Evidence map›Paper›PMID 33405291›Full record

ArticleClinical cardiology2021

Restrictive vs liberal red blood cell transfusion strategies in patients with acute myocardial infarction and anemia: Rationale and design of the REALITY trial.

Gregory Ducrocq, Gonzalo Calvo, José Ramón González-Juanatey, Isabelle Durand-Zaleski, Cristina Avendano-Sola, Etienne Puymirat, Gilles Lemesle, Joan Albert Arnaiz, Manuel Martínez-Sellés, Alexandra Rousseau and 8 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical cardiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02648113 (Cost-effectiveness and Cost-utility of Liberal vs Restrictive Red Blood Cell Transfusion Strategies in Patients With Acute Myocardial Infarction and Anaemia. The REALITY), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.3field-weighted citation impact, top 20% 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.

NCT02648113 nacompletednot on this map

Cost-effectiveness and Cost-utility of Liberal vs Restrictive Red Blood Cell Transfusion Strategies in Patients With Acute Myocardial Infarction and Anaemia. The REALITY (REstrictive And LIberal Transfusion Strategies in Patients With Acute mYocardial Infarction) Randomized Trial.

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2016 to 2020Enrolled668ConditionsMyocardial Infarction, Anemia, Blood TransfusionArmsRestrictive transfusion, Liberal transfusion, red blood transfusion
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 11 citations in OpenAlex.

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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

18 authors at 9 institutions in 3 countries.

Gregory DucrocqUniversité de Paris, AP-HP, French Alliance for Cardiovascular Trials (FACT), INSERM U1148, Paris, France.ORCID https://orcid.org/0000-0003-4069-1128
Gonzalo CalvoÀrea del Medicament Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain.
José Ramón González-JuanateyCardiology Department, University Hospital, IDIS, CIBERCV, University of Santiago de Compostela, Santiago de Compostela, Spain.
Isabelle Durand-ZaleskiAP-HP Health Economics Research Unit, Hotel Dieu Hospital, INSERM UMR 1153 CRESS, Paris, France.
Cristina Avendano-SolaClinical Pharmacology Service, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.
Etienne PuymiratHôpital Européen Georges Pompidou, AP-HP, French Alliance for Cardiovascular Trials (FACT), and Université de Paris, Paris, France.ORCID https://orcid.org/0000-0002-0533-9682
Gilles LemesleInstitut Cœur Poumon, Centre Hospitalier Universitaire de Lille, Faculté de Médecine de Lille, Université de Lille, Institut Pasteur de Lille, Inserm U1011, F-59000 Lille, France; French Alliance for Cardiovascular Trials (FACT), Paris, France.ORCID https://orcid.org/0000-0002-2917-9273
Joan Albert ArnaizClinical Trials Unit, Clinical Pharmacology Department, Hospital Clinic, Barcelona, Spain.
Manuel Martínez-SellésServicio de Cardiología, Hospital Universitario Gregorio Marañón, CIBERCV; Universidad Europea, Universidad Complutense, Madrid, Spain.ORCID https://orcid.org/0000-0003-0289-6229
Alexandra RousseauClinical Research Platform (URCEST-CRB-CRCEST), AP-HP, Hôpital Saint Antoine, Paris, France.
Marine CachanadoClinical Research Platform (URCEST-CRB-CRCEST), AP-HP, Hôpital Saint Antoine, Paris, France.
Eric VicautAP-HP, Department of Biostatistics, Université Paris-Diderot, Sorbonne-Paris Cité, Fernand Widal Hospital, France.
Johanne SilvainSorbonne Université, ACTION Study Group, Institut de Cardiologie, Hôpital Pitié-Salpêtrière, AP-HP, INSERM UMRS 1166, Paris, France.
Carma KaramCardiology Department, Ambroise Paré Hospital, AP-HP, Boulogne, University of Versailles-Saint Quentin en Yvelines, Boulogne-Billancourt, France.
Nicolas DanchinHôpital Européen Georges Pompidou, AP-HP, French Alliance for Cardiovascular Trials (FACT), and Université de Paris, Paris, France.
Tabassome SimonDepartment of Clinical Pharmacology-Clinical Research Platform (URCEST-CRB-CRCEST), AP-HP, Hôpital Saint Antoine, French Alliance for Cardiovascular Trials (FACT), Sorbonne-Université, Paris, France.
Philippe Gabriel StegUniversité de Paris, AP-HP, French Alliance for Cardiovascular Trials (FACT), INSERM U1148, Paris, France.ORCID https://orcid.org/0000-0001-6896-2941
REALITY investigators
Inserm · FRSorbonne Université · FRUniversité Paris Cité · FRHôpital Ambroise-Paré · FRHospital Clínic de Barcelona · ESHospital General Universitario Gregorio Marañón · ESHospital Universitario Puerta de Hierro Majadahonda · ESUniversidade de Santiago de Compostela · ESUniversitat de Barcelona · ES

Funding

Instituto de Salud Carlos IIIProgramme de Recherche Médico-Economique (PRME)
6 · The paper itself

Abstract

backgroundAnemia is common in patients with acute myocardial infarction (AMI), and is an independent predictor of mortality. The optimal transfusion strategy in these patients is unclear. HYPOTHESIS: We hypothesized that a "restrictive" transfusion strategy (triggered by hemoglobin ≤8 g/dL) is clinically noninferior to a "liberal" transfusion strategy (triggered by hemoglobin ≤10 g/dL), but is less costly.

methodsREALITY is an international, randomized, multicenter, open-label trial comparing a restrictive vs a liberal transfusion strategy in patients with AMI and anemia. The primary outcome is the incremental cost-effectiveness ratio (ICER) at 30 days, using the primary composite clinical outcome of major adverse cardiovascular events (MACE; comprising all-cause death, nonfatal stroke, nonfatal recurrent myocardial infarction, or emergency revascularization prompted by ischemia) as the effectiveness criterion. Secondary outcomes include the ICER at 1 year, and MACE (and its components) at 30 days and at 1 year.

resultsThe trial aimed to enroll 630 patients. Based on estimated event rates of 11% in the restrictive group and 15% in the liberal group, this number will provide 80% power to demonstrate clinical noninferiority of the restrictive group, with a noninferiority margin corresponding to a relative risk equal to 1.25. The sample size will also provide 80% power to show the cost-effectiveness of the restrictive strategy at a threshold of €50 000 per quality-adjusted life year.

conclusionsREALITY will provide important guidance on the management of patients with AMI and anemia.

Indexed as

AnemiaMyocardial InfarctionBlood TransfusionErythrocyte TransfusionHemoglobinsHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicHemoglobinsacute myocardial infarctionanemiacost effectivenesstransfusion

Identifiers

PMID33405291
PMCPMC7852166
OpenAlexW3118339700

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.