REALITY trial supports restrictive blood transfusion strategy in patients with MI, anemia
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In patients with anemia who present with MI, a restrictive blood transfusion strategy was noninferior to liberal transfusion for preventing major adverse CV events at 30 days, according to results of the REALITY trial.
This was an academic trial conducted in France and Spain.
Moreover, the restrictive strategy saved blood, was safe and may be cost effective in this patient population, P. Gabriel Steg, MD, director of the cardiology department at Hôpital Bichat, Paris, and professor of cardiology at the Université de Paris, reported at the virtual European Society of Cardiology Congress.
“A restrictive strategy has several advantages,” Steg told Healio. “It saves money and it saves blood, and we have good evidence that it is noninferior clinically.”
Prior to the REALITY trial, there was uncertainty to which transfusion strategy is best in patients with anemia and MI. Randomized controlled trials have compared restrictive and liberal transfusion strategies in cardiac and non-cardiac surgery or in patients with gastrointestinal bleeding, but patients with acute MI were excluded, he said. Further, the two previous small randomized trials in patients with MI “found exactly opposite results, so the clinician today is left without evidence and without guidance about what to do” in this patient population, he said in an interview.
The randomized REALITY trial included 668 patients with acute MI and a hemoglobin of 7 g/dL to to 10 g/dL at any time during hospital admission.
Patients were assigned a liberal red blood cell transfusion strategy (n = 324; median age, 76 years; 57% men) or a restrictive red blood cell transfusion strategy (n = 342; median age, 78 years; 59% men). The liberal strategy was triggered in patients when hemoglobin was 10 g/dL or less, with a target greater than 11 g/dL; the restrictive strategy was triggered when hemoglobin was 8 g/dL or less, with a target between 8 g/dL and 10 g/dL.
Steg told Healio that there were 55% fewer units of blood used in the restrictive-strategy group compared with the liberal-strategy group.
In the per-protocol population, the primary clinical outcome of MACE at 30 days, defined as reinfarction, stroke, death or emergency revascularization for ischemia, occurred in 11% of the restrictive-strategy group vs. 14% of the liberal-strategy group (difference, 3%; 95% CI, 8.4 to 2.4; RR = 0.79; one-sided 97.5% CI, 1.18).
“Noninferiority was verified in both the per-protocol and the intention-to-treat population,” Steg said during a press conference.
Most safety endpoints did not differ between the two strategies, although there were significant reductions with the restrictive strategy for infection (0% vs. 1.5%, difference, 1.5%; 95% CI, 3.2 to 0.1, P = .03) and acute lung injury (0.3% vs. 2.2%; difference, 1.9%; 95% CI, 3.9 to 0.1; P = .03), according to the results.
The French and Spanish researchers also performed a cost-effectiveness analysis at 30 days. The cost-effectiveness analysis determined that the restrictive strategy had an 84% probability of being dominant, “both saving money and improving outcomes,” Steg said during the press conference.
Speaking with Healio, Steg emphasized careful decision-making about the optimal strategy for patients with anemia and MI.
“The hemoglobin value is only one of many factors that decide on whether to use a transfusion in these patients,” Steg said. “We excluded patients who had active massive bleeding or impending shock, and that can happen in this fragile population with many comorbidities. The tolerance and the speed of appearance of anemia are also factors that need to be taken into account when deciding on a transfusion, but if the patient is stable, a restrictive strategy is quite attractive from various standpoints.”
Further research is underway to assess the benefits of a restrictive transfusion strategy in this patient population. The ongoing, randomized MINT trial is currently enrolling and will test whether the restrictive strategy is superior to the liberal strategy. This trial has a similar design to REALITY, but will be larger, according to Steg, who anticipates that the upcoming trial “will provide a definitive answer on these clinical grounds.”
In a discussion of the REALITY trial, Marco Roffi, MD, FACC, FESC, full professor of cardiology, vice chairman of cardiology and director of the interventional cardiology unit at the University Hospital of Geneva in Switzerland, discussed how the REALITY trial findings might impact the new ESC guideline on non-ST segment elevation ACS that was just released.
“The newly released guidelines tell us that, based on inconsistent results and the lack of adequately randomized trials, a restrictive policy of transfusion in an anemic patient with MI may be considered. We can say with confidence that, following REALITY, a restrictive policy of transfusion in an anemic patient with MI should be considered,” Roffi said.
Editor's Note: This article was modified on September 2, 2020 to reflect an update to the data.
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Steg PG, et al. Hot Line: REALITY. Presented at: European Society of Cardiology Congress; Aug. 29-Sept. 1, 2020 (virtual meeting).
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