Université Paris-Descartes, Paris, France; Hypertension Department and DHU PARC, Hôpital Européen Georges-Pompidou, AP-HP, Paris, France; INSERM CIC1418, Paris, France.
Nephrology and Hypertension, University Hospital Erlangen, Friedrich Alexander University, Erlangen, Germany.
Lancet. 2018 Jun 9;391(10137):2335-2345. doi: 10.1016/S0140-6736(18)31082-1. Epub 2018 May 23.
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.
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.
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.
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.
ReCor Medical.
早期研究表明，基于射频的肾脏去神经支配可降低中度高血压患者的血压。我们研究了一种使用血管内超声肾脏去神经支配的替代技术是否可以在没有抗高血压药物的情况下降低高血压患者的动态血压。
RADIANCE-HTN SOLO 是一项多中心、国际、单盲、随机、假对照试验，在美国的 21 个中心和欧洲的 18 个中心进行。如果患者在停止使用两种降压药物 4 周后，动态血压大于或等于 135/85mmHg，且小于 170/105mmHg，且适合进行肾动脉解剖，则有资格参加合并收缩期-舒张期高血压的年龄在 18-75 岁的患者。患者被随机（1:1）接受天堂系统（ReCor Medical，美国帕洛阿尔托）进行肾去神经支配或仅进行肾血管造影的假手术。随机序列由计算机生成，并按中心分层，随机块为 4 或 6，每个块内的治疗方法进行置换。患者和结局评估者对随机分组不知情。主要疗效终点是意向治疗人群中 2 个月时日间动态收缩压的变化。除非血压标准超标，否则患者在随访的 2 个月内应继续停用降压药物。主要不良事件包括全因死亡率、肾衰竭、伴有靶器官损害的栓塞事件、需要介入治疗的肾动脉或其他主要血管并发症、30 天内因高血压危象入院和 6 个月内新发肾动脉狭窄。本研究在 ClinicalTrials.gov 注册，编号为 NCT02649426。
2016 年 3 月 28 日至 2017 年 12 月 28 日，共有 803 名患者接受了资格筛选，其中 146 名患者被随机分为肾去神经支配组（n=74）或假手术组（n=72）。与假手术组相比，肾去神经支配组的日间动态收缩压降低幅度更大（-8.5mmHg，标准差 9.3mmHg），而假手术组为-2.2mmHg，标准差 10.0mmHg（组间基线调整差异：-6.3mmHg，95%CI-9.4 至-3.1，p=0.0001）。两组均未报告重大不良事件。
与假手术相比，在无药物治疗的情况下，血管内超声肾脏去神经支配可在合并收缩期-舒张期高血压的患者中在 2 个月时降低动态血压。
ReCor Medical。
