Individualized transfusion decisions to minimize adverse cardiovascular outcomes in patients with acute myocardial infarction and anemia

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS American heart journal Pub Date : 2025-01-17 DOI:10.1016/j.ahj.2025.01.009

Gerard T. Portela PhD , Gregory Ducrocq MD , Marnie Bertolet PhD , John H. Alexander MD, MHS , Shaun G. Goodman MD , Simone Glynn MD, MPH, MSc , Jordan B. Strom MD, MSc , Sonja A. Swanson ScD , Gilles Lemesle MD , Sunil V. Rao MD , Meechai Tessalee MD , Tamar S. Polonsky MD, MSCI , Michael Goldfarb MD, MSc , Jay H. Traverse MD, ME , Lynne Uhl MD , Brandon M. Herbert MPH, PhD , Johanne Silvain MD, PhD , Jeffrey L. Carson MD , Maria M. Brooks PhD , MINT Trial Investigators

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Abstract

Background

Risk-benefit tradeoffs between restrictive versus liberal red blood cell transfusion strategies may vary across individuals. This exploratory analysis aimed to derive and evaluate individualized treatment effects of defined transfusion strategies in patients with acute MI and anemia with the goal of minimizing adverse cardiovascular outcomes.

Methods

This study analyzed 3,447 (98.4%) patients randomized in the MINT (Myocardial Ischemia and Transfusion) trial between April 2017 to April 2023. Outcomes for this analysis included 30-day death or recurrent MI, death, and major adverse cardiovascular events (MACE, a composite of death, MI, stroke, and ischemia-driven unscheduled revascularization). Machine learning methods were used to identify baseline patient characteristics that informed the individualized treatment effect of a restrictive versus liberal transfusion strategy for each patient. The expected population risk of an outcome under a scenario in which patients received their optimal treatment, as indicated by the individualized treatment effect, was contrasted with expected risks for universally applying a restrictive strategy or a liberal strategy to all patients.

Results

Baseline characteristics did not inform individualized treatment effects on 30-day death and death or MI, suggesting minimal heterogeneity in treatment effect on these outcomes. An algorithm for estimating the individualized treatment effect on 30-day MACE included 12 baseline factors. If all patients received the optimal treatment as indicated by their estimated individualized treatment effect, the predicted risk of 30-day MACE in the sample population was 15.2% (95% CI 14.2%-16.2%). This corresponded to 4.0 (difference: −4.0%, 95% CI −5.8, −2.1) and 2.3 (difference: −2.3%, 95% CI −3.7, −0.9) percentage point risk reductions compared to applying a restrictive or liberal strategy to everyone respectively.

Conclusions

The MINT trial average treatment effect, favoring a liberal strategy, may be optimal to minimize risk of 30-day death and death or MI for acute MI patients with anemia represented in the MINT sample as no individualized treatment effects were estimated on these outcomes. However, individualized transfusion strategy decisions have potential to reduce risk of 30-day MACE. External validation of the MACE algorithm is required before clinical use.

Trial Registration

ClinicalTrials.gov, NCT02981407, https://clinicaltrials.gov/study/NCT02981407.

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对急性心肌梗死和贫血患者进行个体化输血以减少不良心血管结局。

背景：限制与自由红细胞输血策略之间的风险-收益权衡可能因个体而异。本探索性分析旨在得出并评估明确的输血策略对急性心肌梗死和贫血患者的个体化治疗效果，以最大限度地减少不良心血管结局。方法：本研究分析了2017年4月至2023年4月在MINT（心肌缺血和输血）试验中随机分配的3447例（98.4%）患者。该分析的结果包括30天死亡或复发性心肌梗死、死亡和主要不良心血管事件（MACE，死亡、心肌梗死、中风和缺血驱动的非计划性血运重建的复合）。使用机器学习方法来确定基线患者特征，这些特征为每位患者提供了限制性和自由输血策略的个性化治疗效果。个体治疗效果表明，在患者接受最佳治疗的情况下，结果的预期人群风险与对所有患者普遍应用限制性策略或自由策略的预期风险进行对比。结果：基线特征并没有告诉个体化治疗对30天死亡和死亡或心肌梗死的影响，表明治疗对这些结果的影响具有最小的异质性。估计30天MACE个体化治疗效果的算法包括12个基线因素。如果所有患者都接受了根据其估计的个体化治疗效果所指示的最佳治疗，则样本人群中30天MACE的预测风险为15.2% （95% CI 14.2%至16.2%）。与对每个人分别应用限制性或自由策略相比，这对应于4.0（差异：-4.0%,95% CI -5.8, -2.1）和2.3（差异：-2.3%,95% CI -3.7, -0.9）个百分点的风险降低。结论：MINT试验的平均治疗效果倾向于自由策略，对于MINT样本中伴有贫血的急性心肌梗死患者的30天死亡和死亡或心肌梗死的风险可能是最佳的，因为没有估计个体化治疗效果对这些结果的影响。然而，个性化的输血策略决策有可能降低30天MACE的风险。MACE算法在临床使用前需要进行外部验证。试验注册：ClinicalTrials.gov, NCT02981407, https://clinicaltrials.gov/study/NCT02981407。

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来源期刊

American heart journal 医学-心血管系统

CiteScore

8.20

自引率

2.10%

发文量

214

审稿时长

38 days

期刊介绍： The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.