Evidence map›Paper›PMID 32860406›Full record

Observational studyEuropean heart journal2020

The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction: the BAMI trial.

Anthony Mathur, Francisco Fernández-Avilés, Jozef Bartunek, Ann Belmans, Filippo Crea, Sheik Dowlut, Manuel Galiñanes, Marie-Claire Good, Juha Hartikainen, Christine Hauskeller and 9 more

Open access · bronzeAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in European heart journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 5 pooled it
6.3field-weighted citation impact, top 3% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 5 syntheses or guidelines pooled it, 70 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 15 institutions in 9 countries.

Anthony MathurCentre for Cardiovascular Medicine & Devices, Queen Mary University of London, London EC1M 6BQ, UK.
Francisco Fernández-AvilésHospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón, CIBERCV, Madrid, Spain.
Jozef BartunekCardiovascular Center, OLV Hospital Aalst, Aalst, Belgium.
Ann BelmansKU, Leuven, Leuven, Belgium.
Filippo CreaCatholic University of the Sacred Heart, Rome, Italy.
Sheik DowlutCentre for Cardiovascular Medicine & Devices, Queen Mary University of London, London EC1M 6BQ, UK.
Manuel GaliñanesDepartment of Cardiac Surgery, Reparative Therapy of the Heart, Vall d'Hebron Research Institute, University Hospital Vall d'Hebron, Autonomous University of Barcelona, Barcelona, Spain.
Marie-Claire GoodQueen Mary University of London, London, UK.
Juha HartikainenKuopio University Hospital, Kuopio, Finland.
Christine HauskellerUniversity of Exeter, Exeter, UK.
Stefan JanssensUniversity Hospitals (UZ) Leuven, Belgium.
Petr KalaUniversity Hospital Brno and Medical Faculty of Masaryk University, Brno, Czech Republic.
Jens KastrupRigshospitalet and University of Copenhagen, Denmark.
John MartinUniversity College London, London, UK.
Philippe MenaschéDepartment of Cardiovascular Surgery, Hôpital Européen Georges Pompidou and University of Paris, Paris, France.
Ricardo Sanz-RuizHospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón, CIBERCV, Madrid, Spain.
Seppo Ylä-HerttualaUniversity of Eastern Finland, Finland.
Andreas ZeiherDepartment of Medicine III, Goethe University of Frankfurt, Frankfurt, Germany.
BAMI Group
Queen Mary University of London · GBHospital General Universitario Gregorio Marañón · ESGoethe University Frankfurt · DEHôpital Européen Georges-Pompidou · FRKU Leuven · BEKuopio University Hospital · FIMasaryk University · CZOnze Lieve Vrouwziekenhuis Hospital · BEUniversità Cattolica del Sacro Cuore · ITUniversitair Ziekenhuis Leuven · BEUniversitat Autònoma de Barcelona · ESUniversity College London · GBUniversity of Copenhagen · DKUniversity of Eastern Finland · FIUniversity of Exeter · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsBone marrow-derived mononuclear cell (BM-MNC) therapy may improve myocardial recovery in patients following acute myocardial infarction (AMI), though existing trial results are inconsistent. METHODS AND

resultsOriginally an open-label, multicentre Phase III trial, BAMI was designed to demonstrate the safety and efficacy of intracoronary infusion of BM-MNCs in reducing the time to all-cause mortality in patients with reduced left ventricular ejection fraction (LVEF, ≤45%) after primary angioplasty (PPCI) for ST-elevation AMI. Unexpectedly low recruitment means the trial no longer qualifies as a hypothesis-testing trial, but is instead an observational study with no definitive conclusions possible from statistical analysis. In total, 375 patients were recruited: 185 patients were randomized to the treatment arm (intracoronary infusion of BM-MNCs 2-8 days after PPCI) and 190 patients to the control arm (optimal medical therapy). All-cause mortality at 2 years was 3.26% [6 deaths; 95% confidence interval (CI): 1.48-7.12%] in the BM-MNC group and 3.82% (7 deaths; 95% CI: 1.84-7.84%) in the control group. Five patients (2.7%, 95% CI: 1.0-5.9%) in the BM-MNC group and 15 patients (8.1%, CI : 4.7-12.5%) in the control group were hospitalized for heart failure during 2 years of follow-up. Neither adverse events nor serious adverse events differed between the two groups. There were no patients hospitalized for stroke in the control group and 4 (2.2%) patients hospitalized for stroke in the BM-MNC group.

conclusionsAlthough BAMI is the largest trial of autologous cell-based therapy in the treatment of AMI, unexpectedly low recruitment and event rates preclude any meaningful group comparisons and interpretation of the observed results.

Indexed as

Myocardial InfarctionVentricular Function, LeftBone MarrowBone Marrow TransplantationClinical Trials, Phase III as TopicHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicStroke VolumeTransplantation, AutologousTreatment OutcomeBone marrow cellsCell- and tissue-based therapyST-elevation myocardial infarction

Identifiers

PMID32860406
PMCPMC7666866
OpenAlexW3082263169

What OpenQuestion holds

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Registered trials

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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.