REALITY Trial – Liberal Vs Restrictive Transfusion in MI
Dr Swapnil Pawar
Blog is written by Dr Jose Chacko
Setting and design
The study conducted in 26 centres in France and 9 centres in Spain
Enrolment between March 2016 to September 2019
Patients assigned a 1:1 ratio to the restrictive or a liberal transfusion arm. Web-based, centralized randomization, with blocks of varying size and stratified by centre.
MACE assumed to be 11% in the restrictive transfusion group and 15% in the liberal transfusion group. A sample size of 300 patients per group for 80% power to demonstrate noninferiority.
STEMI or NSTEMI with a combination of symptoms of cardiac ischemia and elevated biomarkers within 48 hours before admission
Cardiogenic shock (systolic blood pressure <90 mm Hg, clinical signs of low output or requirement for inotropic drugs)
Myocardial infarction following the percutaneous coronary intervention or coronary artery bypass surgery
Massive, ongoing or life-threatening or massive ongoing bleeding as judged by the clinician
Blood transfusion in the past 30 days
Transfusion if Hb 8 g/dL or lower, with a target range of 8 to 10 g/dL
Transfusion if Hb 10 g/dL or lower, with target hemoglobin of at least 11 g/dL
The assigned transfusion strategy was maintained until hospital discharge or until 30 days after randomization, whichever occurred first. Transfusion allowed at any time in case of:
Patients were followed up at day 30 (±5 days)
Angiography: 81.9% vs. 79.3% in the liberal group; approximately two-thirds underwent myocardial revascularization.
(If the confidence interval contains the relative risk of 1.00, the result is not significant, or in other words, there is no superiority)
Primary outcome: Major adverse cardiovascular event (all-cause mortality, nonfatal stroke, nonfatal recurrent myocardial infarction, or emergency revascularization prompted by ischemia)
Restrictive (342) Liberal (324)
In the planned sequential superiority analysis performed among the as-randomized population, the restrictive strategy did not meet the criteria for superiority compared with the liberal strategy.
Subgroup analyses based on age; sex; body weight; smoking status; Killip class; kidney function (creatinine clearance); type of myocardial infarction (ST- vs non– ST-segment elevation myocardial infarction); presence or absence of diabetes, hypertension, dyslipidemia, and active bleeding; and hemoglobin levels at the time of randomization yielded results consistent with the main analysis, and results of the tests for interaction were not statistically significant
Secondary outcomes: Nil statistically significant difference between the two groups
Individual components of MACE at 30 days
(for all-cause mortality at 30 d)
Recurrent myocardial infarction
Adverse events monitored during hospital stay:
80% had revascularization – would a higher Hb be required in patients who do not undergo revascularization?
Non-inferiority study; couldn’t prove the superiority of a restrictive transfusion strategy
Not powered to demonstrate superiority
Results do not apply to patients in cardiogenic shock
Is a target of 11 gm/dl the standard of care?
Long term results not available (current results are only for 30 days)
OUR Recommendation –
Individualised approach rather than practising dogmatic targets for transfusion in patients with Myocardial infarction.