Azizi Michel, Schmieder Roland E, Mahfoud Felix, Weber Michael A, Daemen Joost, Lobo Melvin D, Sharp Andrew S P, Bloch Michael J, Basile Jan, Wang Yale, Saxena Manish, Lurz Philipp, Rader Florian, Sayer Jeremy, Fisher Naomi D L, Fouassier David, Barman Neil C, Reeve-Stoffer Helen, McClure Candace, Kirtane Ajay J
Université Paris-Descartes, France (M.A., D.F.).
AP-HP, Department of Hypertension, Hôpital Européen Georges-Pompidou, Paris, France (M.A., D.F.).
Circulation. 2019 May 28;139(22):2542-2553. doi: 10.1161/CIRCULATIONAHA.119.040451. Epub 2019 Mar 17.
The multicenter, international, randomized, blinded, sham-controlled RADIANCE-HTN SOLO trial (A Study of the ReCor Medical Paradise System in Clinical Hypertension) demonstrated a 6.3 mm Hg greater reduction in daytime ambulatory systolic blood pressure (BP) at 2 months by endovascular ultrasound renal denervation (RDN) compared with a sham procedure among patients not treated with antihypertensive medications. We report 6-month results after the addition of a recommended standardized stepped-care antihypertensive treatment to the randomized endovascular procedure under continued blinding to initial treatment.
Patients with a daytime ambulatory BP ≥135/85 mm Hg and <170/105 mm Hg after a 4-week discontinuation of up to 2 antihypertensive medications, and a suitable renal artery anatomy, were randomized to RDN (n=74) or sham (n=72). Patients were to remain off antihypertensive medications throughout the first 2 months of follow-up unless safety BP criteria were exceeded. Between 2 and 5 months, if monthly measured home BP was ≥135/85 mm Hg, a standardized stepped-care antihypertensive treatment was recommended consisting of the sequential addition of amlodipine (5 mg/d), a standard dose of an angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, and hydrochlorothiazide (12.5 mg/d), followed by the sequential uptitration of hydrochlorothiazide (25 mg/d) and amlodipine (10 mg/d). Outcomes included the 6-month (1) change in daytime ambulatory systolic BP adjusted for medications and baseline systolic BP, (2) medication burden, and (3) safety.
A total of 69/74 RDN patients and 71/72 sham patients completed the 6-month ambulatory BP measurement. At 6 months, 65.2% of patients in the RDN group were treated with the standardized stepped-care antihypertensive treatment versus 84.5% in the sham group (=0.008), and the average number of antihypertensive medications and defined daily dose were less in the RDN group than in the sham group (0.9±0.9 versus 1.3±0.9, =0.010 and 1.4±1.5 versus 2.0±1.8, =0.018; respectively). Despite less intensive standardized stepped-care antihypertensive treatment, RDN reduced daytime ambulatory systolic BP to a greater extent than sham (-18.1±12.2 versus -15.6±13.2 mm Hg, respectively; difference adjusted for baseline BP and number of medications: -4.3 mm Hg, 95% confidence interval, -7.9 to -0.6, =0.024). There were no major adverse events in either group through 6 months.
The BP-lowering effect of endovascular ultrasound RDN was maintained at 6 months with less prescribed antihypertensive medications compared with a sham control.
URL: https://www.
gov. Unique identifier: NCT02649426.
多中心、国际、随机、双盲、假手术对照的RADIANCE-HTN SOLO试验（ReCor Medical Paradise系统用于临床高血压的研究）表明，在未接受抗高血压药物治疗的患者中，与假手术相比，血管内超声肾去神经支配（RDN）在2个月时使日间动态收缩压（BP）降低幅度多6.3 mmHg。我们报告在继续对初始治疗设盲的情况下，在随机血管内手术基础上增加推荐的标准化阶梯式护理抗高血压治疗后的6个月结果。
在停用最多2种抗高血压药物4周后，日间动态BP≥135/85 mmHg且<170/105 mmHg，且肾动脉解剖结构合适的患者，被随机分为RDN组（n = 74）或假手术组（n = 72）。在随访的前2个月，患者应停用抗高血压药物，除非超过安全BP标准。在2至5个月期间，如果每月测量的家庭BP≥135/85 mmHg，则推荐标准化阶梯式护理抗高血压治疗，包括依次加用氨氯地平（5 mg/d）、标准剂量的血管紧张素转换酶抑制剂/血管紧张素受体阻滞剂和氢氯噻嗪（12.5 mg/d），随后依次增加氢氯噻嗪（25 mg/d）和氨氯地平（10 mg/d）的剂量。结果包括6个月时：（1）经药物和基线收缩压调整后的日间动态收缩压变化；（2）药物负担；（3）安全性。
共有69/74例RDN患者和71/72例假手术患者完成了6个月的动态BP测量。在6个月时，RDN组65.2%的患者接受了标准化阶梯式护理抗高血压治疗，而假手术组为84.5%（P = 0.008），RDN组抗高血压药物的平均数量和限定日剂量低于假手术组（分别为0.9±0.9对1.3±0.9，P = 0.010；1.4±1.5对2.0±1.8，P = 0.018）。尽管RDN组的标准化阶梯式护理抗高血压治疗强度较低，但与假手术相比，RDN使日间动态收缩压降低的幅度更大（分别为-18.1±12.2对-15.6±13.2 mmHg；经基线BP和药物数量调整后的差异：-4.3 mmHg，95%置信区间，-7.9至-0.6，P = 0.024）。两组在6个月内均未发生重大不良事件。
与假手术对照相比，血管内超声RDN的降压效果在6个月时得以维持，且开具的抗高血压药物较少。
网址：https://www.
gov。唯一标识符：NCT02649426。
