The ENSURE-AF study (NCT 02072434) of anticoagulation for electrical cardioversion in nonvalvular atrial fibrillation (NVAF) showed comparable low rates of bleeding and thromboembolism between the edoxaban and the enoxaparin-warfarin treatment arms. This post hoc analysis investigated the relationship between renal function and clinical outcomes. METHODS:ENSURE-AF was a multicenter, PROBE evaluation trial of edoxaban 60 mg, or dose reduced to 30 mg/d for weight≤60 kg, creatinine clearance (CrCl; Cockcroft-Gault) ≤50 mL/min, or concomitant P-glycoprotein inhibitors compared with therapeutically monitored enoxaparin-warfarin in 2,199 NVAF patients undergoing electrical cardioversion. Efficacy and safety outcomes and time in therapeutic range in the warfarin arm were analyzed in relation to CrCl in prespecified ranges ≥15 and ≤30, >30 and ≤50, >50 and <80, and ≥80 mL/min, and an exploratory ≥95-mL/min analysis. RESULTS:A total of 1,095 subjects were randomized to edoxaban and 1,104 to enoxaparin-warfarin. Mean age was 64.3±10 and 64.2±11 years. Mean time in therapeutic range was progressively lower with reducing CrCl strata, being 66.8% in those with CrCl >30 to ≤50 compared with 71.8% in those with CrCl ≥80. The odds ratios for the primary efficacy and safety end points were comparable for the different predefined renal function strata; given the small numbers, the 95% CI included 1.0. In the subset of those with CrCl ≥95, the odds ratios showed consistency with the other CrCl strata. When CrCl was assessed as a continuous variable, there was a nonsignificant trend toward higher major or clinically relevant nonmajor bleeding with reducing CrCl levels, with no significant differences between the 2 treatment arms. When we assessed CrCl at baseline compared with end of treatment, there were no significant differences in CrCl change between the edoxaban and enoxaparin-warfarin arms. The proportions with worsening of renal function (defined as a decrease of >20% from baseline) were similar in the 2 treatment arms. CONCLUSION:Given the small number of events in ENSURE-AF, no effect of renal (dys)function was demonstrated in comparing edoxaban to enoxaparin-warfarin for cardioversion; efficacy and safety of edoxaban remained consistent even in patients with normal or supranormal renal function.

译文

:ENSURE-AF研究(NCT 02072434)在非瓣膜性心房颤动(NVAF)中进行电凝抗凝抗凝研究显示,依多沙班和依诺肝素-华法林治疗组之间的出血和血栓栓塞发生率相当低。事后分析调查了肾功能与临床结局之间的关系。
方法:ENSURE-AF是一项多中心的PROBE评估试验,使用60 mg的埃多沙班,或当体重≤60 kg,肌酐清除率(CrCl; Cockcroft-Gault)≤50mL / min或伴随的P-剂量降低至30 mg / d时糖蛋白抑制剂与依诺肝素-华法林的治疗监测相比,在2199例行心脏电复律的NVAF患者中。分析了华法林组在预定范围≥15和≤30,> 30和≤50,> 50和<80,以及≥80mL / min中与CrCl有关的疗效和安全性结果以及在治疗范围内的时间≥95mL / min分析。
结果:总共1,095名受试者被随机分为依多沙班和1,104名依诺肝素-华法林。平均年龄为64.3±10岁和64.2±11岁。随着CrCl层的减少,治疗范围内的平均时间逐渐缩短,CrCl> 30至≤50的患者为66.8%,而CrCl≥80的患者为71.8%。对于不同的预定义肾功能层,主要疗效和安全终点的比值比是可比的;鉴于数量较少,95%CI包括1.0。在CrCl≥95的那些子集中,优势比显示出与其他CrCl层一致。当将CrCl评估为连续变量时,随着CrCl含量的降低,趋势不明显,即出现更高的主要或临床相关的非主要出血,两个治疗组之间无显着差异。当我们评估与治疗结束时相比基线时的CrCl时,依多沙班和依诺肝素-华法林组之间的CrCl变化没有显着差异。在两个治疗组中,肾功能恶化的比例(定义为比基线降低> 20%)相似。
结论:鉴于ENSURE-AF发生的事件较少,因此在比较依多沙班和依诺肝素-华法林进行心脏复律时,未显示肾脏(功能障碍)的影响;即使在肾功能正常或超正常的患者中,依多沙班的疗效和安全性也保持一致。

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