Fuwai Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, China (X.J., H.D., R.G.).
Department of Cardiology and Cardiovascular Research Institute Basel, University Heart Center, University Hospital Basel, Switzerland (F.M., L.L).
Circulation. 2024 Nov 12;150(20):1588-1598. doi: 10.1161/CIRCULATIONAHA.124.069215. Epub 2024 Sep 4.
Renal denervation (RDN) can lower blood pressure (BP) in patients with hypertension in both the presence and absence of medication. This is a sham-controlled trial investigating the safety and efficacy of RDN in China.
This prospective, multicenter, randomized, patient- and outcome-assessor-blinded, sham-controlled trial investigated radiofrequency RDN in patients with hypertension on standardized triple antihypertensive therapy. Eligible patients were randomized 1:1 to undergo RDN using a multi-electrode radiofrequency catheter (Iberis; Shanghai Angiocare Medical Technology, Shanghai, China) or a sham procedure. The primary efficacy outcome was the between-group difference in baseline-adjusted change in mean 24-hour ambulatory systolic BP from randomization to 6 months.
Of 217 randomized patients (mean age, 45.3±10.2 years; 21% female), 107 were randomized to RDN and 110 were randomized to sham control. At 6 months, there was a greater reduction in 24-hour systolic BP in the RDN (-13.0±12.1 mm Hg) compared with the sham control group (-3.0±13.0 mm Hg; baseline-adjusted between-group difference, -9.4 mm Hg [95% CI, -12.8 to -5.9]; <0.001). Compared with sham, 24-hour diastolic BP was lowered by -5.0 mm Hg ([95% CI, -7.5 to -2.4]; <0.001) 6 months after RDN, and office systolic and diastolic BP was lowered by -6.4 mm Hg ([95% CI, -10.5 to -2.3]; =0.003) and -5.1 mm Hg ([95% CI, -8.2 to -2.0]; =0.001), respectively. One patient in the RDN group experienced an access site complication (hematoma), which resolved without sequelae. No other major device- or procedure-related safety events occurred through follow-up.
In this trial of Chinese patients with uncontrolled hypertension on a standardized triple pharmacotherapy, RDN was safe and reduced ambulatory and office BP at 6 months compared with sham.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT02901704.
肾去神经术（RDN）可降低高血压患者在药物治疗和不治疗的情况下的血压。这是一项在中国进行的假手术对照试验，旨在研究 RDN 的安全性和有效性。
这是一项前瞻性、多中心、随机、患者和结果评估者设盲、假手术对照试验，研究了射频 RDN 在接受标准化三联抗高血压治疗的高血压患者中的应用。符合条件的患者按 1:1 随机分为 RDN 组（使用多电极射频导管[Iberis；上海微创医疗器械（集团）有限公司，上海]）或假手术组。主要疗效终点为从随机分组到 6 个月时，基线校正后 24 小时动态收缩压的组间差异。
在 217 名随机患者（平均年龄 45.3±10.2 岁，21%为女性）中，107 名患者被随机分为 RDN 组，110 名患者被随机分为假手术对照组。6 个月时，RDN 组的 24 小时收缩压降低更明显（-13.0±12.1mmHg），而假手术对照组为（-3.0±13.0mmHg；基线校正后组间差异为-9.4mmHg[95%置信区间（CI），-12.8 至-5.9]；<0.001）。与假手术相比，RDN 治疗 6 个月后 24 小时舒张压降低 5.0mmHg（[95%CI，-7.5 至-2.4]；<0.001），诊室收缩压和舒张压分别降低 6.4mmHg（[95%CI，-10.5 至-2.3]；=0.003）和 5.1mmHg（[95%CI，-8.2 至-2.0]；=0.001）。RDN 组有 1 例患者发生入路部位并发症（血肿），无后遗症。随访期间无其他与器械或手术相关的重大安全性事件发生。
在这项接受标准化三联药物治疗的中国未控制高血压患者的试验中，与假手术相比，RDN 治疗安全，并在 6 个月时降低了动态和诊室血压。
