Aspirin dosing after acute coronary syndrome with suspected aspirin resistance: the ANDAMAN trial.

Whether twice-daily aspirin dosing reduces major adverse cardiovascular events (MACE) in this population remains unknown.

这种人群是否通过每日两次服用阿司匹林可以减少主要不良心血管事件（MACE）尚不清楚。

Methods

In this prospective multicentre, randomized trial, patients with ACS and DM or high-risk of aspirin resistance (HRAR) defined as: (i) an index event occurring while on aspirin; (ii) body mass index ≥27 kg/m2; or (iii) increased waist circumference were assigned to receive enteric-coated aspirin once daily (100 mg/day) or twice daily (100 mg morning and evening).

在这项前瞻性多中心随机试验中，患有急性冠脉综合征（ACS）和糖尿病（DM）或高风险的阿司匹林抵抗（HRAR）的患者被定义为：（i）在服用阿司匹林期间发生索引事件；（ii）体质指数（BMI）≥27 kg/m2；或（iii）腰围增加，被分配每天一次（100 mg/天）或每天两次（早上100 mg和晚上100 mg）服用肠溶阿司匹林。

The primary outcome was MACE, a composite of any death, myocardial infarction, stroke, urgent coronary revascularization, stent thrombosis, or acute arterial thrombotic event assessed using a time-to-first-event analysis.

主要结果是主要不良心血管事件（MACE），这是一个复合结果，包括任何死亡、心肌梗死、中风、紧急冠状动脉再血管化、支架血栓形成或急性动脉血栓事件，使用首次事件时间分析进行评估。

The main secondary outcome was major bleeding (Bleeding Academic Research Consortium type 3-5).

主要次要结果是主要出血（Bleeding Academic Research Consortium 3-5型）。

Results

In total, 2484 participants were enrolled (77.2% with DM, 55.5% with ST-elevation segment myocardial infarction).

共有2484名参与者被纳入研究（其中77.2%患有糖尿病，55.5%患有ST段抬高型心肌梗死）。

The median follow-up duration was 18 (interquartile range: 17.6-18.3) months.

中位随访时间为18个月（四分位数范围：17.6-18.3个月）。

The primary outcome occurred in 95 of 1228 participants (7.7%) in the twice-daily aspirin group, and 110 of 1256 (8.8%) in the once-daily group (hazard ratio[HR] 0.90; 95% confidence interval[CI] 0.69-1.19; P = .42).

主要结局事件在每日两次阿司匹林组的1228名参与者中有95人（7.7%）发生，而在每日一次组的1256名中有110人（8.8%）发生（风险比[HR] 0.90；95%置信区间[CI] 0.69-1.19；P = .42）。

Major bleeding rates were similar between the groups (1.9% vs 2.1%; HR 0.88; 95% CI 0.50-1.55).

两组间主要出血率相似（1.9%对比2.1%；HR 0.88；95% 置信区间 0.50-1.55）。

Conclusions

In patients with ACS and DM or HRAR, twice-daily aspirin did not significantly reduce the risk of MACE compared to once-daily dosing.

在急性冠脉综合征伴有糖尿病或高风险动脉粥样硬化患者中，每日两次阿司匹林与每日一次相比，并未显著降低主要不良心血管事件（MACE）的风险。

No significant difference was observed in major bleeding between groups.

在主要出血事件方面，两组之间未观察到显著差异。

trial_registration

NCT02520921/EUDRACT No: 2015-000947-18.

NCT02520921/EUDRACT编号：2015-000947-18。