{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T08:08:15Z","timestamp":1791878895268,"version":"4.3.4"},"reference-count":26,"publisher":"American Medical Association (AMA)","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Cardiol"],"published-print":{"date-parts":[[2025,3,1]]},"abstract":"<jats:sec><jats:title>Importance<\/jats:title><jats:p>The Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure (ARIES-HM3) study demonstrated that aspirin may be safely eliminated from the antithrombotic regimen after HeartMate 3 (HM3 [Abbott Cardiovascular]) left ventricular assist device (LVAD) implantation. This prespecified analysis explored whether conditions requiring aspirin (prior percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG], stroke, or peripheral vascular disease [PVD]) would influence outcomes differentially with aspirin avoidance.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>To analyze aspirin avoidance on hemocompatibility-related adverse events (HRAEs) at 1 year after implant in patients with a history of CABG, PCI, stroke, or PVD.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design, Setting, and Participants<\/jats:title><jats:p>This was an international, multicenter, prospective, double-blind, placebo-controlled, randomized clinical trial including patients implanted with a de novo HM3 LVAD across 51 centers. Data analysis was conducted from April to July 2024.<\/jats:p><\/jats:sec><jats:sec><jats:title>Interventions<\/jats:title><jats:p>Patients were randomized in a 1:1 ratio to receive aspirin (100 mg per day) or placebo, in addition to a vitamin K antagonist (VKA) targeted to an international normalized ratio of 2 to 3 in both groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Main Outcomes and Measures<\/jats:title><jats:p>Primary end point (assessed for noninferiority) was a composite of survival free of any nonsurgical (&amp;amp;gt;14 days after implant) HRAEs including stroke, pump thrombosis, bleeding, and arterial peripheral thromboembolism at 12 months. Secondary end points included nonsurgical bleeding, stroke, and pump thrombosis events.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Among 589 of 628 patients (mean [SD] age, 57.1 [13.7] years; 456 male [77.4%]) who contributed to the primary end point analysis, a history of PCI, CABG, stroke, or PVD was present in 41% (240 of 589 patients). There was no interaction between the presence of an atherosclerotic vascular condition and effect of aspirin compared with placebo (<jats:italic>P<\/jats:italic> for interaction= .23). The preset 10% noninferiority margin was not crossed for the studied subgroup of patients. Thrombotic events were rare, with no differences between aspirin and placebo in patients with and without vascular disease (<jats:italic>P<\/jats:italic> for interaction = .77). Aspirin treatment was associated with a higher rate of nonsurgical major bleeding events in the group with prior vascular condition history compared with those without aspirin (rate ratio for placebo compared with aspirin, 0.52; 95% CI, 0.35-0.79).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions and Relevance<\/jats:title><jats:p>Results of this prespecified analysis of the ARIES-HM3 randomized clinical trial demonstrate that in patients with advanced heart failure who have classical indications for antiplatelet therapy use at the time of LVAD implantation, aspirin avoidance was safe and not associated with increased thrombosis risk. Importantly, elimination of aspirin was associated with no increased thrombosis but a reduction in nonsurgical bleeding events in patients with a history of PCI, CABG, stroke, or PVD.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration<\/jats:title><jats:p>ClinicalTrials.gov Identifier: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT04069156\">NCT04069156<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1001\/jamacardio.2024.4849","type":"journal-article","created":{"date-parts":[[2025,1,8]],"date-time":"2025-01-08T16:01:19Z","timestamp":1736352079000},"page":"235","source":"Crossref","is-referenced-by-count":26,"title":["Aspirin and Hemocompatibility After LVAD Implantation in Patients With Atherosclerotic Vascular Disease"],"prefix":"10.1001","volume":"10","author":[{"given":"Finn","family":"Gustafsson","sequence":"first","affiliation":[{"name":"Rigshospitalet, University of Copenhagen, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nir","family":"Uriel","sequence":"additional","affiliation":[{"name":"Columbia University College of Physicians and