Direct oral anticoagulants vs warfarin in Asian vs non-Asian patients with atrial fibrillation: a patient-level meta-analysis from COMBINE AF.

Methods

Data from A Collaboration Between Multiple Institutions to Better Investigate Non-Vitamin K Antagonist Oral Anticoagulant Use in Atrial Fibrillation, which pooled patient-level data from the four pivotal randomized trials of direct oral anticoagulants (DOACs) vs warfarin in patients with atrial fibrillation, were analysed.

来自多个机构合作以更好地研究非维生素K拮抗剂口服抗凝药在心房颤动中的使用情况的数据，这些数据汇总了四项关键的随机试验中直接口服抗凝药（DOACs）与华法林在心房颤动患者中的患者级数据，已被分析。

Baseline characteristics and clinical outcomes in patients of Asian race (Asians) vs non-Asian race were compared.

比较了亚洲种族（亚洲人）与非亚洲种族患者的基线特征和临床结果。

The relative efficacy and safety of DOACs compared with warfarin in Asians vs non-Asians, assessing for interactions between race and treatment effect, were investigated.

研究了DOACs与华法林在亚洲人与非亚洲人中的相对疗效和安全性，评估了种族与治疗效果之间的相互作用。

Outcomes across the range of body weight and creatinine clearance in Asians were also explored.

还探讨了在亚洲人体重范围和肌酐清除率的各种结果。

Results

A total of 10 212 Asian patients and 61 471 non-Asians were identified.

共识别出10 212名亚洲患者和61 471名非亚洲患者。

Compared with non-Asians, Asians were on average 3.2 years younger and 20 kg lighter, had worse renal function (mean creatinine clearance 64.9 vs 77.3 mL/min), and had higher rates of prior stroke/transient ischaemic attack (37.2% vs 26.6%) (P < .001 for each).

与非亚洲人相比，亚洲人平均年轻3.2岁，体重轻20公斤，肾功能较差（平均肌酐清除率为64.9 vs 77.3 mL/min），且既往中风/短暂性脑缺血发作的比率较高（37.2% vs 26.6%）（每个P < .001）。

In the warfarin arm (median time in therapeutic range 57.7% for Asians vs 66.2% for non-Asians, P < .001), Asians had a higher adjusted risk of stroke/systemic embolic events (SEEs), major bleeding, intracranial haemorrhage, gastrointestinal bleeding, and primary net clinical outcome (stroke/SEE, major bleeding, or death).

在华法林组（亚洲人的中位治疗范围时间为57.7%，非亚洲人为66.2%，P < .001），亚洲人调整后的中风/全身性栓塞事件（SEEs）、主要出血、颅内出血、胃肠道出血和主要临床结果（中风/SEE、主要出血或死亡）的风险较高。

Compared with warfarin, standard-dose (SD) DOACs significantly reduced the risks in Asians to a greater degree than non-Asians for stroke/SEE (hazard ratio[HR] .65, 95% confidence interval.53-.80 vs HR .86, 95% confidence interval.78-.95), major bleeding (HR .62 [.52-.75] vs HR .91 [.84-.98]), and primary net clinical outcome (HR .76 [.68-.85] vs HR .94 [.90-.98]; Pint < .02 for each).

与华法林相比，标准剂量（SD）的直接口服抗凝药（DOACs）在亚洲人中显著降低了中风/SEE（风险比[HR] .65，95%置信区间 .53-.80 vs HR .86，95%置信区间 .78-.95）、主要出血（HR .62 [.52-.75] vs HR .91 [.84-.98]）和主要临床结局（HR .76 [.68-.85] vs HR .94 [.90-.98]；每个Pint < .02）的风险，降低程度大于非亚洲人。

Standard-dose DOACs increased gastrointestinal bleeding only in non-Asians (Asians HR .92 [.69-1.23] vs non-Asians HR 1.41 [1.25-1.58], Pint = .009).

标准剂量的DOACs仅在非亚洲人中增加了胃肠道出血（亚洲人HR .92 [.69-1.23] vs非亚洲人HR 1.41 [1.25-1.58]，Pint = .009）。

In Asians, SD DOACs reduced the risks of clinical events across the wide range of body weight and creatinine clearance.

在亚洲人中，标准剂量的DOACs在广泛的体重和肌酐清除率范围内降低了临床事件的风险。

Compared with SD DOACs, lower-dose DOACs significantly increased the risk of stroke/SEE (HR 1.57 [1.15-2.13]) and secondary net clinical outcome (stroke/SEE, intracranial haemorrhage, or death; HR 1.23 [1.03-1.48]) in Asians.

与标准剂量的DOACs相比，低剂量的DOACs显著增加了亚洲人中风/SEE（HR 1.57 [1.15-2.13]）和次要临床结局（中风/SEE、颅内出血或死亡；HR 1.23 [1.03-1.48]）的风险。

Conclusions

Clinical outcomes with SD DOACs vs warfarin in patients with atrial fibrillation were generally even more favourable in patients of Asian than non-Asian race.

在房颤患者中，与华法林相比，标准剂量的DOACs在亚洲人中的临床结果通常比非亚洲人更为有利。

Compared with warfarin, SD DOACs did not increase the risk of gastrointestinal bleeding in Asians.

与华法林相比，标准剂量的DOACs在亚洲人中并未增加胃肠道出血的风险。

Standard-dose DOACs are preferred over warfarin or lower-dose DOACs in patients of Asian race.

在亚洲人种患者中，标准剂量的DOACs优于华法林或低剂量的DOACs。