Background and purpose: The effectiveness and safety of edoxaban 60 mg and 30 mg for stroke prevention compared with warfarin in patients with atrial fibrillation (AF) has not been well-described in a nationwide cohort of Caucasian patients treated in standard clinical practice.

Methods: We used Danish nationwide registries to identify patients with AF during June 2016 and November 2018 who were treated with edoxaban or warfarin and computed rates per 100 person-years of thromboembolic, all-cause mortality, and bleeding events using an inverse probability of treatment weighting approach to account for baseline confounding. We used weighted pooled logistic regression to compute hazard ratios (HRs) with 95% confidence intervals (CIs) comparing events between edoxaban 60 mg and warfarin users; edoxaban 30 mg was not included in formal comparisons.

Results: We identified 6451 AF patients, mean age was 72 years and 40% were females. A total of 1772 patients were treated with edoxaban 60 mg, 537 with edoxaban 30 mg, and 4142 with warfarin. The median CHA2DS2-VASc score was similar between warfarin and edoxaban 60 mg with a score of 3 (interquartile range [IQR] 2-4). In the inverse probability of treatment-weighted pseudo-population, the thromboembolic event rate for edoxaban 60 mg was 0.95 and 1.0 for warfarin, corresponding weighted HR of 1.00 (95% confidence intervals [CI] 0.59, 1.71). Edoxaban 60 mg users were associated with lower rates of all-cause mortality (3.93) compared to warfarin (6.04), with a HR of 0.64 (95% CI 0.47 to 0.88). The event rates for bleeding were 3.36 and 3.14, respectively; HR 1.09 (95% CI 0.77, 1.57)

Conclusion: Edoxaban 60 mg is a safe and effective treatment compared with warfarin for stroke prevention in routine clinical care for white European patients with AF, with non-significantly different risks for stroke and clinically relevant bleeding, but lower all-cause mortality. 

背景和目的：在标准临床实践中接受治疗的全国高加索患者队列中，与华法林相比，艾多沙班 60 mg 和 30 mg 用于预防中风的有效性和安全性尚未得到很好的描述。

方法：我们使用丹麦全国登记来确定 2016 年 6 月和 2018 年 11 月期间接受依度沙班或华法林治疗的 AF 患者，并使用逆治疗概率计算每 100 人年血栓栓塞、全因死亡率和出血事件的发生率加权方法来解释基线混杂。我们使用加权汇总逻辑回归来计算具有 95% 置信区间 (CIs) 的风险比 (HRs)，比较 edoxaban 60 mg 和华法林使用者之间的事件；依度沙班 30 mg 未包括在正式比较中。

结果：我们确定了 6451 名 AF 患者，平均年龄为 72 岁，其中 40% 为女性。共有 1772 名患者接受了 60 mg 艾多沙班治疗，537 名患者接受了艾多沙班 30 mg 治疗，4142 名患者接受了华法林治疗。华法林和依度沙班 60 mg 的中位 CHA2DS2-VASc 评分相似，评分为 3（四分位距 [IQR] 2-4）。在治疗加权伪人群的逆概率中，依度沙班 60 mg 的血栓栓塞事件发生率为 0.95，华法林为 1.0，相应的加权 HR 为 1.00（95% 置信区间 [CI] 0.59, 1.71）。与华法林 (6.04) 相比，使用 Edoxaban 60 mg 的全因死亡率 (3.93) 较低，HR 为 0.64 (95% CI 0.47 至 0.88)。出血事件发生率分别为 3.36 和 3.14；HR 1.09 (95% CI 0.77, 1.57)

结论：在欧洲白人房颤患者的常规临床护理中，与华法林相比，艾多沙班 60 mg 是一种安全有效的卒中预防治疗，卒中和临床相关出血风险无显着差异，但全因死亡率较低。 ƒ