Fisher Naomi D L, Kirtane Ajay J
Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Boston, MA, USA.
Harvard Medical School, Boston, MA, USA.
Nat Rev Cardiol. 2025 Jan 2. doi: 10.1038/s41569-024-01104-z.
Innovative therapies for hypertension are desperately needed given the rising prevalence and falling rates of control of hypertension despite an abundance of available medical therapies. Procedural interventions lower blood pressure without depending on adherence to medications, and endovascular renal denervation (RDN) is the interventional procedure with the best evidence base for the treatment of hypertension. After nearly two decades of study, with major refinements to devices, technique and trial design, two different systems for RDN received approval from the FDA in late 2023 for the treatment of hypertension. These decisions were based on a portfolio of sham-controlled clinical trials demonstrating efficacy and safety of both radiofrequency and ultrasound RDN in treating patients across the spectrum of hypertension, including patients with mild disease taking no or one medication as well as those with moderate and truly resistant hypertension. In this Review, we begin by summarizing the background and scope of the global problem of hypertension control and explore the evolution and mechanism of RDN. We then detail early studies and randomized clinical trials demonstrating the efficacy and safety of RDN procedures, review international statements, and provide practical guidance on patient selection and implementation of RDN, including the crucial aspects of building a hypertension team and of involving patients in shared decision-making.
鉴于高血压患病率不断上升且控制率不断下降,尽管有大量可用的药物治疗方法,但仍迫切需要创新的高血压治疗方法。程序干预可降低血压,且不依赖于药物依从性,而血管内肾去神经支配术(RDN)是治疗高血压证据最充分的介入手术。经过近二十年的研究,随着设备、技术和试验设计的重大改进,两种不同的RDN系统于2023年底获得美国食品药品监督管理局(FDA)批准用于治疗高血压。这些决定基于一系列假手术对照临床试验,这些试验证明了射频和超声RDN在治疗各种高血压患者中的有效性和安全性,包括未服用药物或仅服用一种药物的轻度疾病患者以及中度和真正难治性高血压患者。在本综述中,我们首先总结高血压控制这一全球问题的背景和范围,并探讨RDN的发展历程和机制。然后,我们详细介绍了早期研究和随机临床试验,这些研究证明了RDN手术的有效性和安全性,回顾了国际声明,并为RDN的患者选择和实施提供了实用指导,包括组建高血压治疗团队以及让患者参与共同决策的关键方面。