REALITY Trial: Transfusion in Patients With Myocardial Infarction and Anemia

REALITY Trial

Multiple small trials in the past have shown benefits of liberal transfusion strategy in patients having active MI. However, a large size trial was lacking. The REALITY trial was designed to answer this very questions,

Clinical Question:

The REALITY trial evaluated the safety and efficacy of a restrictive versus liberal red blood cell (RBC) transfusion strategy among patients with acute myocardial infarction (AMI) and anemia.

Bottom Line:

The trial showed similar outcomes for both restrictive and liberal strategy. A restrictive PRBC transfusion strategy (transfusion for Hgb ≤8 g/dl, goal 8-10 g/dl) was noted to be noninferior to a more liberal strategy (transfusion for Hgb ≤10 g/dl, goal Hgb >11 g/dl) in patients with acute myocardial infarction.

Trial Design:

Multicenter, randomized non inferiority clinical trial

Population:

In total, 666 patients were included and were randomized to liberal strategy of transfusion (for Hgb ≤10 g/dl, goal Hgb >11 g/dl) (n = 342) or restrictive strategy (for Hgb ≤8 g/dl, target Hgb 8-10 g/dl) (n = 324)

Inclusion Criteria:

  • Patients with MI (STEMI or NSTEMI), last ischemic symptoms <48 hours before admission, troponin elevation,
  • Patients with anemia: Hb ≤10g/dl but >7 g/dl, at any time of index hospitalization for MI.

Primary Outcomes:

  1. All-cause death, reinfarction, stroke, and emergency revascularization due to ischemia %

14% patients in the liberal group had primary endpoint event compared to 11% in the restrictive group. HR 0.77, 95% CI 0.50-1.18, p < 0.05 for noninferiority, P = 0.22 for superiority

Key Secondary Outcomes:

1. Acute renal failure

7.1% patients in the liberal group developed ARF compared to 9.7% in the restrictive group. P=0.24

2. Infections

1.5% patients in the liberal group developed infections compared to 0% in the restrictive group. p=0.03

Take Home Point:

Similar to other trials that showed restrictive transfusion in other condiditons such as sepsis (TRISS trial) or after cardiac surgery (TRICS III), the REALITY trial showed noninferiority of restritive transfusion in patients having active MI.

Presented by Dr. Philippe Gabriel Steg at the European Society of Cardiology Virtual Congress, September 1, 2020. Source