Winstén Aleksi K, Langén Ville, Airaksinen K E Juhani, Teppo Konsta
Department of Mathematics and Statistics, University of Turku, Turku, Finland.
Faculty of Medicine, University of Turku, Turku, Finland.
JAMA Netw Open. 2025 May 1;8(5):e258461. doi: 10.1001/jamanetworkopen.2025.8461.
The role of anticoagulation for stroke prevention in patients with device-detected atrial high-rate episodes, also known as subclinical atrial fibrillation (AF), is a subject of equipoise.
To assess the net benefit of nonvitamin K antagonist oral anticoagulants (NOACs) in patients with device-detected subclinical AF.
DESIGN, SETTING, AND PARTICIPANTS: Decision analytical model run with 10 000 patients with anticoagulation and 10 000 patients without anticoagulation in a clinical scenario of deciding whether to start NOACs for stroke prevention in patients with subclinical AF. A Markov decision model was conducted on October 1, 2024, to estimate net outcomes of NOACs. The patients had stroke risk and bleeding risks similar to those of patients in randomized trials of anticoagulation in subclinical AF.
Anticoagulation was modeled to decrease the risk of ischemic stroke by 32% and increase the risk of major bleeding by 62%. In probabilistic sensitivity analyses, the 95% CIs for treatment effect sizes were also considered.
The main outcome measure for overall net benefit was the cumulative quality-adjusted life-years (QALYs) during the simulation. The model considered the number and severity of ischemic strokes, hemorrhagic strokes, other intracranial bleeds, and extracranial bleeds, as well as the number of deaths during a 10-year simulation.
When comparing the 2 cohorts of 10 000 patients (mean age, 77 years; 3700 [37%] women), those receiving NOAC therapy had 233 fewer ischemic strokes (21.7%), 55 fewer deaths (1.1%), and 453 more major bleeding events (37.3%) over a 10-year simulation period. Per patient, these differences translated to approximately 1 additional quality-adjusted week of life (0.024 QALYs) with NOAC treatment during the 10-year simulation. When the 95% CIs of treatment effect sizes were considered in probabilistic sensitivity analysis, there was a 65.8% probability that NOAC treatment leads to more QALYs than withholding treatment.
In this analytical model study, initiating NOACs in patients with device-detected subclinical AF was associated with a minimal increase in QALYs. However, the benefits were uncertain, and the effect size of the overall net benefit does not appear to be clinically meaningful.
对于设备检测到心房高率发作（也称为亚临床房颤（AF））的患者，抗凝在预防卒中方面的作用尚无定论。
评估非维生素K拮抗剂口服抗凝剂（NOACs）在设备检测到的亚临床房颤患者中的净获益。
设计、设置和参与者：在一个决定是否开始使用NOACs预防亚临床房颤患者卒中的临床场景中，对10000例接受抗凝治疗的患者和10000例未接受抗凝治疗的患者进行决策分析模型。于2024年10月1日进行马尔可夫决策模型，以估计NOACs的净结局。这些患者的卒中风险和出血风险与亚临床房颤抗凝随机试验中的患者相似。
抗凝治疗被模拟为使缺血性卒中风险降低32%，使大出血风险增加62%。在概率敏感性分析中，还考虑了治疗效应大小的95%置信区间。
总体净获益的主要结局指标是模拟期间的累积质量调整生命年（QALYs）。该模型考虑了缺血性卒中、出血性卒中、其他颅内出血和颅外出血的数量和严重程度，以及10年模拟期间的死亡人数。
在比较两组各10000例患者（平均年龄77岁；3700例[37%]为女性）时，在10年模拟期内，接受NOAC治疗的患者缺血性卒中减少233例（21.7%），死亡减少55例（1.1%），大出血事件增加453例（37.3%）。每位患者而言，这些差异转化为在10年模拟期间接受NOAC治疗时大约多1个质量调整生命周（0.024 QALYs）。在概率敏感性分析中考虑治疗效应大小的95%置信区间时，NOAC治疗比不治疗导致更多QALYs的概率为65.8%。
在这项分析模型研究中，对设备检测到的亚临床房颤患者启动NOACs与QALYs的最小增加相关。然而，获益并不确定，总体净获益的效应大小似乎没有临床意义。
