REALITY Trial – Liberal Vs Restrictive Transfusion in MI

REALITY Trial 

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.

Population

Inclusion

STEMI or NSTEMI with a combination of symptoms of cardiac ischemia and elevated biomarkers within 48 hours before admission

Exclusion

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

Hematological malignancy

Intervention group

Transfusion if Hb 8 g/dL or lower, with a target range of 8 to 10 g/dL

Control group

Transfusion if Hb 10 g/dL or lower, with target hemoglobin of at least 11 g/dL

Common care

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:

• Massive overt active bleeding
• Presumed significant decrease in Hb level requiring urgent transfusion (massive bleeding suspected)
• Shock, presumed to be due to hemorrhage

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.

Findings   

(If the confidence interval contains the relative risk of 1.00, the result is not significant, or in other words, there is no superiority)

Outcomes

Primary outcome: Major adverse cardiovascular event (all-cause mortality, nonfatal stroke, nonfatal recurrent myocardial infarction, or emergency revascularization prompted by ischemia)

(Non-inferior)

                                                         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   

All-cause mortality  

(for all-cause mortality at 30 d)

Stroke  

Recurrent myocardial infarction  

Emergency revascularization

Adverse events monitored during hospital stay:     

Comments

80% had revascularization – would a higher Hb be required in patients who do not undergo revascularization?

Unblinded study

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.