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Economic evaluation of Restrictive Vs. Liberal Transfusion Strategy Following Acute Myocardial Infarction (REALITY): trial-based cost effectiveness and cost utility analyses
Durand-Zaleski I, Ducrocq G, Mimouni M, Frenkiel J, Avendano-Solá C, Gonzalez-Juanatey JR, Ferrari E, Lemesle G, Puymirat E, Berard L, et al
European heart journal. Quality of care & clinical outcomes. 2022
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Editor's Choice
Abstract
AIM: To estimate the cost effectiveness and cost utility ratios of a restrictive vs liberal transfusion strategy in acute myocardial infarction (AMI) patients with anemia. METHODS AND RESULTS Patients (n = 666) with AMI and hemoglobin between 7-8 and 10 g/dL recruited in 35 hospitals in France and Spain were randomly assigned to a restrictive (n = 342) or a liberal (n = 324) transfusion strategy with 1-year prospective collection of resource utilization and quality of life using the EQ5D3L questionnaire. The economic evaluation was based upon 648 patients from the per-protocol population. The outcomes were 30-day and 1-year cost-effectiveness, with major adverse cardiovascular event averted (MACE) as the effectiveness outcome; and 1-year cost utility ratio.The 30-day incremental cost-effectiveness ratio was €33,065€ saved per additional MACE averted with the restrictive versus the liberal strategy, with an 84% probability for the restrictive strategy to be cost-saving and MACE reducing (i.e.dominant). At 1-year, the point estimate of the cost-utility ratio was 191,500 € saved per QALY gained; however cumulated MACE were outside the pre-specified non-inferiority margin, resulting in a decremental cost effectiveness ratio with a point estimate of €72,000 saved per additional MACE with the restrictive strategy. CONCLUSION In patients with acute myocardial infarction and anemia, the restrictive transfusion strategy was dominant (cost-saving and outcome-improving) at 30 days. At 1 year, the restrictive strategy remained cost-saving but clinical noninferiority on MACE was no longer maintained. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02648113.
PICO Summary
Population
Acute myocardial infarction patients with anaemia, enrolled in the REALITY trial in 35 hospitals in France and Spain (n= 666).
Intervention
Restrictive transfusion strategy (n= 342).
Comparison
Liberal transfusion strategy (n= 324).
Outcome
The 30-day incremental cost-effectiveness ratio was €33,065 saved per additional major adverse cardiovascular event (MACE) averted with the restrictive versus the liberal strategy, with an 84% probability for the restrictive strategy to be cost-saving and MACE reducing. At 1-year, the point estimate of the cost-utility ratio was €191,500 saved per quality-adjusted life year gained; however cumulated MACE were outside the pre-specified non-inferiority margin, resulting in a decremental cost effectiveness ratio with a point estimate of €72,000 saved per additional MACE with the restrictive strategy.
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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
Ducrocq G, Gonzalez-Juanatey JR, Puymirat E, Lemesle G, Cachanado M, Durand-Zaleski I, Arnaiz JA, Martínez-Sellés M, Silvain J, Ariza-Solé A, et al
Jama. 2021;325(6):552-560
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Free full text
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Editor's Choice
Abstract
IMPORTANCE The optimal transfusion strategy in patients with acute myocardial infarction and anemia is unclear. OBJECTIVE To determine whether a restrictive transfusion strategy would be clinically noninferior to a liberal strategy. DESIGN, SETTING, AND PARTICIPANTS Open-label, noninferiority, randomized trial conducted in 35 hospitals in France and Spain including 668 patients with myocardial infarction and hemoglobin level between 7 and 10 g/dL. Enrollment could be considered at any time during the index admission for myocardial infarction. The first participant was enrolled in March 2016 and the last was enrolled in September 2019. The final 30-day follow-up was accrued in November 2019. INTERVENTIONS Patients were randomly assigned to undergo a restrictive (transfusion triggered by hemoglobin ≤8; n = 342) or a liberal (transfusion triggered by hemoglobin ≤10 g/dL; n = 324) transfusion strategy. MAIN OUTCOMES AND MEASURES The primary clinical outcome was major adverse cardiovascular events (MACE; composite of all-cause death, stroke, recurrent myocardial infarction, or emergency revascularization prompted by ischemia) at 30 days. Noninferiority required that the upper bound of the 1-sided 97.5% CI for the relative risk of the primary outcome be less than 1.25. The secondary outcomes included the individual components of the primary outcome. RESULTS Among 668 patients who were randomized, 666 patients (median [interquartile range] age, 77 [69-84] years; 281 [42.2%] women) completed the 30-day follow-up, including 342 in the restrictive transfusion group (122 [35.7%] received transfusion; 342 total units of packed red blood cells transfused) and 324 in the liberal transfusion group (323 [99.7%] received transfusion; 758 total units transfused). At 30 days, MACE occurred in 36 patients (11.0% [95% CI, 7.5%-14.6%]) in the restrictive group and in 45 patients (14.0% [95% CI, 10.0%-17.9%]) in the liberal group (difference, -3.0% [95% CI, -8.4% to 2.4%]). The relative risk of the primary outcome was 0.79 (1-sided 97.5% CI, 0.00-1.19), meeting the prespecified noninferiority criterion. In the restrictive vs liberal group, all-cause death occurred in 5.6% vs 7.7% of patients, recurrent myocardial infarction occurred in 2.1% vs 3.1%, emergency revascularization prompted by ischemia occurred in 1.5% vs 1.9%, and nonfatal ischemic stroke occurred in 0.6% of patients in both groups. CONCLUSIONS AND RELEVANCE Among patients with acute myocardial infarction and anemia, a restrictive compared with a liberal transfusion strategy resulted in a noninferior rate of MACE after 30 days. However, the CI included what may be a clinically important harm. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02648113.
