Supplementary material: Polymer-based drug-eluting stent treatment extends the time to reintervention for patients with symptomatic femoropopliteal artery disease: clinical evidence and potential economic value

These are peer-reviewed supplementary materials for the article 'Polymer-based drug-eluting stent treatment extends the time to reintervention for patients with symptomatic femoropopliteal artery disease: clinical evidence and potential economic value' published in the Journal of Comparative Effectiveness Research.Supplementary Table 1: Cost savings model input parametersSupplementary Figure 1: Estimation of the cost associated with second femoropopliteal artery interventionSupplementary Table 2: Codes used to identify revascularization procedures in Medicare data for the cost modelSupplementary Figure 2: Kaplan-Meier analysis of primary patency in IMPERIAL through 5 years, with standard errorsAim: Use long-term follow-up data from the IMPERIAL study to determine whether drug-eluting polymer based nitinol stent treatment can delay the time to repeat intervention for femoropopliteal artery disease and how such a delay may result in cost savings in a value-based episode of care. Patients & methods: The IMPERIAL randomized controlled trial was an international study of a paclitaxel-eluting polymer coated stent (Eluvia, Boston Scientific, MA, USA) versus a polymer-free paclitaxel-coated stent (Zilver PTX, Cook Corporation, IN, USA) for treating lesions of the femoropopliteal arterial segment. Study patients (n = 465) had symptomatic lower limb ischemia. Safety and efficacy assessments were performed through 5 years. Mean time to first reintervention was calculated in post-hoc analysis for patients who underwent a clinically driven target lesion revascularization (CD-TLR) through 3 or 5 years following the index procedure. To simulate potential cost savings associated with differential CD-TLR burden over time, a cost-avoidance analysis using input parameters from IMPERIAL and US 100% Medicare standard analytical files was developed. Results: Among patients with a first CD-TLR through 3 years of follow-up, mean time to reintervention was 5.5 months longer (difference 166 days, 95% CI: 51, 282 days; p = 0.0058) for patients treated with Eluvia (n = 56) than for those treated with Zilver PTX (n = 30). Through the 5-year study follow up period, CD-TLR rates were 29.3% (68/232) for Eluvia and 34.2% (39/114) for Zilver PTX (p = 0.3540) and mean time to first reintervention exceeded 2 years for patients treated with Eluvia at 737 days versus 645 days for the Zilver PTX group (difference 92 days, 95% CI: -85, 269 days; p = 0.3099). Simulated savings considering reinterventions occurring over 1 and 5 years following initial use of Eluvia over Zilver PTX were US $1,395,635 and US $1,531,795, respectively, when IMPERIAL CD-TLR rates were extrapolated to 1000 patients. Conclusion: IMPERIAL data suggest initial treatment with Eluvia extends the time patients spend without undergoing reintervention. This extension may be associated with cost savings in relevant time frames.

本数据集为发表于《比较有效性研究杂志》上的文章《基于聚合物的药物释放支架治疗可延长患有症状性股浅动脉疾病患者的再干预时间：临床证据及潜在的经济价值》的同行评审补充材料。补充表1：成本节约模型输入参数；补充图1：第二次股浅动脉干预相关的成本估算；补充表2：用于识别医疗保险数据中再血管化手术的代码；补充图2：IMPERIAL研究5年内主要通畅率的Kaplan-Meier分析，附带标准误差。研究目的：利用IMPERIAL研究的长期随访数据，确定基于药物释放聚合物的镍钛合金支架治疗是否能够推迟股浅动脉疾病患者的重复干预时间，以及这种延迟如何可能导致基于价值的护理时段内的成本节约。研究对象与方法：IMPERIAL随机对照试验是一项国际研究，比较了帕克替诺尔药物释放聚合物涂层支架（Eluvia，波士顿科学公司，马萨诸塞州，美国）与无聚合物帕克替诺尔涂层支架（Zilver PTX，库克公司，印第安纳州，美国）在治疗股浅动脉节段病变中的效果。研究患者（n = 465）患有症状性下肢缺血。安全性及有效性评估持续至5年。通过回顾性分析，计算了在临床驱动的目标病变再血管化（CD-TLR）术后3年或5年内的患者的平均再干预时间。为了模拟与时间相关的不同CD-TLR负担可能带来的潜在成本节约，利用IMPERIAL和美国家庭医疗保险100%标准分析文件中的输入参数，开发了一种成本避免分析。研究结果：在随访3年内首次发生CD-TLR的患者中，接受Eluvia治疗的患者（n = 56）的平均再干预时间比接受Zilver PTX治疗的患者（n = 30）长5.5个月（差异166天，95%置信区间：51至282天；p = 0.0058）。在5年的研究随访期内，Eluvia组的CD-TLR率为29.3%（68/232），Zilver PTX组的CD-TLR率为34.2%（39/114）（p = 0.3540），接受Eluvia治疗的患者首次再干预的平均时间超过2年，为737天，而Zilver PTX组为645天（差异92天，95%置信区间：-85至269天；p = 0.3099）。当将IMPERIAL的CD-TLR率外推至1000名患者时，模拟的节约成本分别为Eluvia相较于Zilver PTX在初始使用后1年和5年内的1,395,635美元和1,531,795美元。研究结论：IMPERIAL数据显示，Eluvia的初始治疗可以延长患者免于重复干预的时间。这种延长可能与相关时间段内的成本节约相关。