Surgeons and New York Presbyterian Hospital, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivan","family":"Netuka","sequence":"additional","affiliation":[{"name":"Insitute for Clinical and Experimental Medicine, Prague, Czech Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason N.","family":"Katz","sequence":"additional","affiliation":[{"name":"NYU Grossman School of Medicine and Bellevue Hospital, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francis D.","family":"Pagani","sequence":"additional","affiliation":[{"name":"University of Michigan, Ann Arbor"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean M.","family":"Connors","sequence":"additional","affiliation":[{"name":"Brigham and Women\u2019s Hospital and Harvard Medical School, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ulrich P.","family":"Jorde","sequence":"additional","affiliation":[{"name":"Montefiore Einstein Center for Heart and Vascular Care, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Zimpfer","sequence":"additional","affiliation":[{"name":"Medical University of Vienna, Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuriy","family":"Pya","sequence":"additional","affiliation":[{"name":"University Medical Center, Astana, Kazakhstan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer","family":"Conway","sequence":"additional","affiliation":[{"name":"University of Alberta Hospital, Edmonton, Alberta, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anelechi","family":"Anyanwu","sequence":"additional","affiliation":[{"name":"Mount Sinai Medical Center, New York, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna Mara","family":"Scandroglio","sequence":"additional","affiliation":[{"name":"Ospedale San Raffaele, Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nasir","family":"Sulemanjee","sequence":"additional","affiliation":[{"name":"Aurora St Luke\u2019s Medical Center, Milwaukee, Wisconsin"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pavan","family":"Atluri","sequence":"additional","affiliation":[{"name":"Hospital of the University of Pennsylvania, Philadelphia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary","family":"Keebler","sequence":"additional","affiliation":[{"name":"University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Craig H.","family":"Selzman","sequence":"additional","affiliation":[{"name":"University of Utah Hospital, Salt Lake City"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey D.","family":"Alexis","sequence":"additional","affiliation":[{"name":"University of Rochester Medical Center, Rochester, New York"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Hayward","sequence":"additional","affiliation":[{"name":"St Vincent\u2019s Hospital, Sydney, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Henderson","sequence":"additional","affiliation":[{"name":"Abbott, Chicago, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicholas","family":"Dirckx","sequence":"additional","affiliation":[{"name":"Abbott, Chicago, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlo","family":"Gazzola","sequence":"additional","affiliation":[{"name":"Abbott, Chicago, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mandeep R.","family":"Mehra","sequence":"additional","affiliation":[{"name":"Brigham and Women\u2019s Hospital Heart and Vascular Center, Center for Advanced Heart Disease, Harvard Medical School, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"ARIES Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","reference":[{"issue":"7","key":"hoi240082r1","doi-asserted-by":"publisher","first-page":"e364","DOI":"10.1161\/STR.0000000000000375","article-title":"2021 Guideline for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline from the American Heart Association\/American Stroke Association.","volume":"52","author":"Kleindorfer","year":"2021","journal-title":"Stroke"},{"issue":"3","key":"hoi240082r2","doi-asserted-by":"publisher","first-page":"407","DOI":"10.1093\/eurheartj\/ehz425","article-title":"2019 ESC guidelines for the diagnosis and management of chronic coronary syndromes.","volume":"41","author":"Knuuti","year":"2020","journal-title":"Eur Heart J"},{"issue":"9","key":"hoi240082r3","doi-asserted-by":"publisher","first-page":"763","DOI":"10.1093\/eurheartj\/ehx095","article-title":"2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European Society for Vascular Surgery (ESVS): document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries Endorsed by: the European Stroke Organization (ESO)the task force for the diagnosis