Concomitant Surgical Procedures and Aspirin Avoidance With Left Ventricular Assist Device Therapy

IF 10.3 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Heart failure Pub Date : 2025-07-01 DOI:10.1016/j.jchf.2025.01.017

Francis D. Pagani MD, PhD , Ivan Netuka MD, PhD , Ulrich P. Jorde MD , Jason N. Katz MD, MHS , Finn Gustafsson MD, PhD , Jean M. Connors MD , Nir Uriel MD, MSc , Edward G. Soltesz MD , Peter Ivak MD, PhD , Aditya Bansal MD , Abbas Bitar MD , J. David Vega MD , Daniel Goldstein MD , Matthew Danter MD , Yuriy Pya MD, DMSc , Ashwin Ravichandran MD , Jennifer Conway MD , Eric D. Adler MD , Eugene S. Chung MD , Jonathan Grinstein MD , Mandeep R. Mehra MD, MSc

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引用次数: 0

Abstract

Background

ARIES-HM3 (Antiplatelet Removal and Hemocompatibility Events With the HeartMate 3 Pump) demonstrated that aspirin avoidance with a fully magnetically levitated HeartMate 3 (HM3) left ventricular assist device (LVAD) reduces bleeding complications and does not increase thromboembolism. Whether a concomitant surgical procedure modifies the observed safety and benefits remains uncertain.

Objectives

This prespecified analysis of ARIES-HM3 studied clinical outcomes when concomitant surgical procedures are performed during LVAD implantation with excluding aspirin but maintaining a vitamin K antagonist.

Methods

Among 628 patients randomized to receive either placebo or aspirin with a vitamin K antagonist, 589 (296 placebo and 293 aspirin) contributed to the primary endpoint analysis. Sub-categorization with receiving a concomitant surgical procedure (valvular procedure/coronary artery bypass grafting or nonvalvular procedure) was done and the composite primary endpoint of survival free from major nonsurgical (>14 days postimplant) hemocompatibility-related adverse events at 12 months was assessed.

Results

There were 155 (52%) and 145 (49%) concomitant procedures in placebo and aspirin arms, respectively. The percentage of subjects achieving primary endpoint success was higher with the placebo group in patients with a concomitant procedure, and no interaction was observed on primary outcomes between those with and without concomitant surgical procedures (P_int = 0.231, 0.298, and 0.735 for any procedure, valvular/coronary artery bypass grafting, and nonvalvular procedures, respectively). There was a similar reduction in nonsurgical major hemorrhagic events with placebo compared with aspirin, observed in patients with or without any concomitant procedure: 0.64 (95% CI: 0.44-0.94) and 0.66 (95% CI: 0.46-0.93).

Conclusions

Our findings support the safety and efficacy of aspirin avoidance from the antithrombotic regimen in HM3 LVAD patients undergoing concomitant surgical procedures. (Antiplatelet Removal and Hemocompatibility Events With the HeartMate 3 Pump [ARIES-HM3]; NCT04069156)

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伴随外科手术和左心室辅助装置治疗避免阿司匹林。

背景：白羊座-HM3（心脏伴侣3泵的抗血小板去除和血液相容性事件）表明，完全磁悬浮心脏伴侣3 （HM3）左心室辅助装置（LVAD）避免阿司匹林可减少出血并发症，不会增加血栓栓塞。是否同时进行外科手术会改变观察到的安全性和益处仍不确定。目的：这项预先指定的ARIES-HM3分析研究了在LVAD植入期间，在排除阿司匹林但维持维生素K拮抗剂的情况下，进行伴随手术的临床结果。方法：在628名随机接受安慰剂或阿司匹林联合维生素K拮抗剂的患者中，589名（296名安慰剂和293名阿司匹林）参与了主要终点分析。对接受合并手术（瓣膜手术/冠状动脉旁路移植术或非瓣膜手术）的患者进行亚分类，并评估12个月时无主要非手术（植入后14天）血液相容性相关不良事件的复合主要生存终点。结果：安慰剂组和阿司匹林组分别有155例（52%）和145例（49%）合并手术。在合并手术的患者中，安慰剂组获得主要终点成功的比例更高，并且在合并和不合并手术的患者之间的主要结果没有观察到相互作用（对于任何手术，瓣膜/冠状动脉搭桥术和非瓣膜手术，Pint分别= 0.231,0.298和0.735）。与阿司匹林相比，在接受或不接受任何伴随手术的患者中，安慰剂的非手术大出血事件减少率相似：0.64 （95% CI: 0.44-0.94）和0.66 （95% CI: 0.46-0.93）。结论：我们的研究结果支持在接受外科手术的HM3 LVAD患者抗血栓治疗方案中避免使用阿司匹林的安全性和有效性。心脏伴侣3型泵的抗血小板清除和血液相容性事件[ARIES-HM3]；NCT04069156)。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

JACC. Heart failure CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

21.20

自引率

2.30%

发文量

164

期刊介绍： JACC: Heart Failure publishes crucial findings on the pathophysiology, diagnosis, treatment, and care of heart failure patients. The goal is to enhance understanding through timely scientific communication on disease, clinical trials, outcomes, and therapeutic advances. The Journal fosters interdisciplinary connections with neuroscience, pulmonary medicine, nephrology, electrophysiology, and surgery related to heart failure. It also covers articles on pharmacogenetics, biomarkers, and metabolomics.