Department of Medicine and Department of Cardiothoracic and Vascular Surgery, Montefiore-Einstein Center for Heart and Vascular Care, Bronx, New York.
Department of Medicine, Columbia University Medical Center, New York, New York.
J Heart Lung Transplant. 2020 Jun;39(6):518-525. doi: 10.1016/j.healun.2020.03.001. Epub 2020 Mar 20.
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.
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.
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.
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.
左心室辅助装置(LVAD)需要阿司匹林(ASA)抗血小板治疗,以预防与血液相容性相关的不良事件(HRAEs)。然而,HeartMate 3(HM3)LVAD 的最佳 ASA 剂量尚不清楚。
在 MOMENTUM 3 研究(NCT02224755)中对接受 HM3 支持的患者进行的一项探索性分析中,分析了 2 组患者:常规剂量(325 mg)和低剂量(81 mg)ASA 联合抗凝治疗,国际标准化比值(INR)目标值为 2.0 至 3.0。排除标准包括未接受任何一种 ASA 81 mg 或 325 mg 治疗、植入装置后 HRAEs 发生时间≤7 天、以及接受>1 种抗血小板药物的患者。主要终点为 2 年时无 HRAEs(非手术性出血、泵血栓形成、卒中、和外周动脉血栓栓塞事件)的存活率。
共有 321 例 HM3 患者(常规剂量组:n=141,低剂量组:n=180)纳入本分析。常规剂量组患者年龄较轻(57±13 岁 vs 60±12 岁,p=0.035),且更倾向于接受终末期治疗(55% vs 67%,p=0.029)。2 年后,常规剂量和低剂量 ASA 组患者的主要终点相似(43.4% vs 45.3%,p=0.94)。两组患者在出血(常规剂量:54.4% vs 低剂量:51.7%,p=0.42)或血栓(常规剂量:76.8% vs 低剂量:75.7%,p=0.92)事件方面无差异。
在 MOMENTUM 3 试验中,HM3 LVAD 支持的患者中,常规剂量和低剂量 ASA 的出血和血栓事件发生率相似。ASA 治疗在 HM3 LVAD 治疗患者中是否具有任何有意义的治疗效果仍有待确定。