University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham B18 7QH, UK.
Eur Heart J. 2013 Dec;34(46):3572-9. doi: 10.1093/eurheartj/eht328. Epub 2013 Aug 21.
Limited data are available on the impact of renal function on the outcome of patients with atrial fibrillation (AF).
AMADEUS was a multicentre, randomized, open-label non-inferiority study that compared fixed-dose idraparinux with conventional anticoagulation by dose-adjusted vitamin K antagonists. We performed a post hoc analysis to assess the impact of renal function on the outcomes of anticoagulated AF patients. The primary efficacy outcome was the composite of stroke/systemic embolism (SE). The principal safety outcome of this analysis was major bleeding. We calculated c-indexes, reflecting the ability for discriminating diseased vs. non-diseased patients, and the net reclassification improvement (NRI, an index of inferior/superior performance of risk estimation scores). Of 4576 patients, 45 strokes and 103 major bleeding events occurred following an average follow-up of 325 ± 164 days. Patients with CrCl >90 mL/min had an annual stroke/SE rate of 0.6% compared with 0.8% for those with CrCl 60-90 mL/min and 2.2% for those with CrCl <60 mL/min (P < 0.001 for linear association). After adjusting for stroke risk factors, patients with CrCl <60 mL/min had more than two-fold higher risk of stroke/SE and almost 60% higher risk of major bleeding compared with those with CrCl ≥60. In patients with the CHA2DS2VASc score 1-2, CrCl <60 mL/min was associated with eight-fold higher stroke risk. When added to the CHA2DS2VASc or CHADS2 scores, CrCl <60 mL/min did not improve the c-indexes for CHADS2 (P = 0.054) or CHA2DS2VASc (P = 0.63) but resulted in significant NRI (0.26, P = 0.02) in this anticoagulated trial cohort.
Renal impairment (CrCl <60 mL/min) doubles the risk of stroke and increased the risk of major bleeding by almost 60% in anticoagulated patients with AF. Renal impairment was additive to stroke risk prediction scores based on a significant NRI, but no significant improvement in discrimination ability (based on c-indexes) for CHA2DS2VASc or CHADS2 was observed.
关于肾功能对房颤（AF）患者结局的影响，目前仅有有限的数据。
AMADEUS 是一项多中心、随机、开放标签、非劣效性研究，比较了固定剂量依达肝素与剂量调整的维生素 K 拮抗剂的常规抗凝治疗。我们进行了一项事后分析，以评估肾功能对接受抗凝治疗的 AF 患者结局的影响。主要疗效终点是卒中/全身性栓塞（SE）的复合终点。本分析的主要安全性结局是大出血。我们计算了 C 指数，该指数反映了区分患病和非患病患者的能力，以及净重新分类改善（NRI，风险评估评分表现优劣的指标）。在 4576 例患者中，平均随访 325±164 天后，发生了 45 例卒中和 103 例大出血事件。CrCl＞90ml/min 的患者年卒中/SE 发生率为 0.6%，CrCl 为 60-90ml/min 的患者为 0.8%，CrCl＜60ml/min 的患者为 2.2%（线性关联，P＜0.001）。在校正卒中危险因素后，CrCl＜60ml/min 的患者卒中/SE 的风险增加了两倍以上，大出血的风险增加了近 60%，与 CrCl≥60ml/min 的患者相比。在 CHA2DS2VASc 评分为 1-2 的患者中，CrCl＜60ml/min 与卒中风险增加 8 倍相关。当将 CrCl＜60ml/min 添加到 CHA2DS2VASc 或 CHADS2 评分中时，CrCl＜60ml/min 并没有改善 CHADS2（P=0.054）或 CHA2DS2VASc（P=0.63）的 C 指数，但在这个抗凝试验队列中，显著的 NRI（0.26，P=0.02）。
在接受抗凝治疗的 AF 患者中，肾功能损害（CrCl＜60ml/min）使卒中风险增加一倍，并使大出血风险增加近 60%。肾功能损害与基于显著 NRI 的基于卒中风险预测评分相加，但未观察到 CHA2DS2VASc 或 CHADS2 的判别能力（基于 C 指数）显著改善。
