Claassens Daniel M F, van Dorst Pim W M, Vos Gerrit J A, Bergmeijer Thomas O, Hermanides Renicus S, van 't Hof Arnoud W J, van der Harst Pim, Barbato Emanuele, Morisco Carmine, Tjon Joe Gin Richard M, Asselbergs Folkert W, Mosterd Arend, Herrman Jean-Paul R, Dewilde Willem J M, Postma Maarten J, Deneer Vera H M, Ten Berg Jurriën M, Boersma Cornelis
Department of Cardiology, St. Antonius Hospital, Koekoekslaan 1, 3435CM, Nieuwegein, The Netherlands.
Department of Cardiology, Isala Hospital, Zwolle, The Netherlands.
Am J Cardiovasc Drugs. 2022 Mar;22(2):195-206. doi: 10.1007/s40256-021-00496-4. Epub 2021 Sep 7.
The POPular Genetics trial demonstrated that a CYP2C19 genotype-guided P2Y inhibitor strategy reduced bleeding rates compared with standard treatment with ticagrelor or prasugrel without increasing thrombotic event rates after primary percutaneous coronary intervention (PCI).
In this analysis, we aimed to evaluate the cost effectiveness of a genotype-guided strategy compared with standard treatment with ticagrelor or prasugrel.
A 1-year decision tree based on the POPular Genetics trial in combination with a lifelong Markov model was developed to compare costs and quality-adjusted life-years (QALYs) between a genotype-guided and a standard P2Y inhibitor strategy in patients with myocardial infarction undergoing primary PCI. The cost-effectiveness analysis was conducted from a Dutch healthcare system perspective. Within-trial survival and utility data were combined with lifetime projections to evaluate lifetime cost effectiveness for a cohort of 1000 patients. Costs and utilities were discounted at 4 and 1.5%, respectively, according to Dutch guidelines for health economic studies. Besides deterministic and probabilistic sensitivity analyses, several scenario analyses were also conducted (different time horizons, different discount rates, equal prices for P2Y inhibitors, and equal distribution of thrombotic events between the two strategies).
Base-case analysis with a hypothetical cohort of 1000 subjects demonstrated 8.98 QALYs gained and €725,550.69 in cost savings for the genotype-guided strategy (dominant). The deterministic and probabilistic sensitivity analysis confirmed the robustness of the model and the cost-effectiveness results. In scenario analyses, the genotype-guided strategy remained dominant.
In patients undergoing primary PCI, a CYP2C19 genotype-guided strategy compared with standard treatment with ticagrelor or prasugrel resulted in QALYs gained and cost savings.
Clinicaltrials.gov number: NCT01761786, Netherlands trial register number: NL2872.
“POPular Genetics”试验表明，与替格瑞洛或普拉格雷标准治疗相比，经细胞色素P450 2C19（CYP2C19）基因型指导的P2Y抑制剂策略可降低出血率，且在直接经皮冠状动脉介入治疗（PCI）后不会增加血栓形成事件发生率。
在本分析中，我们旨在评估基因型指导策略与替格瑞洛或普拉格雷标准治疗相比的成本效益。
基于“POPular Genetics”试验构建了一个1年决策树，并结合终身马尔可夫模型，以比较接受直接PCI的心肌梗死患者中基因型指导的P2Y抑制剂策略与标准策略之间的成本和质量调整生命年（QALY）。成本效益分析是从荷兰医疗保健系统的角度进行的。试验内生存和效用数据与终身预测相结合，以评估1000名患者队列的终身成本效益。根据荷兰卫生经济研究指南，成本和效用分别按4%和1.5%进行贴现。除了确定性和概率敏感性分析外，还进行了几种情景分析（不同的时间范围、不同的贴现率、P2Y抑制剂价格相同以及两种策略之间血栓形成事件分布相等）。
对1000名受试者的假设队列进行的基础案例分析表明，基因型指导策略获得了8.98个QALY，成本节约725,550.69欧元（占主导地位）。确定性和概率敏感性分析证实了模型和成本效益结果的稳健性。在情景分析中，基因型指导策略仍然占主导地位。
在接受直接PCI的患者中，与替格瑞洛或普拉格雷标准治疗相比，CYP2C19基因型指导策略可带来QALY增加和成本节约。
Clinicaltrials.gov编号：NCT01761786，荷兰试验注册号：NL2872。
