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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
Circulation: Cardiovascular Quality and Outcomes ( IF 6.2 ) Pub Date : 2021-06-03 , DOI: 10.1161/circoutcomes.120.006852
Miklos Rohla 1, 2 , Ladislav Pecen 3 , Roberto Cemin 4 , Giuseppe Patti 5 , Jolanta M Siller-Matula 6, 7 , Renate B Schnabel 8 , Kurt Huber 1, 9 , Paulus Kirchhof 10 , Raffaele De Caterina 11
Affiliation  

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]; P=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]; P=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.

中文翻译:

在房颤抗凝患者中使用不同肾功能评估的重新分类、血栓栓塞和主要出血结果:来自 PREFER-in-AF 和 PREFER-in-AF 延长登记的见解

背景:推荐使用 Cockcroft-Gault 公式来确定减少达比加群、依度沙班和利伐沙班剂量的肾脏适应症。肾脏病学指南现在推荐肾病饮食调整 (MDRD) 和慢性肾病流行病学合作 (CKD-EPI) 公式作为肾小球滤过率的更准确估计。方法:我们分析了参与预防的房颤抗凝患者血栓栓塞事件——欧洲心房颤动登记处(房颤首选)。在应用 Cockcroft-Gault、MDRD 或 CKD-EPI 时,评估了具有不同肾脏给药适应症的患者比例。在 Cockcroft-Gault 和 CKD-EPI 在阈值 50 mL/min 附近提供一致或不一致结果的患者中,比较了 1 年的血栓栓塞和大出血事件。结果:在 1288 名患有慢性肾病的心房颤动患者中Cockcroft-Gault 建议减少达比加群、依度沙班或利伐沙班的剂量(肌酐清除率 ≤ 50 mL/分钟),19% 和 16% 被重新归类为各自的较高剂量,24% 和 23% 被重新归类为各自的较低剂量分别为 MDRD 和 CKD-EPI 公式。在使用 CKD-EPI 时可能接受不同剂量达比加群、依度沙班或利伐沙班的患者中,我们观察到血栓栓塞事件过多(4.1% 对 0.8%;优势比,5.5 [95% CI,1.5-20.8];在 Cockcroft-Gault 建议减少达比加群、依度沙班或利伐沙班剂量(肌酐清除率 ≤50 mL/分钟)的 1288 名患有慢性肾病的房颤患者中,19% 和 16% 被重新分类为各自的更高剂量,通过应用 MDRD 和 CKD-EPI 公式,分别为各自的较低剂量降低了 24% 和 23%。在使用 CKD-EPI 时可能接受不同剂量达比加群、依度沙班或利伐沙班的患者中,我们观察到血栓栓塞事件过多(4.1% 对 0.8%;优势比,5.5 [95% CI,1.5-20.8];在 Cockcroft-Gault 建议减少达比加群、依度沙班或利伐沙班的剂量(肌酐清除率≤50 mL/分钟)的 1288 名患有慢性肾病的房颤患者中,19% 和 16% 被重新分类为各自的更高剂量,通过应用 MDRD 和 CKD-EPI 公式,分别为各自的较低剂量降低了 24% 和 23%。在使用 CKD-EPI 时可能接受不同剂量达比加群、依度沙班或利伐沙班的患者中,我们观察到血栓栓塞事件过多(4.1% 对 0.8%;优势比,5.5 [95% CI,1.5-20.8];通过应用 MDRD 和 CKD-EPI 公式,分别为各自的较低剂量降低了 24% 和 23%。在使用 CKD-EPI 时可能接受不同剂量达比加群、依度沙班或利伐沙班的患者中,我们观察到血栓栓塞事件过多(4.1% 对 0.8%;优势比,5.5 [95% CI,1.5-20.8];通过应用 MDRD 和 CKD-EPI 公式,分别为各自的较低剂量降低了 24% 和 23%。在使用 CKD-EPI 时可能接受不同剂量达比加群、依度沙班或利伐沙班的患者中,我们观察到血栓栓塞事件过多(4.1% 对 0.8%;优势比,5.5 [95% CI,1.5-20.8];P = 0.01)。不一致组与一致组的主要出血率无显着差异(5.7% 与 2.7%;优势比,2.2 [95% CI,0.9–5.6];P = 0.09)。结论:MDRD 和 CKD-EPI 公式表明不同多达四分之一的房颤患者接受抗凝治疗。这似乎会影响硬结果。
更新日期:2021-06-15
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