Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands.
RTI Health Solutions, Research Triangle Institute, Research Triangle Park, North Carolina.
J Am Coll Cardiol. 2017 Feb 21;69(7):777-785. doi: 10.1016/j.jacc.2016.11.061.
GLORIA-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation) is a prospective, global registry program describing antithrombotic treatment patterns in patients with newly diagnosed nonvalvular atrial fibrillation at risk of stroke. Phase 2 began when dabigatran, the first non-vitamin K antagonist oral anticoagulant (NOAC), became available.
This study sought to describe phase 2 baseline data and compare these with the pre-NOAC era collected during phase 1.
During phase 2, 15,641 consenting patients were enrolled (November 2011 to December 2014); 15,092 were eligible. This pre-specified cross-sectional analysis describes eligible patients' baseline characteristics. Atrial fibrillation disease characteristics, medical outcomes, and concomitant diseases and medications were collected. Data were analyzed using descriptive statistics.
Of the total patients, 45.5% were female; median age was 71 (interquartile range: 64, 78) years. Patients were from Europe (47.1%), North America (22.5%), Asia (20.3%), Latin America (6.0%), and the Middle East/Africa (4.0%). Most had high stroke risk (CHADS-VASc [Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, previous Stroke, Vascular disease, Age 65 to 74 years, Sex category] score ≥2; 86.1%); 13.9% had moderate risk (CHADS-VASc = 1). Overall, 79.9% received oral anticoagulants, of whom 47.6% received NOAC and 32.3% vitamin K antagonists (VKA); 12.1% received antiplatelet agents; 7.8% received no antithrombotic treatment. For comparison, the proportion of phase 1 patients (of N = 1,063 all eligible) prescribed VKA was 32.8%, acetylsalicylic acid 41.7%, and no therapy 20.2%. In Europe in phase 2, treatment with NOAC was more common than VKA (52.3% and 37.8%, respectively); 6.0% of patients received antiplatelet treatment; and 3.8% received no antithrombotic treatment. In North America, 52.1%, 26.2%, and 14.0% of patients received NOAC, VKA, and antiplatelet drugs, respectively; 7.5% received no antithrombotic treatment. NOAC use was less common in Asia (27.7%), where 27.5% of patients received VKA, 25.0% antiplatelet drugs, and 19.8% no antithrombotic treatment.
The baseline data from GLORIA-AF phase 2 demonstrate that in newly diagnosed nonvalvular atrial fibrillation patients, NOAC have been highly adopted into practice, becoming more frequently prescribed than VKA in Europe and North America. Worldwide, however, a large proportion of patients remain undertreated, particularly in Asia and North America. (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients With Atrial Fibrillation [GLORIA-AF]; NCT01468701).
GLORIA-AF(全球长期口服抗血栓治疗心房颤动患者注册研究)是一项前瞻性、全球性注册研究项目,旨在描述新诊断为非瓣膜性心房颤动且有卒中风险患者的抗血栓治疗模式。达比加群上市后,研究进入 2 期。
本研究旨在描述 2 期基线数据,并与 1 期的非新型口服抗凝剂(NOAC)时代的数据进行比较。
在 2 期研究中,共纳入 15641 例签署知情同意书的患者(2011 年 11 月至 2014 年 12 月);其中 15092 例患者符合入组条件。本研究采用预先设定的横断面分析描述符合条件患者的基线特征。收集了心房颤动疾病特征、医疗结局以及合并疾病和合并用药的数据。采用描述性统计分析数据。
在所有患者中,45.5%为女性;中位年龄为 71(四分位间距:64,78)岁。患者来自欧洲(47.1%)、北美(22.5%)、亚洲(20.3%)、拉丁美洲(6.0%)和中东/非洲(4.0%)。大多数患者有较高的卒中风险(充血性心力衰竭、高血压、年龄≥75 岁、糖尿病、既往卒中、血管疾病、年龄 65 岁至 74 岁、性别[CHADS-VASc 评分≥2;86.1%];13.9%为中度风险[CHADS-VASc=1])。总体而言,79.9%的患者接受了口服抗凝剂治疗,其中 47.6%接受了 NOAC,32.3%接受了维生素 K 拮抗剂(VKA);12.1%接受了抗血小板治疗;7.8%未接受任何抗血栓治疗。相比之下,1 期患者(n=1063 例,全部符合条件)中接受 VKA 治疗的比例为 32.8%,接受乙酰水杨酸治疗的比例为 41.7%,未接受任何治疗的比例为 20.2%。在 2 期的欧洲,NOAC 的使用率高于 VKA(分别为 52.3%和 37.8%);6.0%的患者接受了抗血小板治疗;3.8%的患者未接受任何抗血栓治疗。在北美,52.1%、26.2%和 14.0%的患者分别接受了 NOAC、VKA 和抗血小板药物治疗;7.5%的患者未接受任何抗血栓治疗。亚洲(27.7%)NOAC 的使用率较低,27.5%的患者接受了 VKA 治疗,25.0%接受了抗血小板药物治疗,19.8%未接受任何抗血栓治疗。
GLORIA-AF 2 期的基线数据表明,在新诊断的非瓣膜性心房颤动患者中,NOAC 已广泛应用于临床实践,在欧洲和北美,NOAC 的应用比 VKA 更为普遍。然而,在全球范围内,仍有很大一部分患者治疗不足,特别是在亚洲和北美。(全球长期口服抗血栓治疗心房颤动患者注册研究[GLORIA-AF];NCT01468701)。