Ducrocq 2021.
| Study characteristics | ||
| Methods |
Design: RCT, open‐label, multicentre, international, non‐inferiority trial Setting: 35 hospitals in France and Spain Recruitment: March 2016 to September 2019 Maximum follow‐up: 30 days (investigators plan 12 month followup; results unpublished at the time of this update) |
|
| Participants | 666 participants with myocardial infarction within 48 hours of onset of symptoms, Hb between 7 g/dL and 10 g/dL, with healthcare insurance. Excluded were those with cardiogenic shock, post PCI or CABG, transfusion in previous 30 days, any known haematological disease, or massive bleeding
|
|
| Interventions |
|
|
| Outcomes |
Primary outcome: cost‐effectiveness Secondary outcome: the outcome of greatest clinical interest was MACE, defined as the composite of all cause 30‐day mortality, recurrent myocardial infarction, stroke, or emergency revascularisation for ischaemia |
|
| Notes |
Trial title: Effect of a Restrictive vs Liberal Blood Transfusion Strategy on Major Cardiovascular Events Among Patients With Acute Myocardial Infarction and Anemia: The REALITY Randomized Clinical Trial Trial registration: NCT02648113 Trial funding: "... the trial was designed by the French Alliance for Cardiovascular Trials and was funded via a grant from the Programme de Recherche Médico‐Economique (PRME) 2015 from the French Ministry of Health and a grant from the Instituto de Salud Carlos III (Spanish Ministry of Economy and Competitiveness: grant PI15/01543). There was no industry support. ... The funders and sponsor had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication" (Ducrocq 2021 p 559) COI statement by investigators: Dr. Danchin reported receiving personal fees from Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Intercept, MSD, Novo Nordisk, Pfizer, Sanofi, Servier, UCB, and Vifor outside the submitted work. Dr. Ducrocq reported receiving personal fees from Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Janssen, Sanofi, and Terumo outside the submitted work. Dr. Durand‐Zaleski reported receiving grants from the Ministry of Health during the conduct of the study and personal fees from Vifor outside the submitted work, and being the chair of the scientific committee of the French Blood Establishment. Dr. Lemesle reported receiving personal fees from Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Eli Lilly, MSD, Mylan, Novartis, Novo Nordisk, Pfizer, Sanofi Aventis, and Servier outside the submitted work. ... " (for further disclosures: see Ducrocq 2021 p 559) |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Centralized blocked randomization list will be prepared by the statisticians of the clinical research Unit (URC‐EST). The investigators at each site ...obtain[ed] the randomized strategy allocation using Internet (CleanWeb, Telemedecin Technologies, S.A.S). CleanWeb will assign the patient a unique randomization number that corresponds to one of the two transfusion strategies" |
| Allocation concealment (selection bias) | Low risk | Web‐based with varying block sizes |
| Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | Blinding of personnel for this intervention is not feasible, but in our view, for objective outcomes such as mortality (the primary outcome used within this review), we graded risk of bias as 'low' |
| Blinding of outcome assessment (detection bias) Objective measures | Low risk | Blinding of mortality (the primary outcome used within this review) is not relevant, and we graded risk of bias as 'low' "The choice of an open label design is justified by the difficulty in blinding the intervention (blood transfusion) and by the fact that the clinical outcomes are "hard" outcomes (mortality and non‐fatal major cardiac events) adjudicated by a critical event committee, blinded to randomization, and the Hb levels" (Ducrocq 2021, Supplement 1, p 19) |
| Blinding of outcome assessment (detection bias) Subjective measures | Low risk | No data from subjective outcomes (e.g. function) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 668 were randomised; 2 were excluded due to lack of consent/re‐consent; 666 were randomised with consent. All participants were included in as‐randomised analysis; 327/342 were included in as‐treated analysis for restrictive strategy arm; 322/324 were included in as‐treated analysis |
| Selective reporting (reporting bias) | Low risk | Trial was prospectively registered (NCT02648113), and both the protocol and the trial statistical analysis plan were made publicly available. No reporting bias was apparent |
| Other bias | Low risk | None detected |