在SYMPLICITY临床试验项目中对肾交感神经射频消融术进行的长期、患者层面分析
Long-Term, Patient-Level Analysis of Radiofrequency Renal Denervation in the SYMPLICITY Clinical Trial Program.
作者信息
Mahfoud Felix, Townsend Raymond R, Kandzari David E, Mancia Giuseppe, Whitbourn Robert, Lauder Lucas, Bhatt Deepak L, Kario Kazuomi, Schmieder Roland E, Schlaich Markus, Fahy Martin, Böhm Michael
机构信息
Department of Cardiology, University Heart Center, University Hospital Basel, Basel, Switzerland; Cardiovascular Research Institute Basel (CRIB), University Heart Center, University Hospital Basel, Basel, Switzerland.
Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
出版信息
JACC Adv. 2025 Mar;4(3):101606. doi: 10.1016/j.jacadv.2025.101606. Epub 2025 Feb 21.
BACKGROUND
Renal denervation (RDN) lowers blood pressure (BP) in patients with uncontrolled hypertension. Current guidelines recommend RDN for patients with uncontrolled BP despite the use of antihypertensive (AH) medications. Durability of BP reductions and assessment of which patient baseline characteristics correlate with subsequent BP reductions are scarce.
OBJECTIVES
The authors leveraged patient data from the entire SYMPLICITY Clinical program to model long-term BP reductions and assess patient characteristics associated with future BP reductions.
METHODS
Repeated BP measurements from each patient were analyzed using linear mixed models. Models were fitted with office systolic BP (SBP), 24-h ambulatory SBP, office diastolic BP (DBP), and 24-h ambulatory DBP as outcome variables. Baseline BP, baseline number of AH medications, AH medications over time, and other variables were included as fixed effects.
RESULTS
The mixed model included data from 4,155 patients treated with the Symplicity RDN system. The mean age was 60 ± 12 years, 40.4% of whom were female. Estimated, longitudinal office and 24-h ambulatory SBP changes through 36 months, after adjusting for AH medication effects, were biphasic, with a steep reduction after RDN through the first 6 months followed by continuous and steady reductions in office and 24-h SBP and DBP afterward through 36 months. Higher baseline office systolic or 24-h ambulatory SBP were correlated with greater reductions through follow-up in office and 24-h SBP, respectively. Patient characteristics consistent with high sympathetic nerve activity, such as atrial fibrillation and type 2 diabetes, emerged as statistically significant covariates associated with greater office systolic and office and 24-h diastolic BP reductions, respectively.
CONCLUSIONS
Modeling suggested patients have durable BP reductions following RDN, with a steep immediate reduction followed by a steady reduction through 3 years.
背景
肾去神经支配术(RDN)可降低血压控制不佳患者的血压(BP)。当前指南推荐,对于尽管使用了抗高血压(AH)药物但血压仍控制不佳的患者,可采用RDN治疗。关于血压降低的持久性以及哪些患者基线特征与随后的血压降低相关的评估较少。
目的
作者利用整个SYMPLICITY临床项目中的患者数据,对长期血压降低情况进行建模,并评估与未来血压降低相关的患者特征。
方法
使用线性混合模型分析每位患者的重复血压测量值。模型以诊室收缩压(SBP)、24小时动态收缩压、诊室舒张压(DBP)和24小时动态舒张压作为结果变量进行拟合。将基线血压、AH药物的基线数量、随时间变化的AH药物以及其他变量作为固定效应纳入模型。
结果
混合模型纳入了4155例接受Symplicity RDN系统治疗的患者的数据。平均年龄为60±12岁,其中40.4%为女性。在调整AH药物作用后,估计的36个月内诊室和24小时动态SBP的纵向变化呈双相性,RDN术后的前6个月血压急剧下降,随后诊室和24小时SBP及DBP在接下来的36个月内持续稳定下降。较高的基线诊室收缩压或24小时动态SBP分别与随访期间诊室和24小时SBP的更大降幅相关。与高交感神经活动一致的患者特征,如心房颤动和2型糖尿病,分别成为与更大的诊室收缩压降幅以及诊室和24小时舒张压降幅相关的统计学显著协变量。
结论
建模结果表明,患者在接受RDN后血压会持续降低,术后立即急剧下降,随后在3年内稳步下降。