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Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial

Published on Jun 1, 2018in The Lancet59.102
· DOI :10.1016/S0140-6736(18)31082-1
Michel Azizi41
Estimated H-index: 41
(Paris V: Paris Descartes University),
Roland E. Schmieder87
Estimated H-index: 87
+ 126 AuthorsJean Renkin11
Estimated H-index: 11
Sources
Abstract
Summary Background Early studies suggest that radiofrequency-based renal denervation reduces blood pressure in patients with moderate hypertension. We investigated whether an alternative technology using endovascular ultrasound renal denervation reduces ambulatory blood pressure in patients with hypertension in the absence of antihypertensive medications. Methods RADIANCE-HTN SOLO was a multicentre, international, single-blind, randomised, sham-controlled trial done at 21 centres in the USA and 18 in Europe. Patients with combined systolic–diastolic hypertension aged 18–75 years were eligible if they had ambulatory blood pressure greater than or equal to 135/85 mm Hg and less than 170/105 mm Hg after a 4-week discontinuation of up to two antihypertensive medications and had suitable renal artery anatomy. Patients were randomised (1:1) to undergo renal denervation with the Paradise system (ReCor Medical, Palo Alto, CA, USA) or a sham procedure consisting of renal angiography only. The randomisation sequence was computer generated and stratified by centres with randomised blocks of four or six and permutation of treatments within each block. Patients and outcome assessors were blinded to randomisation. The primary effectiveness endpoint was the change in daytime ambulatory systolic blood pressure at 2 months in the intention-to-treat population. Patients were to remain off antihypertensive medications throughout the 2 months of follow-up unless specified blood pressure criteria were exceeded. Major adverse events included all-cause mortality, renal failure, an embolic event with end-organ damage, renal artery or other major vascular complications requiring intervention, or admission to hospital for hypertensive crisis within 30 days and new renal artery stenosis within 6 months. This study is registered with ClinicalTrials.gov, number NCT02649426. Findings Between March 28, 2016, and Dec 28, 2017, 803 patients were screened for eligibility and 146 were randomised to undergo renal denervation (n=74) or a sham procedure (n=72). The reduction in daytime ambulatory systolic blood pressure was greater with renal denervation (−8·5 mm Hg, SD 9·3) than with the sham procedure (−2·2 mm Hg, SD 10·0; baseline-adjusted difference between groups: −6·3 mm Hg, 95% CI −9·4 to −3·1, p=0·0001). No major adverse events were reported in either group. Interpretation Compared with a sham procedure, endovascular ultrasound renal denervation reduced ambulatory blood pressure at 2 months in patients with combined systolic–diastolic hypertension in the absence of medications. Funding ReCor Medical.
  • References (28)
  • Citations (89)
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References28
Newest
#1J.R. Banegas Banegas (UAM: Autonomous University of Madrid)H-Index: 66
#2Luis M. Ruilope (UAM: Autonomous University of Madrid)H-Index: 17
Last. Bryan Williams (UAM: Autonomous University of Madrid)H-Index: 1
view all 10 authors...
Abstract Background Evidence for the influence of ambulatory blood pressure on prognosis derives mainly from population-based studies and a few relatively small clinical investigations. This study examined the associations of blood pressure measured in the clinic (clinic blood pressure) and 24-hour ambulatory blood pressure with all-cause and cardiovascular mortality in a large cohort of patients in primary care. Methods We analyzed data from a registry-based, multicenter, national cohort that i...
158 CitationsSource
#1Joost Daemen (EUR: Erasmus University Rotterdam)H-Index: 36
#2Felix MahfoudH-Index: 49
Last. Thomas ZellerH-Index: 54
view all 10 authors...
The efficacy of first-generation radiofrequency renal denervation devices may have been limited due to incomplete circumferential denervation and dependence on individual operator technique. The Paradise Renal Denervation System (ReCor Medical, Palo Alto, CA) was designed to maximize nerve coverage
1 CitationsSource
#1Laura Mauri (Brigham and Women's Hospital)H-Index: 68
#2Kazuomi Kario (Jichi Medical University)H-Index: 65
Last. Michel Azizi (Paris V: Paris Descartes University)H-Index: 41
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Catheter-based renal denervation is a new approach to treat hypertension via modulation of the renal sympathetic nerves. Although nonrandomized and small, open-label randomized studies resulted in significant reductions in office blood pressure 6 months after renal denervation with monopolar radiofrequency catheters, the first prospective, randomized, sham-controlled study (Symplicity HTN-3) failed to meet its blood pressure efficacy end point. New clinical trials with new catheters have since b...
19 CitationsSource
#1Felix Mahfoud (MIT: Massachusetts Institute of Technology)H-Index: 49
#2Roland E. SchmiederH-Index: 87
Last. William Wijns (National University of Ireland, Galway)H-Index: 102
view all 29 authors...
The interest in RDN for hypertension has fluctuated recently, with a flurry of initial enthusiasm followed by sudden loss of interest by researchers and device manufacturers, with an almost as sudden resurgence in clinical trials activity and device innovation more recently. There is widespread consensus that this therapeutic strategy can be effective, at least for some of the technologies available. Major uncertainties remain as to the clinical role of RDN, and whether any of the emerging techn...
