Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial,The Lancet

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Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial
The Lancet ( IF 168.9 ) Pub Date : 2021-05-16 , DOI: 10.1016/s0140-6736(21)00788-1
Michel Azizi ₁ , Kintur Sanghvi ₂ , Manish Saxena ₃ , Philippe Gosse ₄ , John P Reilly ₅ , Terry Levy ₆ , Lars C Rump ₇ , Alexandre Persu ₈ , Jan Basile ₉ , Michael J Bloch ₁₀ , Joost Daemen ₁₁ , Melvin D Lobo ₃ , Felix Mahfoud ₁₂ , Roland E Schmieder ₁₃ , Andrew S P Sharp ₁₄ , Michael A Weber ₁₅ , Marc Sapoval ₁₆ , Pete Fong ₁₇ , Atul Pathak ₁₈ , Pierre Lantelme ₁₉ , David Hsi ₂₀ , Sripal Bangalore ₂₁ , Adam Witkowski ₂₂ , Joachim Weil ₂₃ , Benjamin Kably ₂₄ , Neil C Barman ₂₅ , Helen Reeve-Stoffer ₂₅ , Leslie Coleman ₂₅ , Candace K McClure ₂₆ , Ajay J Kirtane ₂₇ ,

Affiliation

Université de Paris, Paris, France; Hypertension Department and DMU CARTE, AP-HP Hôpital Européen Georges-Pompidou, Paris, France; INSERM, CIC1418, Paris, France.
Deborah Heart and Lung Center, Browns Mills, NJ, USA.
Barts NIHR Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, London, UK.
Hôpital Saint-André CHU, Bordeaux, France.
Ochsner Heart and Vascular Institute, New Orleans, LA, USA.
Royal Bournemouth Hospital, Bournemouth, UK.
University Clinic Dusseldorf, Dusseldorf, Germany.
Division of Cardiology, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium; Pole of Cardiovascular Research, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, Brussels, Belgium.
Seinsheimer Cardiovascular Health Program, Medical University of South Carolina, Ralph H Johnson VA Medical Center, Charleston, SC, USA.
Department of Medicine, University of Nevada School of Medicine, Vascular Care, Renown Institute of Heart and Vascular Health, Reno, NV, USA.
Erasmus MC, Department of Cardiology, University Medical Center Rotterdam, Rotterdam, Netherlands.
Klinik für Innere Medizin III, Saarland University Hospital, Homburg/Saar, Germany; Institute for Medical Engineering and Science, Massachusetts Institute of Technology, Cambridge, MA, USA.
Nephrology and Hypertension, University Hospital Erlangen, Friedrich Alexander University, Erlangen, Germany.
Cardiology Department, University Hospital of Wales, Cardiff, UK; NIHR Clinical Research Facility, University of Exeter, Exeter, UK.
Division of Cardiovascular Medicine, State University of New York, Downstate Medical Center, New York, NY, USA.
Université de Paris, Paris, France; Hypertension Department and DMU CARTE, AP-HP Hôpital Européen Georges-Pompidou, Paris, France.
Vanderbilt University Medical Center, Nashville, TN, USA.
Department of Cardiovascular Medicine, Princess Grace Hospital, Monaco; UMR UT3 CNRS 5288, University of Toulouse, Toulouse, France.
Hôpital de la Croix Rousse, Lyon, France.
Stamford Hospital, Stamford, CT, USA.
NYU School of Medicine, New York, NY, USA.
Institute of Cardiology, Warsaw, Poland.
Sana Kliniken Lübeck, Lübeck, Germany.
Université de Paris, Paris, France; AP-HP Hôpital Européen Georges-Pompidou, Pharmacology Unit and DMU CARTE, Paris, France.
ReCor Medical, Palo Alto, CA, USA.
NAMSA, Minneapolis, MN, USA.
Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, NY, USA.

Background

Endovascular renal denervation reduces blood pressure in patients with mild-to-moderate hypertension, but its efficacy in patients with true resistant hypertension has not been shown. We aimed to assess the efficacy and safety of endovascular ultrasound renal denervation in patients with hypertension resistant to three or more antihypertensive medications.

