Division of Cardiovascular Diseases, Lankenau Heart Institute, Philadelphia, PA, USA.
Boston Scientific, Marlborough, MA, USA.
J Med Econ. 2022 Jan-Dec;25(1):880-887. doi: 10.1080/13696998.2022.2088965.
Antiproliferative therapies based on paclitaxel have been developed to extend the durability of endovascular interventions for lower-extremity atherosclerotic peripheral artery disease, resulting in improved primary vessel patency and fewer target lesion revascularizations. This study evaluated the cost-effectiveness of the sustained-release, paclitaxel-eluting Eluvia stent (Boston Scientific, Marlborough, MA) versus the paclitaxel-coated Zilver PTX stent (Cook Medical, Bloomington, IN) for endovascular intervention in the superficial femoral or proximal popliteal artery.
A microsimulation model was constructed from a United States Medicare perspective with a 24-month time horizon. Patients entering the model were assigned to initial endovascular intervention with either Eluvia or Zilver PTX. Each month patients were exposed to the risks of primary vessel patency loss, target lesion revascularization, amputation, and death. Clinical input parameters were taken from a randomized trial (IMPERIAL) comparing the two interventions at 24-months follow-up. Cost parameters were obtained from analyses of Medicare administrative and claims data. Cost-effectiveness analysis entailed sampling a complete set of clinical and cost parameters from their respective distributions, and then running cohorts of 10,000 patients through each intervention arm of the model. One-way and probabilistic sensitivity analyses were performed.
In the base case microsimulation, at 24 months, the modeled target lesion revascularization was 11.6% for Eluvia and 19.0% for Zilver PTX, and the mean total direct costs were $20,010 and $21,356, respectively (Eluvia average savings=$1,346). In probabilistic sensitivity analyses, Eluvia was cost-effective in 87.8% of all simulations at a willingness-to-pay threshold of $10,000 per target lesion revascularization prevented. Eluvia was more effective and less costly (dominant) than Zilver PTX in 73.6% of simulations.
In this comparison of a paclitaxel-eluting to a paclitaxel-coated stent for endovascular femoropopliteal intervention, Eluvia was more effective and less costly (dominant) than Zilver PTX from a US Medicare perspective. These findings should be considered when formulating reimbursement policy and clinical practice guidelines.
基于紫杉醇的抗增殖疗法已被开发用于延长下肢动脉粥样硬化性外周动脉疾病的血管内介入治疗的持久性，从而提高主血管通畅率并减少靶病变血运重建。本研究评估了在股浅动脉或腘动脉近端进行血管内介入治疗时，使用缓释型紫杉醇洗脱 Eluvia 支架（波士顿科学公司，马萨诸塞州马尔伯勒）与紫杉醇涂层 Zilver PTX 支架（库克医疗公司，印第安纳州布鲁明顿）的成本效益。
从美国医疗保险的角度构建了一个微模拟模型，时间范围为 24 个月。进入模型的患者被分配进行初始血管内介入治疗，使用 Eluvia 或 Zilver PTX。每月患者都会面临主血管通畅丧失、靶病变血运重建、截肢和死亡的风险。临床输入参数取自比较两种干预措施的 24 个月随访的随机试验（IMPERIAL）。成本参数来自对医疗保险行政和理赔数据的分析。成本效益分析涉及从各自的分布中抽取一组完整的临床和成本参数，然后对每个模型干预臂的 10000 名患者进行模拟。进行了单因素和概率敏感性分析。
在基础微模拟中，在 24 个月时，模型化的靶病变血运重建率为 Eluvia 组 11.6%，Zilver PTX 组 19.0%，平均总直接成本分别为 20010 美元和 21356 美元（Eluvia 平均节省 1346 美元）。在概率敏感性分析中，在愿意支付每例靶病变血运重建 10000 美元的阈值下，Eluvia 在所有模拟的 87.8%中具有成本效益。在 73.6%的模拟中，Eluvia 比 Zilver PTX 更有效且成本更低（占优）。
在这项比较用于血管内股浅动脉和腘动脉介入治疗的紫杉醇洗脱支架和紫杉醇涂层支架的研究中，从美国医疗保险的角度来看，Eluvia 比 Zilver PTX 更有效且成本更低（占优）。在制定报销政策和临床实践指南时，应考虑这些发现。
