Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial.
Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial.
复制标题
DOI：
10.1016/s0140-6736(21)00788-1
复制
发表时间：
2021-06-26
期刊：
影响因子：
--
通讯作者：
Kirtane, Ajay J
中科院分区：
文献类型：
--
作者：
Azizi, Michel;Sanghvi, Kintur;Kirtane, Ajay J
背景技术背景：血管内肾去神经术可降低轻中度高血压患者的血压，但其在真正的顽固性高血压患者中的疗效尚未显示。我们的目的是评估血管内超声肾去神经治疗对三种或三种以上降压药物耐药的高血压患者的疗效和安全性。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，我们纳入的患者年龄在18-75岁之间，尽管使用了包括利尿剂在内的三种或更多种抗高血压药物，但诊室血压至少为140/90 mm Hg。合格的患者转换为每日一次，固定剂量，单丸组合的钙通道阻滞剂，血管紧张素受体阻滞剂，噻嗪类利尿剂。经过4周的标准化治疗后，日间动态血压至少为135/85 mm Hg的患者通过计算机（按中心分层）随机分配（1：1）至超声肾去神经或假手术组。患者和结局评估者对随机化设盲。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中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。该研究注册于ClinicalTrials.gov，NCT 02649426。结果：2016年3月11日至2020年3月13日期间，入组了989名受试者，其中136名随机分配至肾脏去神经术（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（去肾神经组51例中的42例[82%] vs假手术组57例中的47例[82%]; p= 0.99）。去肾神经术比假手术更能降低日间动态收缩压（-8统计学0 mmHg [IQR -16统计学4至0·0] vs -3统计学0 mmHg [-10统计学3至1·8];组间差异中位数-4统计学5 mmHg [95% CI -8统计学5至-0统计学3];校正p=0·022）;在具有完整动态血压数据的患者中，组间差异中位数为-5 statist 8 mm Hg（95% CI -9 statist 7 to -1 statist 6;校正后p=0·0051）。有两个groups.Interpretation之间的安全性结果没有差异：与假手术相比，超声肾去神经降低血压在2个月的高血压患者耐标准化的三联组合丸。如果肾脏去神经支配的降压效果和安全性长期维持，肾脏去神经支配可能是顽固性高血压患者进一步降压药物的替代方案。
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.