Chair of Health Systems, ESSEC Business School, Cergy-Pontoise, Paris, France.
Cerebrovasc Dis. 2013;35(4):320-6. doi: 10.1159/000347074. Epub 2013 Apr 23.
Atrial fibrillation (AF) is the main direct cause of stroke. Prevention by anticoagulation or antithrombotic treatment is required, vitamin K antagonists (VKAs) and aspirin being the main agents. Dabigatran etexilate is a novel oral direct thrombin inhibitor. The RE-LY study demonstrated that in patients with AF, the rates of stroke and systemic embolism were similar (at a dose of 110 mg) or lower (at a dose of 150 mg) than those observed in patients treated with warfarin, a VKA. The aim of the present study was to estimate, through modeling, the number of severe events avoided with dabigatran at dosages of 110 mg (D110) or 150 mg (D150) twice daily compared to warfarin, when prescribed in the French population for patients with AF who meet the inclusion criteria of the Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY) study.
We used a decision tree type model to simulate the outcome at 5 years in a cohort of patients eligible for treatment with dabigatran. We compared 3 hypothetical cohorts: all AF patients are treated with D110, D150 and warfarin. Based on the probabilities of occurrence of the different outcomes observed in the RE-LY study and in the Dijon Stroke Registry, we simulated for each year during 5 years the evolution of the 3 cohorts. The model allows to simulate a prevalent cohort of 461,392 patients at year zero, with a follow-up of 5 years ('constant prevalence model'), and it can also take into account incident patients during 5 years ('dynamic prevalence model'). The different events taken into account were: major hemorrhages (excluding hemorrhagic strokes), myocardial infarctions, hemorrhagic strokes, ischemic strokes, recurrence of strokes (without differentiating the mechanism) or deaths.
Considering the constant prevalence model, the use of D110 instead of warfarin for the whole target population in France would permit to avoid 10,012 events and to save 18,879 years of life in a period of 5 years. These figures are 13,484 and 27,736 for D150 instead of warfarin. Considering the dynamic prevalence model, the use of D110 for the whole target population in France would permit to avoid 13,620 events and to save 22,674 years of life in a period of 5 years. These figures are 18,186 and 33,091 for D150.
The use of dabigatran would lead to a significant reduction of strokes and deaths attributable to AF in France.
心房颤动（AF）是中风的主要直接原因。需要通过抗凝或抗血栓治疗进行预防，维生素 K 拮抗剂（VKAs）和阿司匹林是主要药物。达比加群酯是一种新型的口服直接凝血酶抑制剂。RE-LY 研究表明，在 AF 患者中，华法林（一种 VKA）治疗组的中风和全身性栓塞发生率与达比加群酯 110mg 剂量组相似（110mg 剂量）或更低（150mg 剂量）。本研究的目的是通过建模估计，在符合 RE-LY 研究纳入标准的 AF 患者中，与华法林相比，达比加群酯 110mg（D110）或 150mg（D150）每日两次给药可避免多少严重事件。
我们使用决策树类型的模型来模拟符合条件的患者在 5 年内的结局。我们比较了 3 个假设队列：所有 AF 患者均接受 D110、D150 和华法林治疗。根据 RE-LY 研究和第戎卒中登记处观察到的不同结局的发生概率，我们在 5 年内模拟了每个队列的演变。该模型允许模拟一个 461,392 名患者的流行队列，随访 5 年（“固定流行率模型”），并且还可以考虑 5 年内的新发患者。考虑到固定流行率模型，在法国，将 D110 用于整个目标人群而非华法林，将在 5 年内避免 10,012 例事件并节省 18,879 年的生命。这些数字分别为 D150 而非华法林的 13,484 和 27,736。对于动态流行率模型，在法国，将 D110 用于整个目标人群将在 5 年内避免 13,620 例事件并节省 22,674 年的生命。这些数字分别为 D150 而非华法林的 18,186 和 33,091。
在法国，达比加群酯的使用将显著降低与 AF 相关的中风和死亡。
