuinnLars Christian RumpJohannes StegbauerLars SchimmöllerSebastian PotthoffClaudia SchmidSylvia RoederJoachim WeilLukas HaferTolga AgdirliogluTanja KöllnerMichael BöhmSebastian EwenSaarraaken KulenthiranAngelika WachterChristina KochKarl FenglerKarl-Philipp RommelKai TrautmannMartin PetzoldChristian OttAxel SchmidMichael UderUlrike HeinritzKerstin Fröhlich-EndresSabine Genth-ZotzDenise KämpfnerArmin GraweJohannes HöhneBärbel KaesbergerConstantin von Zur MühlenDennis WolfMarkus WelzelGudrun HeinrichsBarbara TrabitzschAntoine CremerHervé TrillaudPanteleimon PapadopoulosFlorent MaireJulie GaudissardMarc SapovalMarine LivrozetAurélien LorthioirLaurence AmarValérie PaquetAtul PathakBenjamin HontonMarianne CottinFrédéric PetitPierre LantelmeConstance BergePierre-Yves CourandFatou LangevinPascal DelsartBenjamin LongereGuillaume LedieuFrançois PontanaCoralie SommevilleFabien BertrandLida FeyzVictor ZeijenArno RuiterElisabeth HuyskenPeter BlankestijnMichiel VoskuilZwaantina RittersmaHelma DolmansA.A. KroonW.H. van ZwamJeannique VrankenClaudia de Haan.Jean RenkinFrédéric MaesChristophe BeauloyeJean-Philippe LengeléDominique HuyberechtsAnne BouvieAdam WitkowskiAndrzej JanuszewiczJacek KądzielaAleksander PrejbisjDagmara HeringDariusz CiecwierzMilosz J JaguszewskiRadoslaw Owczuk
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Organismes :
CIC - HEGP
Hôpital Européen Georges Pompidou [APHP]
CArdiovasculaire Rénal Transplantation nEurovasculaire [Paris]
Universität des Saarlandes [Saarbrücken] = Saarland University [Saarbrücken]
SUNY Downstate Medical Center
University Hospital of Wales
University of Exeter
Universitätsklinikum Erlangen [Erlangen]
Leipzig University / Universität Leipzig
Queen Mary University of London
Brigham & Women’s Hospital [Boston]
Erasmus University Medical Center [Rotterdam]
University of Nevada [Reno]
Medical University of South Carolina [Charleston]
Queen Mary University of London
Hôpital Saint-André [Bordeaux]
Royal Bournemouth Hospital
Université Catholique de Louvain = Catholic University of Louvain
Cliniques Universitaires Saint-Luc [Bruxelles]
Hôpital Européen Georges Pompidou [APHP]
ReCor Medical Inc
Columbia University Medical Center
Danderyds sjukhus = Danderyd University Hospital
University of Vermont [Burlington]
Stanford University
Argolyn Bioscience, Inc.
- Publié dans JAMA Cardiology le 25/10/2020
Résumé : Importance Although early trials of endovascular renal denervation (RDN) for patients with resistant hypertension (RHTN) reported inconsistent results, ultrasound RDN (uRDN) was found to decrease blood pressure (BP) vs sham at 2 months in patients with RHTN taking stable background medications in the Study of the ReCor Medical Paradise System in Clinical Hypertension (RADIANCE-HTN TRIO) trial. Objectives To report the prespecified analysis of the persistence of the BP effects and safety of uRDN vs sham at 6 months in conjunction with escalating antihypertensive medications. Design, Setting, and Participants This randomized, sham-controlled, clinical trial with outcome assessors and patients blinded to treatment assignment, enrolled patients from March 11, 2016, to March 13, 2020. This was an international, multicenter study conducted in the US and Europe. Participants with daytime ambulatory BP of 135/85 mm Hg or higher after 4 weeks of single-pill triple-combination treatment (angiotensin-receptor blocker, calcium channel blocker, and thiazide diuretic) with estimated glomerular filtration rate (eGFR) of 40 mL/min/1.73 m 2 or greater were randomly assigned to uRDN or sham with medications unchanged through 2 months. From 2 to 5 months, if monthly home BP was 135/85 mm Hg or higher, standardized stepped-care antihypertensive treatment starting with aldosterone antagonists was initiated under blinding to treatment assignment. Interventions uRDN vs sham procedure in conjunction with added medications to target BP control. Main Outcomes and Measures Six-month change in medications, change in daytime ambulatory systolic BP, change in home systolic BP adjusted for baseline BP and medications, and safety. Results A total of 65 of 69 participants in the uRDN group and 64 of 67 participants in the sham group (mean [SD] age, 52.4 [8.3] years; 104 male [80.6%]) with a mean (SD) eGFR of 81.5 (22.8) mL/min/1.73 m 2 had 6-month daytime ambulatory BP measurements. Fewer medications were added in the uRDN group (mean [SD], 0.7 [1.0] medications) vs sham (mean [SD], 1.1 [1.1] medications; P = .045) and fewer patients in the uRDN group received aldosterone antagonists at 6 months (26 of 65 [40.0%] vs 39 of 64 [60.9%]; P = .02). Despite less intensive standardized stepped-care antihypertensive treatment, mean (SD) daytime ambulatory BP at 6 months was 138.3 (15.1) mm Hg with uRDN vs 139.0 (14.3) mm Hg with sham (additional decreases of −2.4 [16.6] vs −7.0 [16.7] mm Hg from month 2, respectively), whereas home SBP was lowered to a greater extent with uRDN by 4.3 mm Hg (95% CI, 0.5-8.1 mm Hg; P = .03) in a mixed model adjusting for baseline and number of medications. Adverse events were infrequent and similar between groups. Conclusions and Relevance In this study, in patients with RHTN initially randomly assigned to uRDN or a sham procedure and who had persistent elevation of BP at 2 months after the procedure, standardized stepped-care antihypertensive treatment escalation resulted in similar BP reduction in both groups at 6 months, with fewer additional medications required in the uRDN group. Trial Registration ClinicalTrials.gov Identifier: NCT02649426
Fichiers liés :
2022-Azizi-JAMA cardiology.pdf
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