超声去肾交感神经治疗高血压的 RADIANCE-HTN SOLO 试验盲态期 12 个月结果
12-Month Results From the Unblinded Phase of the RADIANCE-HTN SOLO Trial of Ultrasound Renal Denervation.
机构信息
Université de Paris, Paris, France; AP-HP, Hôpital Européen Georges-Pompidou, Hypertension Department and DMU CARTE, Paris, France; INSERM, CIC1418, Paris, France.
Erasmus Medical Center, University Medical Center Rotterdam, Department of Cardiology, Rotterdam, the Netherlands.
出版信息
JACC Cardiovasc Interv. 2020 Dec 28;13(24):2922-2933. doi: 10.1016/j.jcin.2020.09.054.
OBJECTIVES
This study reports the 12-month results of the RADIANCE-HTN (A Study of the ReCor Medical Paradise System in Clinical Hypertension) SOLO trial following unblinding of patients at 6 months.
BACKGROUND
The blood pressure (BP)-lowering efficacy and safety of endovascular ultrasound renal denervation (RDN) in the absence (2 months) and presence (6 months) of antihypertensive medications were previously reported.
METHODS
Patients with daytime ambulatory BP ≥135/85 mm Hg after 4 weeks off medication were randomized to RDN (n = 74) or sham (n = 72) and maintained off medication for 2 months. A standardized medication escalation protocol was instituted between 2 and 5 months (blinded phase). Between 6 and 12 months (unblinded phase), patients received antihypertensive medications at physicians' discretion. Outcomes at 12 months included medication burden, change in daytime ambulatory systolic BP (dASBP) and office or home systolic BP (SBP), visit-to-visit variability in SBP, and safety.
RESULTS
Sixty-five of 74 RDN patients and 67 of 72 sham patients had 12-month dASBP measurements. The proportion of patients on ≥2 medications (27.7% vs. 44.8%; p = 0.041), the number of medications (0 vs. 1.4; p = 0.015), and defined daily dose (1.4 vs. 2.2; p = 0.007) were less with RDN versus sham. The decrease in dASBP from baseline in the RDN group (-16.5 ± 12.9 mm Hg) remained stable at 12 months. The RDN versus sham adjusted difference at 12 months was -2.3 mm Hg (95% confidence interval [CI]: -5.9 to 1.3 mm Hg; p = 0.201) for dASBP, -6.3 mm Hg (95% CI: -11.1 to -1.5 mm Hg; p = 0.010) for office SBP, and -3.4 mm Hg (95% CI: -6.9 to 0.1 mm Hg; p = 0.062) for home SBP. Visit-to-visit variability in SBP was smaller in the RDN group. No renal artery injury was detected on computed tomographic or magnetic resonance angiography.
CONCLUSIONS
Despite unblinding, the BP-lowering effect of RDN was maintained at 12 months with fewer prescribed medications compared with sham.
目的
本研究报告了 ReCor 医疗天堂系统在临床高血压中的应用（RADIANCE-HTN 研究）在患者 6 个月时揭盲后的 12 个月结果。
背景
先前报道了血管内超声肾去神经术（RDN）在无（2 个月）和有（6 个月）降压药物情况下降低血压的疗效和安全性。
方法
经过 4 周停药后白天动态血压（ABP）≥135/85mmHg 的患者随机分为 RDN 组（n=74）或假手术组（n=72），并保持停药 2 个月。在 2 至 5 个月期间（盲法阶段）采用标准化药物递增方案。在 6 至 12 个月（非盲法阶段）期间，患者根据医生的建议服用降压药物。12 个月的主要结局包括药物负担、白天动态收缩压（dASBP）和诊室或家庭收缩压（SBP）的变化、SBP 随访间变异性以及安全性。
结果
74 例 RDN 患者和 72 例假手术患者中有 65 例完成了 12 个月的 dASBP 测量。与假手术组相比，RDN 组接受≥2 种药物（27.7% vs. 44.8%；p=0.041）、药物数量（0 与 1.4；p=0.015）和定义日剂量（1.4 与 2.2；p=0.007）更少。RDN 组的 dASBP 自基线下降（-16.5±12.9mmHg）在 12 个月时保持稳定。RDN 组与假手术组在 12 个月时的调整差异为-2.3mmHg（95%置信区间：-5.9 至 1.3mmHg；p=0.201），dASBP 为-6.3mmHg（95%置信区间：-11.1 至-1.5mmHg；p=0.010），诊室 SBP 为-3.4mmHg（95%置信区间：-6.9 至 0.1mmHg；p=0.062）。SBP 的随访间变异性在 RDN 组中较小。计算机断层扫描或磁共振血管造影未发现肾动脉损伤。
结论
尽管揭盲，与假手术相比，RDN 的降压效果在 12 个月时仍保持不变，且处方药物更少。
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