Fondazione Umbra Cuore e Ipertensione-ONLUS, Hospital S. Maria della Misericordia, Cardiology, Perugia.
Cardiology Department, Ospedale Monaldi, Naples.
J Cardiovasc Med (Hagerstown). 2019 Feb;20(2):66-73. doi: 10.2459/JCM.0000000000000744.
Real-world data on treatment persistence, safety and effectiveness of non-Vitamin K antagonist oral anticoagulants (NOACs) play an important role in the assessment of risks and benefits of these drugs. Our aim was to evaluate persistence on treatment, incidence of major bleeding and incidence of a composite endpoint of major events, including all-cause death, myocardial infarction, stroke and systemic thromboembolism, during treatment with apixaban in a cohort of patients with nonvalvular atrial fibrillation (NVAF).
In this multicentre retrospective observational study, we retrieved data from medical records of five Italian hospitals on patients with a diagnosis of NVAF who initiated apixaban between 1 January 2014 and 31 March 2016 and had a first subsequent visit at the same hospital.
We studied 766 patients with mean age of 74.2 (standard deviation 11.1) years and median CHADS2 and CHA2DS2VASc scores of 2.0 and 4.0, respectively. Over a median follow-up period of 339 days, persistence on treatment was 83.5% [95% confidence interval (95% CI) 75.5-89.1%]. The rate of major bleeding (per 100 person-years) was 1.15 (95% CI 0.39-1.90 per 100 person-years), while the cumulative incidence was 4.4% (95% CI 1.6-12.0). The rate of major events was 1.97 (95% CI 1.08-2.86) per 100 patient-years, with a cumulative incidence over the entire follow-up period of 7.7% (95% CI 4.6-12.8).
In real-life conditions, NVAF patients treated with apixaban show rates of treatment discontinuation and major bleedings, which are comparable to those found in the ARISTOTLE pivotal study, thus supporting its external validity.
非维生素 K 拮抗剂口服抗凝剂(NOACs)的真实世界数据在评估这些药物的风险和益处方面发挥着重要作用。我们的目的是评估在非瓣膜性心房颤动(NVAF)患者中使用阿哌沙班治疗的治疗持续时间、大出血发生率和主要事件复合终点(包括全因死亡、心肌梗死、卒中和全身性血栓栓塞)的发生率。
在这项多中心回顾性观察研究中,我们从意大利五家医院的病历中检索了 2014 年 1 月 1 日至 2016 年 3 月 31 日期间诊断为 NVAF 并在同一家医院首次就诊的患者的数据。
我们研究了 766 名平均年龄为 74.2(标准差 11.1)岁的患者,CHADS2 和 CHA2DS2VASc 评分中位数分别为 2.0 和 4.0。在中位数为 339 天的随访期间,治疗的持续率为 83.5%(95%置信区间[95%CI]75.5-89.1%)。大出血(每 100 人年)发生率为 1.15(95%CI 0.39-1.90 每 100 人年),累积发生率为 4.4%(95%CI 1.6-12.0)。主要事件的发生率为 1.97(95%CI 1.08-2.86)每 100 患者年,整个随访期间的累积发生率为 7.7%(95%CI 4.6-12.8)。
在真实环境下,接受阿哌沙班治疗的 NVAF 患者的停药率和大出血发生率与 ARISTOTLE 关键研究中发现的相似,因此支持其外部有效性。