Department of Internal Medicine, University Hospitals of Geneva, Geneva, Switzerland; Department of Epidemiology, School of Public Health, University of Washington, Seattle.
Division of Angiology and Hemostasis, Department of Internal Medicine, University Hospitals of Geneva, Geneva, Switzerland.
Chest. 2012 Feb;141(2):321-329. doi: 10.1378/chest.11-0625. Epub 2011 Jul 14.
According to the Comparison of Arixtra in Lower Limb Superficial Vein Thrombosis with Placebo (CALISTO) study, a recent randomized, controlled trial, prophylactic fondaparinux can prevent thrombotic complications following superficial vein thrombosis (SVT). The cost-effectiveness of this treatment remains to be determined.
We developed a decision-tree model comparing fondaparinux 2.5 mg daily for 45 days vs no treatment of SVT. It included all clinical events associated with SVT, its treatment, its complications, and all respective quality-adjustment factors. Data were mainly derived from the CALISTO study and the published literature. Measured outcomes comprised clinical events (VTE, major hemorrhage, death), quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness ratios (ICERs). The analysis was conducted using a lifetime time horizon from a health-care system perspective. We performed one-way and probabilistic sensitivity analyses to evaluate parameter uncertainty.
In 10,000 patients, we estimated that fondaparinux would prevent 123 VTE events and two deaths. On a per-patient basis, the incremental QALY compared with no treatment was 0.04 (1 day) at an incremental cost of $1,734, resulting in an ICER of $500,000 per QALY. This result remained robust in the one-way sensitivity analyses, with an ICER remaining > $100,000 per QALY throughout all ranges. Based on probabilistic sensitivity analyses, the probability that fondaparinux was cost-effective was 1% at a willingness-to-pay of $100,000 per QALY.
Fondaparinux for 45 days does not appear to be cost-effective when treating patients with isolated SVT of the legs. A better value for money could be obtained in subgroups of patients with a higher incidence of VTE after SVT. Shorter durations of treatment should be further evaluated in future clinical studies.
根据最近一项随机对照试验——《阿利西尤单抗在下肢浅静脉血栓形成中的疗效与安慰剂对照（CALISTO）研究》，预防性使用磺达肝癸钠可预防浅静脉血栓形成（SVT）后的血栓并发症。但这种治疗方法的成本效益仍有待确定。
我们建立了一个决策树模型，比较了每日使用磺达肝癸钠 2.5mg 持续 45 天与不治疗 SVT 的情况。该模型纳入了所有与 SVT 相关的临床事件、SVT 的治疗及其并发症，以及各自的质量调整因素。数据主要来源于 CALISTO 研究和已发表的文献。测量结果包括临床事件（VTE、大出血、死亡）、质量调整生命年（QALYs）、成本和增量成本效益比（ICER）。分析采用了从医疗保健系统角度来看的终生时间范围。我们进行了单因素和概率敏感性分析，以评估参数的不确定性。
在 10000 名患者中，我们估计磺达肝癸钠将预防 123 例 VTE 事件和 2 例死亡。与不治疗相比，每位患者的增量 QALY 为 0.04（1 天），增量成本为 1734 美元，增量成本效益比为 500000 美元/QALY。在单因素敏感性分析中，这一结果仍然稳健，在所有范围内，增量成本效益比均超过 100000 美元/QALY。基于概率敏感性分析，在支付意愿为 100000 美元/QALY 时，磺达肝癸钠具有成本效益的概率为 1%。
对于单独患有腿部 SVT 的患者，磺达肝癸钠治疗 45 天似乎并不具有成本效益。在 SVT 后 VTE 发生率较高的患者亚组中，可能会获得更高的性价比。未来的临床研究应进一步评估更短的治疗持续时间。