and treatment of peripheral arterial diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS).","volume":"39","author":"Aboyans","year":"2018","journal-title":"Eur Heart J"},{"issue":"25","key":"hoi240082r4","doi-asserted-by":"publisher","first-page":"e344","DOI":"10.1161\/CIR.0000000000000134","article-title":"2014 AHA\/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: a report of the American College of Cardiology\/American Heart Association task force on practice guidelines.","volume":"130","author":"Amsterdam","year":"2014","journal-title":"Circulation"},{"issue":"38","key":"hoi240082r5","doi-asserted-by":"publisher","first-page":"3720","DOI":"10.1093\/eurheartj\/ehad191","article-title":"2023 ESC guidelines for the management of acute coronary syndromes.","volume":"44","author":"Byrne","year":"2023","journal-title":"Eur Heart J"},{"issue":"2","key":"hoi240082r6","doi-asserted-by":"publisher","first-page":"e21","DOI":"10.1016\/j.jacc.2021.09.006","article-title":"2021 ACC\/AHA\/SCAI guideline for coronary artery revascularization: a report of the American College of Cardiology\/American Heart Association Joint Committee on clinical practice guidelines.","volume":"79","author":"Lawton","year":"2022","journal-title":"J Am Coll Cardiol"},{"issue":"12","key":"hoi240082r7","doi-asserted-by":"publisher","DOI":"10.1161\/JAHA.118.009237","article-title":"Characteristics and treatments of patients enrolled in the CHAMP-HF Registry compared with patients enrolled in the PARADIGM-HF trial.","volume":"7","author":"DeVore","year":"2018","journal-title":"J Am Heart Assoc"},{"issue":"2","key":"hoi240082r8","doi-asserted-by":"publisher","first-page":"156","DOI":"10.1016\/j.jchf.2017.09.021","article-title":"Low-dose aspirin in heart failure not complicated by atrial fibrillation: a nationwide propensity-matched study.","volume":"6","author":"Madelaire","year":"2018","journal-title":"JACC Heart Fail"},{"issue":"9","key":"hoi240082r9","doi-asserted-by":"publisher","first-page":"1648","DOI":"10.1002\/ejhf.2971","article-title":"Real-world use of sodium-glucose cotransporter 2 inhibitors in patients with heart failure and reduced ejection fraction: data from the Swedish Heart Failure Registry.","volume":"25","author":"Stolfo","year":"2023","journal-title":"Eur J Heart Fail"},{"issue":"1","key":"hoi240082r10","doi-asserted-by":"publisher","first-page":"4","DOI":"10.1002\/ejhf.2333","article-title":"2021 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure: developed by the task force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC) with the special contribution of the Heart Failure Association (HFA) of the ESC.","volume":"24","author":"McDonagh","year":"2022","journal-title":"Eur J Heart Fail"},{"issue":"17","key":"hoi240082r11","doi-asserted-by":"publisher","first-page":"e263","DOI":"10.1016\/j.jacc.2021.12.012","article-title":"2022 AHA\/ACC\/HFSA guideline for the management of heart failure: a report of the American College of Cardiology\/American Heart Association Joint Committee on clinical practice guidelines.","volume":"79","author":"Heidenreich","year":"2022","journal-title":"J Am Coll Cardiol"},{"issue":"8","key":"hoi240082r12","doi-asserted-by":"publisher","first-page":"1392","DOI":"10.1002\/ejhf.2211","article-title":"Primary results of long-term outcomes in the MOMENTUM 3 pivotal trial and continued access protocol study phase: a study of 2200 HeartMate 3 left ventricular assist device implants.","volume":"23","author":"Mehra","year":"2021","journal-title":"Eur J Heart Fail"},{"issue":"12","key":"hoi240082r13","doi-asserted-by":"publisher","first-page":"1233","DOI":"10.1001\/jama.2022.16197","article-title":"Five-year outcomes in patients with fully magnetically levitated vs axial-flow left ventricular assist devices in the MOMENTUM 3 randomized trial.","volume":"328","author":"Mehra","year":"2022","journal-title":"JAMA"},{"issue":"8","key":"hoi240082r14","doi-asserted-by":"publisher","first-page":"613","DOI":"10.1093\/eurheartj\/ehad658","article-title":"Fully magnetically centrifugal left ventricular assist device and long-term outcomes: the ELEVATE registry.","volume":"45","author":"Schmitto","year":"2024","journal-title":"Eur Heart J"},{"issue":"1","key":"hoi240082r15","doi-asserted-by":"publisher","first-page":"33","DOI":"10.1016\/j.athoracsur.2023.11.004","article-title":"The Society of Thoracic Surgeons Intermacs 2023 annual report: focus on magnetically levitated devices.","volume":"117","author":"Jorde","year":"2024","journal-title":"Ann Thorac