PICO Summary
Population
Patients with myocardial infarction enrolled in the REALITY trial (n= 668).
Intervention
Restrictive transfusion strategy, haemoglobin <8 g/dL (n= 342).
Comparison
Liberal transfusion strategy, haemoglobin <10 g/dL (n = 324).
Outcome
Among the patients in the restrictive transfusion group, 122 (35.7%) received transfusion, compared to 323 (99.7%) patients in the liberal transfusion group. At 30 days, major adverse cardiovascular events occurred in 36 patients (11.0%) in the restrictive group and in 45 patients (14.0%) in the liberal group. In the restrictive vs. liberal group, all-cause death occurred in 5.6% vs. 7.7% of patients, recurrent myocardial infarction occurred in 2.1% vs. 3.1%, emergency revascularization prompted by ischemia occurred in 1.5% vs. 1.9%, and nonfatal ischemic stroke occurred in 0.6% of patients in both groups.
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An economic evaluation of tranexamic acid to prevent postpartum hemorrhage in women with vaginal delivery : the randomized controlled TRAAP trial
Durand-Zaleski I, Deneux-Tharaux C, Seco A, Malki M, Frenkiel J, Sentilhes L
BJOG : an international journal of obstetrics and gynaecology. 2020
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Editor's Choice
Abstract
OBJECTIVE To estimate the cost effectiveness of tranexamic acid (TXA) use to prevent postpartum hemorrhage. DESIGN A trial-based economic evaluation. SETTING 15 French university maternity hospitals. POPULATION women enrolled in the TRAAP randomized controlled trial comparing TXA versus placebo in women with vaginal delivery. TRAAP failed to show a reduction in postpartum hemorrhage of at least 500 ml in the intervention arm but evidenced significant lower rates of secondary outcomes related to blood loss METHODS & MAIN OUTCOME MEASURES We estimated direct medical costs from within-trial hospital resources collected prospectively from the study report form. All resources were costed at their value to the hospital. We estimated incremental cost per incremental hemorrhage averted. RESULTS Among the 4,079 women in the TRAAP trial, data necessary to calculate costs were available for 3,836 (94.0%). The average total costs in the TXA and control groups were €2,278 ±388 and €2,288 ±409 per woman respectively (p= 0.79). In women with postpartum hemorrhage of at least 500 ml (trial primary endpoint), costs were €2,359±354 and €2,409±525 (p=0.14); for provider-assessed clinically significant postpartum hemorrhage and postpartum hemorrhage of at least 1000 ml, costs were respectively €2,316±347 versus €2,381±521 (p=0.22) and €2,321±318versus €2,411±590 (p=0.35) in the tranexamic and placebo groups, respectively. The probabilistic sensitivity analysis showed that the use of TXA had a 65-73% % probability of being cost saving and outcome improving. CONCLUSIONS Our findings support the use of TXA as both bleeding events and cost may be reduced 3 out of 4 times.
PICO Summary
Population
Women enrolled in the Tranexamic Acid for Preventing Postpartum Hemorrhage Following a Vaginal Delivery (TRAAP) trial (n= 3836).
Intervention
Tranexamic acid (TXA), (n= 1918).
Comparison
Placebo (n= 1918).
Outcome
The average total costs in the TXA and control groups were €2,278 ±388 and €2,288 ±409 per woman respectively. In women with postpartum hemorrhage of at least 500 ml (trial primary endpoint), costs were €2,359±354 and €2,409±525); for provider-assessed clinically significant postpartum hemorrhage and postpartum hemorrhage of at least 1000 ml, costs were respectively €2,316±347 vs. €2,381±521 and €2,321±318 vs. €2,411±590 in the tranexamic and placebo groups, respectively. The probabilistic sensitivity analysis showed that the use of TXA had a 65-73% % probability of being cost saving and outcome improving.