Sharp Andrew S P, Cao Khoa N, Esler Murray D, Kandzari David E, Lobo Melvin D, Schmieder Roland E, Pietzsch Jan B
Department of Cardiology, University Hospital of Wales and Cardiff University, Cardiff, CF14 4XW, UK.
Wing Tech Inc., Menlo Park, CA 94025, USA.
Eur Heart J Qual Care Clin Outcomes. 2024 Dec 19;10(8):698-708. doi: 10.1093/ehjqcco/qcae001.
Catheter-based radiofrequency renal denervation (RF RDN) has recently been approved for clinical use in the European Society of Hypertension guidelines and by the US Food and Drug Administration. This study evaluated the lifetime cost-effectiveness of RF RDN using contemporary evidence.
A decision-analytic model based on multivariate risk equations projected clinical events, quality-adjusted life years (QALYs), and costs. The model consisted of seven health states: hypertension alone, myocardial infarction (MI), other symptomatic coronary artery disease, stroke, heart failure (HF), end-stage renal disease, and death. Risk reduction associated with changes in office systolic blood pressure (oSBP) was estimated based on a published meta-regression of hypertension trials. The base case effect size of -4.9 mmHg oSBP (observed vs. sham control) was taken from the SPYRAL HTN-ON MED trial of 337 patients. Costs were based on National Health Service England data. The incremental cost-effectiveness ratio (ICER) was evaluated against the UK National Institute for Health and Care Excellence (NICE) cost-effectiveness threshold of £20 000-30 000 per QALY gained. Extensive scenario and sensitivity analyses were conducted, including the ON-MED subgroup on three medications and pooled effect sizes. RF RDN resulted in a relative risk reduction in clinical events over 10 years (0.80 for stroke, 0.88 for MI, 0.72 for HF), with an increase in health benefit over a patient's lifetime, adding 0.35 QALYs at a cost of £4763, giving an ICER of £13 482 per QALY gained. Findings were robust across tested scenarios.
Catheter-based radiofrequency RDN can be a cost-effective strategy for uncontrolled hypertension in the UK, with an ICER substantially below the NICE cost-effectiveness threshold.
基于导管的射频肾动脉去神经术(RF RDN)最近已在欧洲高血压学会指南和美国食品药品监督管理局获批用于临床。本研究利用当代证据评估了RF RDN的终生成本效益。
基于多变量风险方程的决策分析模型预测了临床事件、质量调整生命年(QALY)和成本。该模型包括七种健康状态:单纯高血压、心肌梗死(MI)、其他有症状冠状动脉疾病、中风、心力衰竭(HF)、终末期肾病和死亡。基于已发表的高血压试验的meta回归估计与诊室收缩压(oSBP)变化相关的风险降低情况。oSBP降低4.9 mmHg的基础病例效应量(观察组与假手术对照组对比)取自337例患者的SPYRAL HTN-ON MED试验。成本基于英国国家医疗服务体系的数据。根据英国国家卫生与临床优化研究所(NICE)每获得一个QALY 20000 - 30000英镑的成本效益阈值评估增量成本效益比(ICER)。进行了广泛的情景分析和敏感性分析,包括三种药物治疗的ON-MED亚组和合并效应量。RF RDN导致10年内临床事件相对风险降低(中风为0.80,MI为0.88,HF为0.72),患者终生健康效益增加,增加0.35个QALY,成本为4763英镑,ICER为每获得一个QALY 13482英镑。在所有测试情景中结果都很稳健。
在英国,基于导管的射频肾动脉去神经术对于难治性高血压可能是一种具有成本效益的策略,其ICER大幅低于NICE成本效益阈值。