Surg"},{"issue":"8","key":"hoi240082r16","doi-asserted-by":"publisher","first-page":"806","DOI":"10.1016\/j.healun.2019.05.006","article-title":"Effects of a fully magnetically levitated centrifugal-flow or axial-flow left ventricular assist device on von Willebrand factor: a prospective multicenter clinical trial.","volume":"38","author":"Bansal","year":"2019","journal-title":"J Heart Lung Transplant"},{"issue":"23","key":"hoi240082r17","doi-asserted-by":"publisher","first-page":"2162","DOI":"10.1016\/j.jacc.2009.02.048","article-title":"Severely impaired von Willebrand factor-dependent platelet aggregation in patients with a continuous-flow left ventricular assist device (HeartMate II).","volume":"53","author":"Klovaite","year":"2009","journal-title":"J Am Coll Cardiol"},{"issue":"22","key":"hoi240082r18","doi-asserted-by":"publisher","first-page":"2171","DOI":"10.1001\/jama.2023.23204","article-title":"Aspirin and hemocompatibility events with a left ventricular assist device in advanced heart failure: the ARIES-HM3 randomized clinical trial.","volume":"330","author":"Mehra","year":"2023","journal-title":"JAMA"},{"issue":"7","key":"hoi240082r19","doi-asserted-by":"publisher","first-page":"1226","DOI":"10.1002\/ejhf.2275","article-title":"Aspirin and left ventricular assist devices rationale and design for the international randomized, placebo-controlled, noninferiority ARIES HM3 Trial.","volume":"23","author":"Mehra","year":"2022","journal-title":"Eur J Heart Fail"},{"issue":"8","key":"hoi240082r20","doi-asserted-by":"publisher","first-page":"735","DOI":"10.1016\/j.healun.2020.03.010","article-title":"Updated definitions of adverse events for trials and registries of mechanical circulatory support: a consensus statement of the mechanical circulatory support academic research consortium.","volume":"39","author":"Kormos","year":"2020","journal-title":"J Heart Lung Transplant"},{"issue":"15","key":"hoi240082r21","doi-asserted-by":"publisher","first-page":"1465","DOI":"10.1056\/NEJMc1401768","article-title":"Increase in left ventricular assist device thrombosis.","volume":"370","author":"Starling","year":"2014","journal-title":"N Engl J Med"},{"issue":"16","key":"hoi240082r22","doi-asserted-by":"publisher","first-page":"1513","DOI":"10.1056\/NEJMoa1708454","article-title":"Dual antithrombotic therapy with dabigatran after PCI in atrial fibrillation.","volume":"377","author":"Cannon","year":"2017","journal-title":"N Engl J Med"},{"issue":"12","key":"hoi240082r23","doi-asserted-by":"publisher","first-page":"1103","DOI":"10.1056\/NEJMoa1904143","article-title":"Antithrombotic therapy for atrial fibrillation with stable coronary disease.","volume":"381","author":"Yasuda","year":"2019","journal-title":"N Engl J Med"},{"issue":"4","key":"hoi240082r24","doi-asserted-by":"publisher","first-page":"604","DOI":"10.1016\/j.healun.2023.11.016","article-title":"Gastrointestinal bleeding following Heartmate 3 left ventricular assist device implantation: the Michigan Bleeding Risk Model.","volume":"43","author":"Hammer","year":"2024","journal-title":"J Heart Lung Transplant"},{"issue":"6","key":"hoi240082r25","doi-asserted-by":"publisher","first-page":"509","DOI":"10.1161\/CIRCULATIONAHA.124.069726","article-title":"A Prospective randomized trial of direct oral anticoagulant therapy with a fully magnetically levitated LVAD: the DOT-HM3 study.","volume":"150","author":"Netuka","year":"2024","journal-title":"Circulation"},{"issue":"9","key":"hoi240082r26","doi-asserted-by":"publisher","first-page":"1540","DOI":"10.1016\/j.jchf.2024.04.013","article-title":"Evaluation of the hemocompatibility of the direct oral anticoagulant apixaban in left ventricular assist devices: the DOAC LVAD study.","volume":"12","author":"Shah","year":"2024","journal-title":"JACC Heart Fail"}],"container-title":["JAMA Cardiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jamacardiology\/articlepdf\/2828598\/jamacardiology_gustafsson_2025_oi_240082_1744999813.92115.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,23]],"date-time":"2025-04-23T15:00:25Z","timestamp":1745420425000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jamacardiology\/fullarticle\/2828598"}},"subtitle":["A Secondary Analysis From the ARIES-HM3 Randomized Clinical Trial"],"short-title":[],"issued":{"date-parts":[[2025,3,1]]},"references-count":26,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2025,3,1]]}},"URL":"https:\/\/doi.org\/10.1001\/jamacardio.2024.4849","relation":{},"ISSN":["2380-6583"],"issn-type":[{"value":"2380-6583","type":"print"}],"subject":[],"published":{"date-parts":[[2025,3,1]]}}}