41 CitationsSource
#1S. Al RaisiH-Index: 4
#2Michael BarryH-Index: 10
Last. Pramesh KovoorH-Index: 22
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5 CitationsSource
#1Raymond R. Townsend (UPenn: University of Pennsylvania)H-Index: 63
#2Felix Mahfoud (MIT: Massachusetts Institute of Technology)H-Index: 49
Last. Craig ChasenH-Index: 2
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Summary Background Previous randomised renal denervation studies did not show consistent efficacy in reducing blood pressure. The objective of our study was to evaluate the effect of renal denervation on blood pressure in the absence of antihypertensive medications. Methods SPYRAL HTN-OFF MED was a multicentre, international, single-blind, randomised, sham-controlled, proof-of-concept trial. Patients were enrolled at 21 centres in the USA, Europe, Japan, and Australia. Eligible patients were dru...
176 CitationsSource
#1Roland E. SchmiederH-Index: 87
#2Christian OttH-Index: 25
Last. Melvin D. LoboH-Index: 14
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OBJECTIVES The aim of this double-blind, randomized, sham-controlled study was to verify the blood pressure (BP)-lowering efficacy of externally delivered focused ultrasound for renal denervation (RDN). BACKGROUND Nonrandomized, first proof-of-concept study and experimental evidence suggested that noninvasive techniques of RDN emerged as an alternative approach of RDN to invasive technologies. METHODS WAVE IV, an international, randomized (1 : 1) sham-controlled, double-blind prospective clinica...
11 CitationsSource
BackgroundThe DENERHTN (Renal Denervation for Hypertension) trial confirmed the efficacy of renal denervation (RDN) in lowering daytime ambulatory systolic blood pressure when added to standardized...
9 CitationsSource
#1Karl FenglerH-Index: 11
#2Robert HöllriegelH-Index: 15
Last. Philipp LurzH-Index: 28
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Introduction: The effectiveness of renal sympathetic denervation (RDN) as a treatment for therapy-resistant hypertension has been doubted as the Simplicity-HTN-3 trial was unable to show any treatment benefit over sham procedure. This might partly be explained by a high procedural variability in treatment with radiofrequency-based catheters. Recently, newer systems for RDN, like ultrasound-based devices, have been introduced into practice. To date however, data on their effectiveness for the tre...
6 CitationsSource
Resistant hypertension is highly prevalent among the general hypertensive population and the clinical management of this condition remains problematic. Different approaches, including a more intensified antihypertensive therapy, lifestyle modifications, or both, have largely failed to improve patients' outcomes and to reduce cardiovascular and renal risk. As renal sympathetic hyperactivity is a major driver of resistant hypertension, renal sympathetic ablation (renal denervation) has been recent...
12 CitationsSource
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#2Stefano Taddei (UniPi: University of Pisa)H-Index: 58
Last. Roberto PontremoliH-Index: 34
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Renal denervation is a device-based procedure for hypertension for which safety and efficacy has been demonstrated. At present, its clinical use is still matter of debate, despite the most recent clinical trials have shown promising results with new-generation devices in various hypertensive populations. This position paper was deemed necessary by the Italian Society of Arterial Hypertension, in order to provide indications about the applications of renal denervation in the clinical setting. A s...
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#1Michael Doumas (A.U.Th.: Aristotle University of Thessaloniki)H-Index: 34
#2Konstantinos Imprialos (A.U.Th.: Aristotle University of Thessaloniki)H-Index: 7
Last. Athanasios J. ManolisH-Index: 43
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The management of resistant hypertension presents several challenges in everyday clinical practice. During the past few years, several studies have been performed to identify efficient and safe pharmacological and non-pharmacological options for the management of such patients. The Spironolactone versus placebo, bisoprolol, and doxazosin to determine the optimal treatment for drug-resistant hypertension (PATHWAY-2) trial demonstrated significant benefits with the use of spinorolactone as a fourt...
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#1Mi Ra NohH-Index: 6
Last. Babu J. PadanilamH-Index: 18
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The kidney is innervated by afferent sensory and efferent sympathetic nerve fibers. Norepinephrine (NE) is the primary neurotransmitter for post-ganglionic sympathetic adrenergic nerves, and its signaling, regulated through adrenergic receptors (AR), modulates renal function and pathophysiology under disease conditions. Renal sympathetic overactivity and increased NE level are commonly seen in chronic kidney disease (CKD) and are critical factors in the progression of renal disease. Blockade of ...
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#1Felix Mahfoud (Saarland University)H-Index: 49
#2Jean RenkinH-Index: 15
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Abstract Objectives The aim of this multicenter, open-label trial was to evaluate the safety and efficacy of alcohol-mediated renal denervation using a novel catheter system (the Peregrine System Infusion Catheter) for the infusion of dehydrated alcohol as a neurolytic agent into the renal periarterial space. Background The number of hypertensive patients with uncontrolled blood pressure (BP) remains unacceptably low. The renal sympathetic nervous system has been identified as an attractive ther...
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Abstract Objectives The aim of this study was to investigate bipolar radiofrequency renal denervation in patients with hypertension not receiving medications at baseline. Background A blood pressure–reducing effect of renal denervation has been difficult to isolate in clinical investigations. Methods REDUCE HTN: REINFORCE (Renal Denervation Using the Vessix Renal Denervation System for the Treatment of Hypertension) was a randomized, sham-controlled multicenter trial. Patients with office systol...
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BACKGROUND: Increased nerve activity causes hypertension and kidney disease. Recent studies suggest that renal denervation reduces BP in patients with hypertension. Renal NE release is regulated by prejunctional alpha2A-adrenoceptors on sympathetic nerves, and alpha2A-adrenoceptors act as autoreceptors by binding endogenous NE to inhibit its own release. However, the role of alpha2A-adrenoceptors in the pathogenesis of hypertensive kidney disease is unknown. METHODS: We investigated effects of a...
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