Evidence map›Paper›PMID 34142415›Full record

ReviewEuropean journal of heart failure2021

Aspirin and left ventricular assist devices: rationale and design for the international randomized, placebo-controlled, non-inferiority ARIES HM3 trial.

Mandeep R Mehra, Daniel L Crandall, Finn Gustafsson, Ulrich P Jorde, Jason N Katz, Ivan Netuka, Nir Uriel, Jean M Connors, Poornima Sood, Gerald Heatley and 1 more

Registry-linked trialOpen access · hybridAbstract readReview
In one paragraph

Review in European journal of heart failure, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04069156 (Antiplatelet Removal and HemocompatIbility EventS With the HeartMate 3 Pump IDE Study), which is not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
5.0field-weighted citation impact, top 4% 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.

NCT04069156 nacompletednot on this map

Antiplatelet Removal and HemocompatIbility EventS With the HeartMate 3 Pump IDE Study

TypeinterventionalSponsorAbbott Medical DevicesRan2020 to 2023Enrolled628ConditionsHeart FailureArmsLVAD Implant, Aspirin 100mg, Placebo oral tablet
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 68 citations in OpenAlex.

  1. Pooled it
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  16. Left Ventricular Assist Devices: A Primer For the General Cardiologist.Journal of the American Heart Association · 2022
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 8 institutions in 3 countries.

Mandeep R MehraDepartment of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
Daniel L CrandallClinical Affairs Heart Failure, Abbott, Chicago, IL, USA.
Finn GustafssonCardiology, Rigshospitalet, Copenhagen, Denmark.
Ulrich P JordeEinstein Center for Heart and Vascular Care, Montefiore Medical Center, Bronx, NY, USA.
Jason N KatzDivision of Cardiology, Duke University, Durham, NC, USA.
Ivan NetukaDepartment of Cardiovascular Surgery, IKEM, Prague, Czech Republic.
Nir UrielHeart Failure, Heart Transplant & Mechanical Circulatory Support, Columbia University Medical Center, New York, NY, USA.
Jean M ConnorsDivision of Hematology, Brigham and Women's Hospital, Boston, MA, USA.
Poornima SoodClinical Affairs Heart Failure, Abbott, Chicago, IL, USA.
Gerald HeatleyGlobal Biometrics, Abbott, Chicago, IL, USA.
Francis D PaganiDepartment of Cardiac Surgery, University of Michigan, Ann Arbor, MI, USA.
Abbott (United States) · USBrigham and Women's Hospital · USColumbia University Irving Medical Center · USDuke University Hospital · USInstitute of Clinical and Experimental Medicine · CZMichigan Medicine · USMontefiore Medical Center · USRigshospitalet · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsOver decades, left ventricular assist device (LVAD) technology has transitioned from less durable bulky pumps to smaller continuous-flow pumps which have substantially improved long-term outcomes and quality of life. Contemporary LVAD therapy is beleaguered by haemocompatibility-related adverse events including thrombosis, stroke and bleeding. A fully magnetically levitated pump, the HeartMate 3 (HM3, Abbott, USA) LVAD, has been shown to be superior to the older HeartMate II (HMII, Abbott, USA) pump by improving haemocompatibility. Experience with the HM3 LVAD suggests near elimination of de-novo pump thrombosis, a marked reduction in stroke rates, and only a modest decrease in bleeding complications. Since the advent of continuous-flow LVAD therapy, patients have been prescribed a combination of aspirin and anticoagulation therapy on the presumption that platelet activation and perturbations to the haemostatic axis determine their necessity. Observational studies in patients implanted with the HM3 LVAD who suffer bleeding have suggested a signal of reduced subsequent bleeding events with withdrawal of aspirin. The notion of whether antiplatelet therapy can be avoided in an effort to reduce bleeding complications has now been advanced.

methodsTo evaluate this hypothesis and its clinical benefits, the Antiplatelet Removal and Hemocompatibility Events with the HeartMate 3 Pump (ARIES HM3) has been introduced as the first-ever international prospective, randomized, double-blind and placebo-controlled, non-inferiority trial in a patient population implanted with a LVAD.

conclusionThis paper reviews the biological and clinical role of aspirin (100 mg) with LVADs and discusses the rationale and design of the ARIES HM3 trial.

Indexed as

Heart-Assist DevicesHeart FailureAspirinHumansProspective StudiesQuality of LifeRandomized Controlled Trials as TopicAspirinAdvanced heart failureAspirinAssist devicesBleedingHemocompatibilityLVADMechanical Circulatory SupportOutcomes

Identifiers

PMID34142415
PMCPMC8361946
OpenAlexW3171479462

What OpenQuestion holds

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LicenceCC BY-NC
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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.