Soleimani Hamidreza, Sattartabar Babak, Parastooei Bahar, Eshraghi Reza, Nazari Roozbeh, Najdaghi Soroush, Hobaby Sara, Etemadi Ali, Mahalleh Mehrdad, Taheri Maryam, Hernandez Adrian V, Kuno Toshiki, Taheri Homa, Siegel Robert J, Rader Florian, Tehrani Behnam N, Mandegar Mohammad Hossein, Safaee Ehsan, Ebrahimi Pouya, Hosseini Kaveh
Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.
Tehran Heart Center, Cardiovascular Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
Clin Cardiol. 2025 Mar;48(3):e70104. doi: 10.1002/clc.70104.
Although some guidelines recommend Renal denervation (RDN) as an alternative to anti-HTN medications, there are concerns about its efficacy and safety. We aimed to evaluate the benefits and harms of RDN in a systematic review and meta-analysis of sham-controlled randomized clinical trials (RCT).
Databases were searched until September 10th, 2024, to identify RCTs evaluating RDN for treating URH versus sham control. The primary outcomes were the change in office and ambulatory 24-h systolic (SBP) and diastolic blood pressure (DBP). Secondary outcomes were changes in daytime and nighttime SBP and DBP, home BP, number of anti-HTN drugs, and related complications. Mean differences (MD) and relative risks (RR) described the effects of RDN on BP and complications, respectively, using random effects meta-analyses. GRADE methodology was used to assess the certainty of evidence (COE).
We found 16 included sham-controlled RCTs [RDN (n = 1594) vs. sham (n = 1225)]. RDN significantly reduced office SBP (MD -4.26 mmHg, 95% CI: -5.68 to -2.84), 24 h ambulatory SBP (MD -2.63 mmHg), office DBP (MD -2.15 mmHg), 24-h ambulatory DBP (MD -1.27 mmHg), and daytime SBP and DBP (MD -3.29 and 2.97 mmHg), compared to the sham. The rate of severe complications was low in both groups (0%-2%). The heterogeneity was high among most indices, and CoE was very low for most outcomes.
RDN significantly reduced several SBP and DBP outcomes versus sham without significantly increasing complications. This makes RDN a potentially effective alternative to medications in URH.
尽管一些指南推荐肾去神经支配术（RDN）作为抗高血压药物的替代方法，但人们对其疗效和安全性仍存在担忧。我们旨在通过对假手术对照随机临床试验（RCT）进行系统评价和荟萃分析，评估RDN的益处和危害。
检索数据库至2024年9月10日，以确定评估RDN治疗难治性高血压（URH）与假手术对照的RCT。主要结局为诊室和动态24小时收缩压（SBP）及舒张压（DBP）的变化。次要结局为日间和夜间SBP及DBP、家庭血压、抗高血压药物数量及相关并发症的变化。采用随机效应荟萃分析，均值差（MD）和相对风险（RR）分别描述RDN对血压和并发症的影响。采用GRADE方法评估证据确定性（COE）。
我们纳入了16项假手术对照RCT[RDN组（n = 1594）与假手术组（n = 1225）]。与假手术组相比，RDN显著降低了诊室SBP（MD -4.26 mmHg，95%CI：-5.68至-2.84）、24小时动态SBP（MD -2.63 mmHg）、诊室DBP（MD -2.15 mmHg）、24小时动态DBP（MD -1.27 mmHg）以及日间SBP和DBP（MD -3.29和-2.97 mmHg）。两组严重并发症发生率均较低（0%-2%）。大多数指标的异质性较高，大多数结局的证据确定性很低。
与假手术相比，RDN显著降低了多个SBP和DBP结局，且未显著增加并发症。这使得RDN成为URH中一种潜在有效的药物替代方法。
