中国新诊断房颤患者抗栓治疗的真实世界时间趋势：来自GLORIA-AF III期注册研究的报告：中国抗栓治疗的使用趋势
Real world time trends in antithrombotic treatment for newly diagnosed atrial fibrillation in China: reports from the GLORIA-AF Phase III registry : Trends in antithrombotic therapy use in China.
作者信息
Liu Xiaoxia, Feng Guoze, Marler Sabrina Vogel, Huisman Menno V, Lip Gregory Y H, Ma Changsheng
机构信息
Department of Cardiology, Beijing An Zhen Hospital, Capital Medical University, Chaoyang District, Beijing, 100029, China.
Boehringer Ingelheim, Shanghai, China.
出版信息
Thromb J. 2023 Aug 1;21(1):83. doi: 10.1186/s12959-023-00527-x.
BACKGROUND
Stroke prevention with oral anticoagulant (OAC) therapy, including non-vitamin K antagonist oral anticoagulants (NOACs), is recommended in patients with atrial fibrillation (AF). This analysis describes the antithrombotic prescription patterns for Chinese patients enrolled post-dabigatran approval during Phase II and III of the Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) program in China.
METHODS
Patients aged ≥ 18 years with newly diagnosed (< 3 months before baseline visit) nonvalvular AF at risk of stroke (CHADS-VASc score ≥ 1) were consecutively enrolled in the GLORIA-AF registry. This cross-sectional analysis provides descriptive comparison of Chinese patients in Phase III (2015-2016) with those enrolled in Phase II (2013-2014).
RESULTS
Overall, 1,018 and 1,911 Chinese patients were eligible for analysis in Phase II and III, respectively. Most patients (69.6% and 69.1%, respectively) had high stroke risk (CHADS-VASc score ≥ 2 for males and ≥ 3 for females). High bleeding risk (HAS-BLED score ≥ 3) rates were similar (17.3% for Phase II, 17.6% for Phase III). In Phase II, 5.8%, 15.2%, 36.7% and 42.2% of patients were prescribed NOACs, vitamin K antagonists (VKAs), antiplatelet therapies or no antithrombotic treatment, respectively. The corresponding figures were 17.2%, 23.5%, 37.4% and 21.8% for patients in Phase III, with an overall increase in OAC prescriptions (NOACs or VKAs). In patients with high stroke risk, the prescription patterns in Phase II were 5.6%, 14.4%, 41.0% and 38.9% for NOACs, VKAs, antiplatelets or no antithrombotic treatment, respectively. The respective proportions in Phase III were 15.1%, 23.5%, 40.9% and 20.5%.
CONCLUSIONS
Since the availability of dabigatran in China, the overall trend of OAC, including NOAC, prescriptions in Chinese patients with nonvalvular AF has increased over time, albeit with VKAs as the most common antithrombotic treatment. Most patients, including those at high stroke risk, remain undertreated according to best practice guidelines.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01468701.
背景
对于心房颤动（AF）患者，推荐使用口服抗凝剂（OAC）治疗进行卒中预防，包括非维生素K拮抗剂口服抗凝剂（NOACs）。本分析描述了在中国房颤患者长期口服抗栓治疗全球注册研究（GLORIA-AF）项目的II期和III期达比加群获批后纳入研究的中国患者的抗栓处方模式。
方法
年龄≥18岁、新诊断（基线访视前<3个月）且有卒中风险（CHADS-VASc评分≥1）的非瓣膜性AF患者连续纳入GLORIA-AF注册研究。本横断面分析对III期（2015 - 2016年）的中国患者与II期（2013 - 2014年）纳入的患者进行了描述性比较。
结果
总体而言，II期和III期分别有1018例和1911例中国患者符合分析条件。大多数患者（分别为69.6%和69.1%）有高卒中风险（男性CHADS-VASc评分≥2，女性≥3）。高出血风险（HAS-BLED评分≥3）率相似（II期为17.3%，III期为17.6%）。在II期，分别有5.8%、15.2%、36.7%和42.2%的患者接受了NOACs、维生素K拮抗剂（VKAs）、抗血小板治疗或未接受抗栓治疗。III期患者的相应数字分别为17.2%、23.5%、37.4%和21.8%，OAC处方（NOACs或VKAs）总体增加。在高卒中风险患者中，II期NOACs、VKAs、抗血小板药物或未接受抗栓治疗的处方模式分别为5.6%、14.4%、41.0%和38.9%。III期的相应比例分别为15.1%、23.5%、40.9%和20.5%。
结论
自中国有达比加群以来，非瓣膜性AF中国患者中OAC（包括NOAC）处方的总体趋势随时间增加，尽管VKA是最常用的抗栓治疗药物。根据最佳实践指南，大多数患者，包括那些高卒中风险患者，仍未得到充分治疗。
试验注册
ClinicalTrials.gov NCT01468701。
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