Ann Fam Med. 2020 Mar;18(2):131-138. doi: 10.1370/afm.2495.
Most real-world studies on anticoagulants have been based on health insurance databases or performed in secondary care. The aim of this study was to compare safety and effectiveness between patients treated with vitamin K antagonists (VKAs) and patients treated with direct oral anticoagulants (DOACs) in a general practice setting.
The CACAO study (Comparison of Accidents and their Circumstances with Oral Anticoagulants) is a multicenter prospective cohort study conducted among ambulatory patients taking an oral anticoagulant. Participants were patients from the study's cross-sectional phase receiving oral anticoagulants because of nonvalvular atrial fibrillation, for secondary prevention of venous thromboembolism, or both. They were followed as usual for 1 year by their general practitioners, who collected data on changes in therapy, thromboembolic events, bleeding, and deaths. All events were adjudicated by an independent committee. We used a propensity score and a Cox regression model to derive hazard ratios.
Between April and December 2014, a total of 3,082 patients were included. At 1 year, 42 patients (1.7%) had experienced an arterial or venous event; 151 (6.1%) had experienced bleeding, including 47 (1.9%) who experienced major bleeding; and 105 (4.1%) had died. There was no significant difference between the VKA and DOAC groups regarding arterial or venous events, or major bleeding. The VKA group had a lower risk of overall bleeding (hazard ratio = 0.65; 95% CI, 0.43-0.98) but twice the risk of death (hazard ratio = 1.98; 95% CI, 1.15-3.42).
VKAs and DOACs had fairly similar safety and effectiveness in general practice. The substantially higher incidence of deaths with VKAs is consistent with known data from health insurance databases and calls for further research to understand its cause.
大多数关于抗凝剂的真实世界研究都是基于医疗保险数据库或在二级医疗机构进行的。本研究旨在比较维生素 K 拮抗剂（VKA）和直接口服抗凝剂（DOAC）治疗的患者在一般实践环境中的安全性和有效性。
CACAO 研究（口服抗凝剂相关意外事件及其情况比较）是一项多中心前瞻性队列研究，在接受口服抗凝剂治疗的门诊患者中进行。参与者是横断面研究阶段接受口服抗凝剂治疗的患者，原因是非瓣膜性心房颤动、静脉血栓栓塞症的二级预防或两者兼有。他们由他们的家庭医生按常规继续随访 1 年，家庭医生收集治疗方案改变、血栓栓塞事件、出血和死亡的数据。所有事件均由独立委员会进行裁决。我们使用倾向评分和 Cox 回归模型得出风险比。
2014 年 4 月至 12 月期间，共纳入 3082 例患者。1 年后，42 例（1.7%）发生动脉或静脉事件；151 例（6.1%）发生出血，其中 47 例（1.9%）发生大出血；105 例（4.1%）死亡。VKA 和 DOAC 组之间在动脉或静脉事件或大出血方面无显著差异。VKA 组总体出血风险较低（风险比=0.65；95%CI，0.43-0.98），但死亡风险高两倍（风险比=1.98；95%CI，1.15-3.42）。
VKA 和 DOAC 在一般实践中具有相当相似的安全性和有效性。VKA 组死亡率显著升高，与医疗保险数据库的已知数据一致，需要进一步研究以了解其原因。
