Columbia University Medical Center/NewYork-Presbyterian Hospital and the Cardiovascular Research Foundation, New York.
Associate Editor, JAMA Cardiology.
JAMA Cardiol. 2023 May 1;8(5):464-473. doi: 10.1001/jamacardio.2023.0338.
Ultrasound renal denervation (uRDN) was shown to lower blood pressure (BP) in patients with uncontrolled hypertension (HTN). Establishing the magnitude and consistency of the uRDN effect across the HTN spectrum is clinically important.
To characterize the effectiveness and safety of uRDN vs a sham procedure from individual patient-level pooled data across uRDN trials including either patients with mild to moderate HTN on a background of no medications or with HTN resistant to standardized triple-combination therapy.
A Study of the ReCor Medical Paradise System in Clinical Hypertension (RADIANCE-HTN SOLO and TRIO) and A Study of the ReCor Medical Paradise System in Stage II Hypertension (RADIANCE II) trials.
Trials with similar designs, standardized operational implementation (medication standardization and blinding of both patients and physicians to treatment assignment), and follow-up.
Pooled analysis using individual patient-level data using linear regression models to compare uRDN with sham across the trials.
The primary outcome was baseline-adjusted change in 2-month daytime ambulatory systolic BP (dASBP) between groups.
A total of 506 patients were randomized in the 3 studies (uRDN, 293; sham, 213; mean [SD] age, 54.1 [9.3]; 354 male [70.0%]). After a 1-month medication stabilization period, dASBP was similar between the groups (mean [SD], uRDN, 150.3 [9.2] mm Hg; sham, 150.8 [10.5] mm Hg). At 2 months, dASBP decreased by 8.5 mm Hg to mean (SD) 141.8 (13.8) mm Hg among patients treated with uRDN and by 2.9 mm Hg to 147.9 (14.6) mm Hg among patients treated with a sham procedure (mean difference, -5.9; 95% CI, -8.1 to -3.8 mm Hg; P < .001 in favor of uRDN). BP decreases from baseline with uRDN vs sham were consistent across trials and across BP parameters (office SBP: -10.4 mm Hg vs -3.4 mm Hg; mean difference, -6.4 mm Hg; 95% CI, -9.1 to -3.6 mm Hg; home SBP: -8.4 mm Hg vs -1.4 mm Hg; mean difference, -6.8 mm Hg; 95% CI, -8.7 to -4.9 mm Hg, respectively). The BP reductions with uRDN vs sham were consistent across prespecified subgroups. Independent predictors of a larger BP response to uRDN were higher baseline BP and heart rate and the presence of orthostatic hypertension. No differences in early safety end points were observed between groups.
Results of this patient-level pooled analysis suggest that BP reductions with uRDN were consistent across HTN severity in sham-controlled trials designed with a 2-month primary end point to standardize medications across randomized groups.
ClinicalTrials.gov Identifier: NCT02649426 and NCT03614260.
超声肾去神经术（uRDN）已被证明可降低未控制的高血压（HTN）患者的血压。在整个 HTN 谱中确定 uRDN 效应的幅度和一致性在临床上很重要。
从包括轻度至中度 HTN 且未服用药物或对标准三联组合疗法耐药的 HTN 患者的个体患者水平汇总数据中，描述 uRDN 与假手术的有效性和安全性。
ReCor Medical Paradise 系统在临床高血压中的研究（RADIANCE-HTN SOLO 和 TRIO）和 ReCor Medical Paradise 系统在 II 期高血压中的研究（RADIANCE II）。
具有相似设计、标准化操作实施（药物标准化和对治疗分配的患者和医生双盲）和随访的试验。
使用线性回归模型对个体患者水平数据进行汇总分析，比较试验中 uRDN 与假手术的差异。
主要结局是两组间 2 个月日间动态收缩压（dASBP）的基线调整变化。
共有 506 名患者被随机分为 3 项研究（uRDN，293 名；假手术，213 名；平均[SD]年龄，54.1[9.3]；354 名男性[70.0%]）。在 1 个月的药物稳定期后，两组间 dASBP 相似（平均[SD]，uRDN，150.3[9.2]mm Hg；假手术，150.8[10.5]mm Hg）。在 2 个月时，与接受假手术的患者相比，接受 uRDN 治疗的患者的 dASBP 降低了 8.5mm Hg，至 141.8[13.8]mm Hg（平均差异，-5.9；95%CI，-8.1 至-3.8mm Hg；P<0.001 支持 uRDN）。与接受假手术的患者相比，uRDN 与基线相比的 BP 下降在所有试验和 BP 参数中都是一致的（诊室 SBP：-10.4mm Hg 与-3.4mm Hg；平均差异，-6.4mm Hg；95%CI，-9.1 至-3.6mm Hg；家庭 SBP：-8.4mm Hg 与-1.4mm Hg；平均差异，-6.8mm Hg；95%CI，-8.7 至-4.9mm Hg）。uRDN 与假手术相比的 BP 降低在预设的亚组中是一致的。uRDN 血压反应较大的独立预测因素是较高的基线血压和心率以及体位性高血压的存在。两组之间未观察到早期安全性终点的差异。
这项患者水平汇总分析的结果表明，在设计 2 个月主要终点以标准化随机组药物的假对照试验中，uRDN 的血压降低与 HTN 严重程度一致。
ClinicalTrials.gov 标识符：NCT02649426 和 NCT03614260。
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