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不同估算肾功能指标在抗凝房颤患者中的再分类、血栓栓塞和大出血结局:来自 PREFER-in-AF 和 PREFER-in-AF 延长登记研究的结果。

Reclassification, Thromboembolic, and Major Bleeding Outcomes Using Different Estimates of Renal Function in Anticoagulated Patients With Atrial Fibrillation: Insights From the PREFER-in-AF and PREFER-in-AF Prolongation Registries.

机构信息

3 Medical Department, Cardiology and Intensive Care Medicine, Wilhelminenhospital, Vienna, Austria (M.R., K.H.).

Institute for Cardiometabolic Diseases, Karl Landsteiner Society, St. Pölten, Austria (M.R.).

出版信息

Circ Cardiovasc Qual Outcomes. 2021 Jun;14(6):e006852. doi: 10.1161/CIRCOUTCOMES.120.006852. Epub 2021 Jun 3.

DOI:10.1161/CIRCOUTCOMES.120.006852
PMID:34078099
Abstract

BACKGROUND

The Cockcroft-Gault formula is recommended to determine a renal indication for dose reduction of dabigatran, edoxaban, and rivaroxaban. Nephrology guidelines now recommend the Modification of Diet in Renal Disease (MDRD) and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formulae as more accurate estimates of glomerular filtration rate.

METHODS

We analyzed anticoagulated patients with atrial fibrillation who were enrolled in the Prevention of Thromboembolic Events - European Registry in Atrial Fibrillation (PREFER in AF). The proportion of patients with dissimilar renal dosing indications was assessed when applying Cockcroft-Gault, MDRD, or CKD-EPI. Thromboembolic and major bleeding events at 1 year were compared in patients in whom Cockcroft-Gault and CKD-EPI provided concordant or discordant results around a threshold of 50 mL/minute.

RESULTS

Out of 1288 patients with atrial fibrillation with chronic kidney disease in whom Cockcroft-Gault suggested a dose reduction of dabigatran, edoxaban, or rivaroxaban (creatinine clearance ≤50 mL/minutes), 19% and 16% were reclassified to the respective higher doses, and 24% and 23% to the respective lower doses by applying the MDRD and CKD-EPI formulae, respectively. In patients potentially receiving a different dose of dabigatran, edoxaban, or rivaroxaban when using CKD-EPI, we observed an excess of thromboembolic events (4.1% versus 0.8%; odds ratio, 5.5 [95% CI, 1.5-20.8]; =0.01). Major bleeding rates were nonsignificantly different in the discordance versus concordance group (5.7% versus 2.7%; odds ratio, 2.2 [95% CI, 0.9-5.6]; =0.09).

CONCLUSIONS

The MDRD and CKD-EPI formulae suggest a different dosing in up to a quarter of anticoagulated patients with atrial fibrillation. This seems to impact hard outcomes.

摘要

背景

推荐 Cockcroft-Gault 公式来确定达比加群、依度沙班和利伐沙班的肾脏剂量调整指征。肾脏病学指南现在推荐使用改良肾脏病膳食研究(MDRD)和慢性肾脏病流行病学合作(CKD-EPI)公式,因为这些公式对肾小球滤过率的估计更准确。

方法

我们分析了在预防血栓栓塞事件-房颤欧洲登记处(PREFER in AF)中接受抗凝治疗的房颤患者。当应用 Cockcroft-Gault、MDRD 或 CKD-EPI 公式时,评估了不同肾脏剂量指征的患者比例。在 Cockcroft-Gault 和 CKD-EPI 提供 50ml/min 阈值左右的一致或不一致结果的患者中,比较了 1 年内的血栓栓塞和大出血事件。

结果

在 1288 名患有慢性肾脏病的房颤患者中,Cockcroft-Gault 提示达比加群、依度沙班或利伐沙班剂量减少(肌酐清除率≤50ml/min),19%和 16%分别被重新分类为更高剂量,24%和 23%分别被重新分类为更低剂量,应用 MDRD 和 CKD-EPI 公式。在应用 CKD-EPI 时,患者可能会接受不同剂量的达比加群、依度沙班或利伐沙班,我们观察到血栓栓塞事件的发生率增加(4.1%比 0.8%;优势比,5.5[95%CI,1.5-20.8];=0.01)。在不一致与一致组中,大出血发生率无显著差异(5.7%比 2.7%;优势比,2.2[95%CI,0.9-5.6];=0.09)。

结论

MDRD 和 CKD-EPI 公式提示高达四分之一的房颤抗凝患者需要不同的剂量。这似乎会影响硬终点。

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