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心房颤动患者的临床复杂性领域、抗凝治疗与结局:GLORIA-AF 注册研究 II 期和 III 期报告。

Clinical Complexity Domains, Anticoagulation, and Outcomes in Patients with Atrial Fibrillation: A Report from the GLORIA-AF Registry Phase II and III.

机构信息

Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom.

Department of Translational and Precision Medicine, Sapienza University of Rome, Rome, Italy.

出版信息

Thromb Haemost. 2022 Dec;122(12):2030-2041. doi: 10.1055/s-0042-1756355. Epub 2022 Aug 29.

Abstract

BACKGROUND

Clinical complexity is common in atrial fibrillation (AF) patients. We assessed the impact of clinical complexity on oral anticoagulant (OAC) treatment patterns and major adverse outcomes in a contemporary cohort of AF patients.

METHODS

The GLORIA-AF Phase II and III Registry enrolled newly diagnosed AF patients with at least one stroke risk factor. Among patients with CHADS-VASc score ≥2, we defined four domains of perceived clinical complexity: frail elderly (age ≥75 years and body mass index <23 kg/m), chronic kidney disease (CKD, creatinine clearance <60 mL/min), history of bleeding, and those with ≥2 of the above conditions. We evaluated the associations between clinical complexity domains and antithrombotic treatment prescription, risk of OAC discontinuation, and major adverse outcomes.

RESULTS

Among the 29,625 patients included (mean age 69.6 ± 10.7 years, 44.2% females), 9,504 (32.1%) presented with at least one complexity criterion. Clinical complexity was associated with lower OAC prescription, with stronger associations in frail elderly (odds ratio [OR]: 0.47, 95% confidence interval [CI]: 0.36-0.62) and those with ≥2 complexity domains (OR: 0.50, 95% CI: 0.44-0.57). Risk of OAC discontinuation was higher among frail elderly (hazard ratio [HR]: 1.30, 95% CI: 1.00-1.69), CKD (HR: 1.10, 95% CI: 1.02-1.20), and those with ≥2 complexity domains (HR: 1.39, 95% CI: 1.23-1.57). Clinical complexity was associated with higher risk of the primary outcome of all-cause death, thromboembolism, and major bleeding, with the highest magnitude in those with ≥2 criteria (HR: 1.63, 95% CI: 1.43-1.86).

CONCLUSION

In AF patients, clinical complexity influences OAC treatment management, and increases the risk of poor clinical outcomes. These patients require additional efforts, such as integrated care approach, to improve their management and prognosis.

摘要

背景

临床复杂性在心房颤动(AF)患者中很常见。我们评估了临床复杂性对口服抗凝剂(OAC)治疗模式和 AF 患者主要不良结局的影响。

方法

GLORIA-AF 二期和三期注册研究纳入了至少有一个卒中危险因素的新诊断为 AF 的患者。在 CHADS-VASc 评分≥2 的患者中,我们定义了四个感知到的临床复杂性领域:虚弱的老年人(年龄≥75 岁且体重指数<23kg/m²)、慢性肾脏病(CKD,肌酐清除率<60ml/min)、出血史和有≥2 种上述情况。我们评估了临床复杂性领域与抗血栓治疗处方、OAC 停药风险和主要不良结局之间的关联。

结果

在纳入的 29625 例患者中(平均年龄 69.6±10.7 岁,44.2%为女性),9504 例(32.1%)存在至少一个复杂性标准。临床复杂性与 OAC 处方率较低相关,在虚弱的老年人(比值比 [OR]:0.47,95%置信区间 [CI]:0.36-0.62)和有≥2 个复杂领域的患者(OR:0.50,95% CI:0.44-0.57)中具有更强的相关性。在虚弱的老年人(风险比 [HR]:1.30,95% CI:1.00-1.69)、CKD(HR:1.10,95% CI:1.02-1.20)和有≥2 个复杂领域的患者(HR:1.39,95% CI:1.23-1.57)中,OAC 停药风险更高。临床复杂性与全因死亡、血栓栓塞和大出血的主要结局风险增加相关,在有≥2 个标准的患者中风险最高(HR:1.63,95% CI:1.43-1.86)。

结论

在 AF 患者中,临床复杂性影响 OAC 治疗管理,并增加不良临床结局的风险。这些患者需要额外的努力,例如综合护理方法,以改善他们的管理和预后。

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