Background

Aspirin (ASA) anti-platelet therapy is mandated with left ventricular assist devices (LVADs) to prevent hemocompatibility-related adverse events (HRAEs). However, the optimal dose of ASA with HeartMate 3 (HM3) LVAD is unknown.

Methods

In an exploratory analysis of HM3-supported patients in the MOMENTUM 3 study (NCT02224755), 2 groups were analyzed: usual-dose (325 mg) and low-dose (81 mg) ASA with anti-coagulation targeted to an international normalized ratio of 2.0 to 3.0. Exclusion criteria included patients not receiving either ASA 81 mg or 325 mg, those with HRAEs ≤7 days after device implantation, and those receiving >1 anti-platelet agent. The primary end-point was survival free from HRAEs (non-surgical bleeding, pump thrombosis, stroke, and peripheral arterial thromboembolic events) at 2 years.

Results

Overall, 321 HM3 patients (usual-dose: n = 141, low-dose: n = 180) were included in this analysis. Usual-dose group patients were younger (57 ± 13 vs 60 ± 12 years, p = 0.035) and less often assigned destination therapy (55% vs 67%, p = 0.029) than low-dose ASA. At 2 years, a similar proportion of patients in the usual- and low-dose groups (43.4% vs 45.3%, p = 0.94) met the primary end-point. There were no differences in survival free from hemorrhagic (usual-dose: 54.4% vs low-dose: 51.7%, p = 0.42) or thrombotic (usual-dose: 76.8% vs low-dose: 75.7%, p = 0.92) events.

Conclusions

Usual- and low-dose ASA revealed similar rates of bleeding and thrombotic events in HM3 LVAD-supported patients within the MOMENTUM 3 trial. Whether ASA therapy provides any meaningful therapeutic effect in patients treated by the HM3 LVAD remains to be determined.

中文翻译：

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阿司匹林剂量对磁悬浮左心室辅助设备对血液相容性相关结局的影响：MOMENTUM 3研究的分析。

背景

左心室辅助装置（LVAD）强制使用阿司匹林（ASA）抗血小板治疗，以预防与血液相容性相关的不良事件（HRAE）。但是，使用HeartMate 3（HM3）LVAD的ASA的最佳剂量尚不清楚。

方法

在MOMENTUM 3研究（NCT02224755）中，对HM3支持的患者进行了探索性分析，分析了2组：常规剂量（325 mg）和低剂量（81 mg）ASA，抗凝的国际标准化比例为2.0至3.0。排除标准包括未接受ASA 81 mg或325 mg的患者，在装置植入后HRAE≤7天的患者以及接受> 1种抗血小板药的患者。主要终点是2年时无HRAE（非手术出血，泵血栓形成，中风和外周动脉血栓栓塞事件）的生存。

结果

总体而言， 该分析包括321例HM3患者（常规剂量：n  = 141，低剂量：n = 180）。 与 低剂量ASA相比，常规剂量组的患者年龄更小（57±13 vs 60±12岁，p = 0.035），分配目的地疗法的频率更低（55％vs 67％，p = 0.029）。在2年时，普通剂量和低剂量组的患者 达到主要终点的比例相似（43.4％vs 45.3％，p = 0.94）。无出血（正常剂量：54.4％vs低剂量：51.7％，p  = 0.42）或血栓形成（正常剂量：76.8％vs低剂量：75.7％，p  = 0.92）事件的存活率没有差异。。

结论

在MOMENTUM 3试验中，常规和低剂量ASA在HM3 LVAD支持的患者中显示了相似的出血和血栓事件发生率。ASA疗法是否对通过HM3 LVAD治疗的患者提供任何有意义的治疗效果尚待确定。