Aims 

In patients aged at least 80 years, atrial fibrillation is responsible for significant morbidity and mortality, with a high incidence of stroke. Four new direct oral anticoagulants (DOACs) have been introduced in Italy for the prevention of thromboembolism. Their safety and efficacy in the elderly have already been confirmed. Frailty is frequently associated with aging, but only a few studies have paid attention to interactions between frailty and anticoagulation therapy.

Methods 

We retrospectively evaluated the effectiveness and safety of DOACs in a population aged at least 80 years. Frailty was appraised using an adaptation of the Reported Edmonton Frail Scale, considering a value at least 8 (on a scale from 0 to 18).

Results 

The majority (644/731) of patients remained on DOACs for more than 1 year. A total of 19 patients experienced a thrombotic event while on anticoagulation (1.11 events per 100 person-years) and 26 patients a major bleeding episode (1.52 events per 100 person-years). The probability of interrupting therapy increased significantly with frailty [hazard ratio 2.91 with confidence interval (CI) 2.15–3.92 at univariate analysis, hazard ratio 2.80 with CI 2.03–3.86 at multivariate]; frailty showed a significant impact also on major bleeding (hazard ratio 3.28 with CI 1.45–7.37 at univariate analysis, hazard ratio 3.56 with CI 1.58–8.01 at multivariate).

Conclusion 

Our study highlights how DOACs are a safe and effective option for anticoagulation, even in frail elderly people; the introduction of these drugs is leading to an increased use of anticoagulation therapy in this population. Prospective trials will be needed to reinforce these results and to consider new variables in the thrombotic and hemorrhagic risk scores underlying the prescription of DOACs.

中文翻译：

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80岁以上非瓣膜性心房颤动患者的直接口服抗凝药：体弱的影响

目的 

在至少80岁的患者中，心房纤颤是导致高发病率和高死亡率的重要原因。意大利已经引入了四种新的直接口服抗凝剂（DOAC），以预防血栓栓塞。他们在老年人中的安全性和有效性已经得到证实。衰弱通常与衰老有关，但是只有很少的研究关注衰弱与抗凝治疗之间的相互作用。

方法 

我们回顾性评估了DOAC在至少80岁的人群中的有效性和安全性。使用报告的埃德蒙顿脆弱量表的改编对脆弱性进行评估，考虑值至少为8（从0到18的尺度）。

结果 

大多数（644/731）患者使用DOAC超过1年。共有19例患者在抗凝治疗期间发生了血栓事件（每100人年1.11次事件），有26例患者发生了大出血事件（每100人年1.52次事件）。身体虚弱会中断治疗的可能性显着增加[单因素分析的危险比为2.91，置信区间（CI）为2.15-3.92，多因素的危险比为2.80，CI为2.03-3.86]；体弱对大出血也有显着影响（单因素分析的危险比为3.28，CI为1.45-7.37，多因素分析的危险比为3.56，CI为1.58-8.01）。

结论 

我们的研究突出了DOAC如何成为抗凝的安全有效选择，即使在年老体弱的老年人中也是如此。这些药物的引入导致该人群越来越多地使用抗凝疗法。需要进行前瞻性试验以加强这些结果，并考虑DOAC处方基础上的血栓和出血风险评分的新变量。