Department of Cardiology, Shaanxi Provincial People's Hospital, Xi'an, China.
Department of Endocrinology, Shaanxi Provincial People's Hospital, Xi'an, China.
Front Public Health. 2022 Nov 3;10:1016854. doi: 10.3389/fpubh.2022.1016854. eCollection 2022.
In 2019, there were 28. 76 million patients with stroke in China, with ~25% of them suffering from cryptogenic stroke (CS). Patent foramen ovale (PFO) is related to CS, and PFO closure can reduce recurrent stroke. To date, no study has investigated the cost-effectiveness of PFO closure vs. medical therapy among such populations in China.
A Markov model with a cycle length of 3 months was established to compare the 30-year cost-effectiveness of PFO closure and medical therapy. The transition probability of recurrent stroke was derived from the RESPECT study, and the costs and utility were obtained from domestic data or studies conducted in China. The primary outcome of this study was the incremental cost-effectiveness ratio (ICER), which represents the incremental cost per quality-adjusted life year (QALY). PFO closure was considered cost-effective if the ICER obtained was lower than the willingness-to-pay (WTP) threshold of 37,654 USD/QALY; otherwise, PFO closure was regarded as not being cost-effective. One-way and probabilistic sensitivity analyses were performed to test the robustness of the results.
After a simulation of a 30-year horizon, a cryptogenic stroke patient with PFO was expected to have QALY of 13.15 (15.26 LY) if he received PFO closure and a corresponding value of 11.74 QALY (15.14 LY) after medical therapy. The corresponding costs in both cohorts are US $8,131 and US $4,186, respectively. Thus, an ICER of 2783 USD/QALY and 31264 USD/LY was obtained, which is lower than the WTP threshold. One-way and probabilistic sensitivity analyses showed that the results were robust.
With respect to the WTP threshold of three times per capita GDP in China in 2021, PFO closure is a cost-effective method for Chinese cryptogenic stroke patients with PFO, as shown in the 30-year simulation.
2019 年，中国有 2876 万脑卒中患者，其中约 25%为隐源性脑卒中（CS）。卵圆孔未闭（PFO）与 CS 相关，PFO 封堵可降低复发性卒中。迄今为止，尚无研究在中国此类人群中比较 PFO 封堵与药物治疗的成本效益。
建立一个周期长度为 3 个月的马尔可夫模型，比较 PFO 封堵与药物治疗 30 年的成本效益。复发性卒中的转移概率来自 RESPECT 研究，成本和效用来自国内数据或在中国进行的研究。本研究的主要结果是增量成本效益比（ICER），表示每增加一个质量调整生命年（QALY）的增量成本。如果获得的 ICER 低于 37654 美元/QALY 的意愿支付（WTP）阈值，则认为 PFO 封堵具有成本效益；否则，认为 PFO 封堵不具有成本效益。进行了单因素和概率敏感性分析，以检验结果的稳健性。
经过 30 年的模拟，接受 PFO 封堵的 PFO 伴隐源性卒中患者预计将获得 13.15（15.26 LY）的 QALY，而接受药物治疗的患者则获得 11.74 QALY（15.14 LY）。两组的相应成本分别为 8131 美元和 4186 美元。因此，获得了 2783 美元/QALY 和 31264 美元/LY 的 ICER，低于 WTP 阈值。单因素和概率敏感性分析表明结果稳健。
根据 2021 年中国人均 GDP 的三倍意愿支付阈值，PFO 封堵是中国 PFO 伴隐源性卒中患者的一种具有成本效益的方法，30 年模拟结果显示如此。
