Fanning Laura, Ilomäki Jenni, Bell J Simon, Dārziņš Pēteris
Eastern Health Clinical School, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.
Geriatric Medicine, Eastern Health, Melbourne, Australia.
Eur J Clin Pharmacol. 2017 Nov;73(11):1427-1436. doi: 10.1007/s00228-017-2297-0. Epub 2017 Jul 27.
Trials of the direct oral anticoagulants (DOACs) dabigatran, rivaroxaban and apixaban provide the basis for prescribing for the prevention of stroke and systemic embolism in atrial fibrillation (AF). The objective of this study was to assess the representativeness of the three pivotal DOAC randomized controlled trials of dabigatran, rivaroxaban and apixaban for unselected hospitalized patients with AF.
A cross-sectional study was undertaken. All patients discharged with AF between 2012 and 2015 from a large public hospital network in Melbourne, Australia, were identified. Inclusion and exclusion criteria from the DOAC trials were applied. The proportions of hospitalized patients with AF who would have been eligible for the dabigatran (RE-LY), rivaroxaban (ROCKET-AF) and apixaban (ARISTOTLE) trials were estimated, as was pooled eligibility for all three trials. Characteristics of eligible and ineligible patients were compared.
For the 4734 patients, application of the inclusion and exclusion criteria resulted in 60.5, 52.6 and 35.8% eligibility for the trials of apixaban, dabigatran and rivaroxaban, respectively. Pooled eligibility across all three trials demonstrated that 33.4% of the patients would have been eligible for all three trials but 36.7% ineligible for any trial. Ineligible patients who met exclusion criteria were older and experienced more comorbidities.
The apixaban and dabigatran trials may be the most representative of hospitalized patients with AF. The DOAC trial results can readily be extrapolated to, and guide prescribing for, at least two thirds of patients discharged from a large metropolitan health service in Australia.
直接口服抗凝剂（DOACs）达比加群、利伐沙班和阿哌沙班的试验为房颤（AF）患者预防中风和全身性栓塞的处方提供了依据。本研究的目的是评估达比加群、利伐沙班和阿哌沙班三项关键DOAC随机对照试验对未选择的住院房颤患者的代表性。
进行了一项横断面研究。确定了2012年至2015年间从澳大利亚墨尔本一个大型公立医院网络出院的所有房颤患者。应用了DOAC试验的纳入和排除标准。估计了符合达比加群（RE-LY）、利伐沙班（ROCKET-AF）和阿哌沙班（ARISTOTLE）试验条件的住院房颤患者比例，以及所有三项试验的综合符合率。比较了符合条件和不符合条件患者的特征。
对于4734例患者，应用纳入和排除标准后，阿哌沙班、达比加群和利伐沙班试验的符合率分别为60.5%、52.6%和35.8%。所有三项试验的综合符合率表明，33.4%的患者符合所有三项试验的条件，但36.7%的患者不符合任何一项试验的条件。符合排除标准的不符合条件患者年龄较大，合并症较多。
阿哌沙班和达比加群试验可能最能代表住院房颤患者。DOAC试验结果可以很容易地外推至澳大利亚一个大型都市医疗服务机构出院的至少三分之二的患者，并指导他们的处方用药。
