Background

Although randomized trials provide a high level of evidence regarding the efficacy of non-vitamin K oral anticoagulants (NOACs), the results of such trials may differ from those observed in day-to-day clinical practice.

Aims

To compare the risk of stroke/systemic embolism (S/SE) and major bleeding (MB) between NOAC and warfarin in clinical practice.

Methods

Patients with non-valvular atrial fibrillation (NVAF) who started warfarin/NOACs between January 2015 and November 2016 were retrospectively identified from Korea’s nationwide health insurance claims database. Using inpatient diagnosis and imaging records, the Cox models with inverse probability of treatment weighting using propensity scores were used to estimate hazard ratios (HRs) for NOACs relative to warfarin.

Results

Of the 48,389 patients, 10,548, 11,414, 17,779 and 8,648 were administered apixaban, dabigatran, rivaroxaban and warfarin, respectively. Many patients had suffered prior strokes (36.7%, 37.7%, 31.4%, and 32.2% in apixaban, dabigatran, rivaroxaban, and warfarin group, respectively), exhibited high CHA₂DS₂-VASc (4.8, 4.6, 4.6, and 4.1 in apixaban, dabigatran, rivaroxaban, and warfarin group, respectively) and HAS-BLED (3.7, 3.6, 3.6, and 3.3 in apixaban, dabigatran, rivaroxaban, and warfarin group, respectively) scores, had received antiplatelet therapy (75.4%, 75.7%, 76.8%, and 70.1% in apixaban, dabigatran, rivaroxaban, and warfarin group, respectively), or were administered reduced doses of NOACs (49.8%, 52.9%, and 42.8% in apixaban, dabigatran, and rivaroxaban group, respectively). Apixaban, dabigatran and rivaroxaban showed a significantly lower S/SE risk [HR, 95% confidence intervals (CI): 0.62, 0.54–0.71; 0.60, 0.53–0.69; and 0.71, 0.56–0.88, respectively] than warfarin. Apixaban and dabigatran (HR, 95% CI: 0.58, 0.51–0.66 and 0.75, 0.60–0.95, respectively), but not rivaroxaban (HR, 95% CI: 0.84, 0.69–1.04), showed a significantly lower MB risk than warfarin.

Conclusions

Among Asian patients who were associated with higher bleeding risk, low adherence, and receiving reduced NOAC dose than that provided in randomised controlled trials, all NOACs were associated with a significantly lower S/SE risk and apixaban and dabigatran with a significantly lower MB risk than warfarin.

中文翻译：

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与华法林相比，接受非维生素 K 口服抗凝剂治疗的亚洲非瓣膜性心房颤动患者中风/全身性栓塞和大出血的风险：真实世界数据分析的结果

背景

尽管随机试验提供了关于非维生素 K 口服抗凝剂 (NOAC) 功效的高水平证据，但此类试验的结果可能与日常临床实践中观察到的结果不同。

目标

比较临床实践中 NOAC 和华法林的卒中/全身性栓塞 (S/SE) 和大出血 (MB) 风险。

方法

从韩国全国健康保险索赔数据库中回顾性确定了 2015 年 1 月至 2016 年 11 月期间开始使用华法林/NOAC 的非瓣膜性心房颤动 (NVAF) 患者。使用住院患者诊断和影像记录，使用倾向评分的治疗加权逆概率 Cox 模型来估计 NOAC 相对于华法林的风险比 (HR)。

结果

在 48,389 名患者中，分别有 10,548 名、11,414 名、17,779 名和 8,648 名患者接受了阿哌沙班、达比加群、利伐沙班和华法林治疗。许多患者既往患有中风（阿哌沙班组、达比加群组、利伐沙班组和华法林组分别为 36.7%、37.7%、31.4% 和 32.2%），表现出高 CHA ₂ DS ₂ -VASc（4.8、4.6、4.6 和 4.1）阿哌沙班、达比加群、利伐沙班和华法林组分别为 3.7、3.6、3.6 和 3.3）评分，已接受抗血小板治疗（75.4%、75.7）阿哌沙班、达比加群、利伐沙班和华法林组分别为 %、76.8% 和 70.1%），或给予减少剂量的 NOAC（阿哌沙班、达比加群、利伐沙班组分别为 49.8%、52.9% 和 42.8%） 。阿哌沙班、达比加群和利伐沙班显示出显着较低的 S/SE 风险 [HR，95% 置信区间 (CI)：0.62、0.54–0.71；0.60、0.53–0.69；和0.71，0.56-0.88，分别]比华法林。阿哌沙班和达比加群（HR，95% CI：分别为 0.58、0.51-0.66 和 0.75、0.60-0.95），但利伐沙班（HR，95% CI：0.84、0.69-1.04）的 MB 风险显着低于华法林。

结论

在出血风险较高、依从性较低且接受的 NOAC 剂量比随机对照试验中提供的剂量减少的亚洲患者中，所有 NOAC 均与显着较低的 S/SE 风险相关，而阿哌沙班和达比加群的 MB 风险显着低于随机对照试验中提供的剂量。华法林。