Methods

In a randomised, international, multicentre, single-blind, sham-controlled trial done at 28 tertiary centres in the USA and 25 in Europe, we included patients aged 18–75 years with office blood pressure of at least 140/90 mm Hg despite three or more antihypertensive medications including a diuretic. Eligible patients were switched to a once daily, fixed-dose, single-pill combination of a calcium channel blocker, an angiotensin receptor blocker, and a thiazide diuretic. After 4 weeks of standardised therapy, patients with daytime ambulatory blood pressure of at least 135/85 mm Hg were randomly assigned (1:1) by computer (stratified by centres) to ultrasound renal denervation or a sham procedure. Patients and outcome assessors were masked to randomisation. Addition of antihypertensive medications was allowed if specified blood pressure thresholds were exceeded. The primary endpoint was the change in daytime ambulatory systolic blood pressure at 2 months in the intention-to-treat population. Safety was also assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02649426.

Findings

Between March 11, 2016, and March 13, 2020, 989 participants were enrolled and 136 were randomly assigned to renal denervation (n=69) or a sham procedure (n=67). Full adherence to the combination medications at 2 months among patients with urine samples was similar in both groups (42 [82%] of 51 in the renal denervation group vs 47 [82%] of 57 in the sham procedure group; p=0·99). Renal denervation reduced daytime ambulatory systolic blood pressure more than the sham procedure (−8·0 mm Hg [IQR –16·4 to 0·0] vs –3·0 mm Hg [–10·3 to 1·8]; median between-group difference –4·5 mm Hg [95% CI –8·5 to –0·3]; adjusted p=0·022); the median between-group difference was –5·8 mm Hg (95% CI –9·7 to –1·6; adjusted p=0·0051) among patients with complete ambulatory blood pressure data. There were no differences in safety outcomes between the two groups.

Interpretation

Compared with a sham procedure, ultrasound renal denervation reduced blood pressure at 2 months in patients with hypertension resistant to a standardised triple combination pill. If the blood pressure lowering effect and safety of renal denervation are maintained in the long term, renal denervation might be an alternative to the addition of further antihypertensive medications in patients with resistant hypertension.

Funding

ReCor Medical.

中文翻译：

超声去肾神经支配对三联药丸耐药的高血压（RADIANCE-HTN TRIO）：一项随机、多中心、单盲、假对照试验

背景

血管内肾去神经支配可降低轻度至中度高血压患者的血压，但尚未显示其对真正顽固性高血压患者的疗效。我们的目的是评估血管内超声去肾神经支配对三种或三种以上降压药耐药的高血压患者的疗效和安全性。

方法

在美国 28 个三级中心和欧洲 25 个三级中心进行的一项随机、国际、多中心、单盲、假对照试验中，我们纳入了 18-75 岁、诊室血压至少为 140/90 mmHg 的患者，尽管三种或多种抗高血压药物，包括利尿剂。符合条件的患者被转换为每日一次、固定剂量、单片钙通道阻滞剂、血管紧张素受体阻滞剂和噻嗪类利尿剂的组合。经过 4 周的标准化治疗后，日间动态血压至少为 135/85 mmHg 的患者通过计算机（按中心分层）被随机分配（1:1）接受超声肾去神经支配或假手术。患者和结果评估者被随机分组。如果超过规定的血压阈值，则允许添加抗高血压药物。主要终点是意向治疗人群在 2 个月时日间动态收缩压的变化。还在意向治疗人群中评估了安全性。该研究已在 ClinicalTrials.gov 注册，NCT02649426。

发现

在 2016 年 3 月 11 日至 2020 年 3 月 13 日期间，共有 989 名参与者入组，其中 136 名被随机分配接受去肾神经（n=69）或假手术（n=67）。两组患者在 2 个月时对联合用药的完全依从性相似（肾去神经支配组 51 人中的 42 人 [82%]与假手术组 57 人中的 47 人 [82%]；p=0· 99)。去肾神经支配比假手术更能降低日间动态收缩压（−8·0 mm Hg [IQR –16·4 到 0·0] vs–3·0 毫米汞柱 [–10·3 至 1·8]；组间差异中位数 –4·5 mm Hg [95% CI –8·5 至 –0·3]；调整后的 p=0·022)；在具有完整动态血压数据的患者中，组间差异的中位数为 –5·8 mm Hg（95% CI –9·7 至 –1·6；调整后的 p=0·0051）。两组之间的安全性结果没有差异。