Rodríguez-Leor Oriol, Ryschon Anne M, Cao Khoa N, Jaén-Águila Fernando, García-Camarero Tamara, Mansilla-Morales Carlos, Kolovetsios Michael, Álvarez-Orozco María, García-Donaire José Antonio, Pietzsch Jan B
Institut del Cor (ICOR), Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, España Institut del Cor (ICOR) Hospital Universitari Germans Trias i Pujol Barcelona España.
Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Instituto de Salud Carlos III, Madrid, España Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV) Instituto de Salud Carlos III Madrid España.
REC Interv Cardiol. 2024 Oct 30;6(4):305-312. doi: 10.24875/RECIC.M24000478. eCollection 2024 Oct-Dec.
Radiofrequency (RF) renal denervation (RDN) has been shown to be a safe and effective treatment option for patients with uncontrolled hypertension. This analysis sought to explore the cost-effectiveness of this therapy in Spain.
A decision-analytic Markov model projected clinical events, quality-adjusted life years (QALY) and costs over the patients' lifetime. Treatment effectiveness in the base case analysis was informed by the change in office systolic blood pressure observed in the full cohort of the SPYRAL HTN-ON MED trial (-4.9 mmHg vs sham control). Alternate scenarios were calculated for effect sizes reported in the HTN-ON MED subcohort of patients on 3 antihypertensive medications treated outside the United States, the HTN-OFF MED trial, and the Global SYMPLICITY Registry high-risk and very high-risk cohorts. The analysis was conducted from the Spanish National Health System perspective and a willingness-to-pay a threshold of 25000 per QALY gained was considered.
RF RDN therapy resulted in clinical event reductions (10-year relative risk 0.80 for stroke, 0.88 for myocardial infarction, and 0.72 for heart failure) and a lifetime gain of 0.35 (13.99 vs 13.63) QALYs. Incremental lifetime costs were 5335 (26 381 vs 21 045), resulting in an incremental cost-effectiveness ratio of 15 057 per QALY gained. Cost-effectiveness was further improved among all the other clinical evidence scenarios.
The results of this study suggest that RF RDN can provide a cost-effective alternative in the treatment of uncontrolled hypertension in Spain.
射频（RF）肾去神经术（RDN）已被证明是治疗难治性高血压患者的一种安全有效的治疗选择。本分析旨在探讨该疗法在西班牙的成本效益。
采用决策分析马尔可夫模型预测患者一生中的临床事件、质量调整生命年（QALY）和成本。基础病例分析中的治疗效果依据SPYRAL HTN-ON MED试验全队列中观察到的诊室收缩压变化（-4.9 mmHg，与假手术对照组相比）。针对在美国境外接受3种抗高血压药物治疗的HTN-ON MED亚组患者、HTN-OFF MED试验以及全球SYMPLICITY注册研究的高危和极高危队列中报告的效应大小，计算了替代方案。分析是从西班牙国家卫生系统的角度进行的，并考虑了每获得一个QALY愿意支付25000的阈值。
RF RDN疗法使临床事件减少（中风的10年相对风险为0.80，心肌梗死为0.88，心力衰竭为0.72），一生可获得0.35（13.99对13.63）个QALY。终生增量成本为5335（26381对21045），导致每获得一个QALY的增量成本效益比为15057。在所有其他临床证据情景中，成本效益进一步提高。
本研究结果表明，RF RDN在西班牙治疗难治性高血压方面可提供一种具有成本效益的替代方案。
