Evidence map›Paper›PMID 32340871›Full record

Trial reportThe Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation2020

Effect of aspirin dose on hemocompatibility-related outcomes with a magnetically levitated left ventricular assist device: An analysis from the MOMENTUM 3 study.

Omar Saeed, Paolo C Colombo, Mandeep R Mehra, Nir Uriel, Daniel J Goldstein, Joseph Cleveland, Jean M Connors, Samer S Najjar, Nahush A Mokadam, Aditya Bansal and 3 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02224755 (Thoratec Corporation MOMENTUM 3, Multi-center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ IDE Clinical Study Protocol), which is not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02224755 nacompletednot on this map

Thoratec Corporation MOMENTUM 3, Multi-center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ IDE Clinical Study Protocol

TypeinterventionalSponsorAbbott Medical DevicesRan2014 to 2019Enrolled1,028ConditionsAdvanced Refractory Left Ventricular Heart FailureArmsHeartMate 3 LVAS, HeartMate II LVAS
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 56 citations in OpenAlex.

  1. Pooled it
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  5. Observational
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  11. Review
  12. Conservative initial postoperative anticoagulation strategy after HeartMate 3 left ventricular assist device implantation.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2022
    Article
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  15. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 8 institutions in 1 country.

Omar SaeedDepartment of Medicine and Department of Cardiothoracic and Vascular Surgery, Montefiore-Einstein Center for Heart and Vascular Care, Bronx, New York.
Paolo C ColomboDepartment of Medicine, Columbia University Medical Center, New York, New York.
Mandeep R MehraDepartment of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.
Nir UrielDepartment of Medicine, Columbia University Medical Center, New York, New York.
Daniel J GoldsteinDepartment of Medicine and Department of Cardiothoracic and Vascular Surgery, Montefiore-Einstein Center for Heart and Vascular Care, Bronx, New York.
Joseph ClevelandDepartment of Surgery, University of Colorado Hospital, Aurora, Colorado.
Jean M ConnorsDepartment of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.
Samer S NajjarDepartment of Medicine, Medstar Washington Hospital Center, Washington, District of Columbia.
Nahush A MokadamDepartment of Surgery, Ohio State University, Columbus, Ohio.
Aditya BansalDepartment of Surgery, Ochsner Medical Center, New Orleans, Louisiana.
Daniel L CrandallDivision of Cardiology Department of Medicine, Abbott, Chicago, Illinois.
Poornima SoodDivision of Cardiology Department of Medicine, Abbott, Chicago, Illinois.
Ulrich P JordeDepartment of Medicine and Department of Cardiothoracic and Vascular Surgery, Montefiore-Einstein Center for Heart and Vascular Care, Bronx, New York. Electronic address: ujorde@montefiore.org.
Albert Einstein College of Medicine · USAbbott (United States) · USBrigham and Women's Hospital · USColumbia University Irving Medical Center · USMedStar Washington Hospital Center · USOchsner Medical Center · USThe Ohio State University · USUniversity of Colorado Hospital · US

Funding

CTSA Administrative Supplement for Informatics Core: A novel AI/ML system to predict respiratory failure and ARDS in Covid-19 patientsUL1TR002556 · NCATS · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI KELLER, MARLA J, KIM, MIMI Y · 2018 to 2022
$26.7M
Core-010UL1TR001073 · NCATS · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI KELLER, MARLA J, SHAMOON, HARRY · 2013 to 2017
$21.3M
Hemolysis and Platelet Activation during Continuous Flow Mechanical Circulatory SupportK23HL145140 · NHLBI · ALBERT EINSTEIN COLLEGE OF MEDICINE · PI SAEED, OMAR · 2019 to 2023
$840k
NCATS NIH HHS UL1 TR001073NCATS NIH HHS UL1 TR002556NHLBI NIH HHS K23 HL145140
6 · The paper itself

Abstract

backgroundAspirin (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.

methodsIn 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.

resultsOverall, 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.

conclusionsUsual- 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.

Indexed as

Heart-Assist DevicesAdministration, OralAspirinDose-Response Relationship, DrugFemaleFollow-Up StudiesHeart FailureHumansMaleMiddle AgedPlatelet Aggregation InhibitorsProspective StudiesThrombosisTreatment OutcomeAspirinPlatelet Aggregation Inhibitorsaspirinbleedinghemocompatibilityleft ventricular assist devicethrombosis

Identifiers

PMID32340871
PMCPMC7650304
OpenAlexW3012760521

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.