Pietzsch Jan B, Geisler Benjamin P, Iken Annabelle R, van Wijck Iris P S, Holewijn Suzanne, Reijnen Michel M P J
Wing Tech Inc., Menlo Park, CA, USA.
Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Cardiovasc Intervent Radiol. 2022 Mar;45(3):298-305. doi: 10.1007/s00270-021-03050-6. Epub 2022 Jan 4.
Drug-coated balloons (DCBs) for femoropopliteal peripheral artery disease have been shown to be clinically superior and cost-effective compared to conventional percutaneous transluminal angioplasty (PTA). However, few studies enrolled patients with chronic limb-threatening ischemia (CLTI). Our objective was to study the cost-effectiveness of endovascular treatment with versus without DCB in CLTI patient populations in the Netherlands and Germany.
Target lesion revascularization (TLR) and major amputation rates were obtained from the CLTI subgroup of the IN.PACT Global study. Rates for "status quo" treatment involving PTA with primary or bailout stenting were derived from systematic literature search. Costs and cost-effectiveness were calculated using a decision-analytic Markov model considering, in the base case, a 2-year horizon, and strategy-specific quality-adjusted life year (QALY) gains calculated from survival and health state-specific utilities. A willingness-to-pay threshold of €50,000/QALY was assumed, and extensive sensitivity analyses were performed.
Model-projected 24-month probabilities of TLR were 26.2% and 32.8% for treatment with and without DCB, and probabilities for amputation were 2.8% and 11.9%, respectively. DCB added 0.017 QALYs while saving €1,030 in the Dutch setting and €513 in the German setting, respectively. DCB was found dominant or cost-effective across a wide range of assumptions.
Urea excipient drug-coated balloon therapy for treating CLTI from femoropopliteal artery disease is associated with improved patient outcomes and expected overall cost savings to payers in the Dutch and German healthcare systems, rendering it a cost-effective and likely dominant treatment strategy.
与传统经皮腔内血管成形术（PTA）相比，用于股腘动脉外周动脉疾病的药物涂层球囊（DCB）已显示出临床优势且具有成本效益。然而，很少有研究纳入慢性肢体威胁性缺血（CLTI）患者。我们的目标是研究在荷兰和德国的CLTI患者群体中，使用DCB与不使用DCB进行血管内治疗的成本效益。
从IN.PACT Global研究的CLTI亚组中获取靶病变血管重建（TLR）和大截肢率。涉及PTA联合初次或补救性支架置入的“现状”治疗率来自系统文献检索。使用决策分析马尔可夫模型计算成本和成本效益，在基础案例中，考虑2年的时间范围，并根据生存情况和特定健康状态效用计算特定策略的质量调整生命年（QALY）增益。假设支付意愿阈值为50,000欧元/QALY，并进行了广泛的敏感性分析。
模型预测，使用DCB和不使用DCB治疗的24个月TLR概率分别为26.2%和32.8%，截肢概率分别为2.8%和11.9%。在荷兰的情况下，DCB增加了0.017个QALY，同时节省了1030欧元，在德国的情况下节省了513欧元。在广泛的假设范围内，DCB被发现具有主导性或成本效益。
用于治疗股腘动脉疾病导致的CLTI的尿素辅料药物涂层球囊疗法与改善患者预后相关，并有望为荷兰和德国医疗系统的支付方节省总体成本，使其成为一种具有成本效益且可能具有主导性的治疗策略。
