心肌梗死合并贫血的限制性输血或宽松性输血策略。
Restrictive or Liberal Transfusion Strategy in Myocardial Infarction and Anemia.
机构信息
From the Department of Medicine, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ (J.L.C., W.J.K., H.N., S.K.); the Departments of Epidemiology and Biostatistics, School of Public Health, University of Pittsburgh (M.M.B., M.B., S.F.K.), and the Department of Pathology, Division of Transfusion Medicine, University of Pittsburgh School of Medicine (D.J.T.) - both in Pittsburgh; the Bruyere Research Institute, University of Ottawa (P.C.H.), and the Clinical Epidemiology Program, Ottawa Hospital Research Institute (D.A.F.), Ottawa, St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Canadian VIGOUR Centre, University of Alberta (S.G.G.), and the Department of Medicine, Grey Nuns Hospital (M.S.), Edmonton, CHUM Research Centre (B.J.P.), the Departments of Anesthesiology and Medicine, Division of Critical Care, Centre Hospitalier de l'Université de Montréal, Innovation and Evaluation Hub, Centre de Recherche du CHUM (F.M.C., P.C.H.), and the Department of Anesthesiology and Pain Medicine, Université de Montréal (F.M.C.), Montreal, the Department of Medicine, McMaster University, Hamilton, ON (J.D.N.), the Division of Cardiology and Centre for Cardiovascular Innovation, Vancouver General Hospital and University of British Columbia, Vancouver (C.B.F.), and Centre Hospitalier Universitaire (CHU) de Sherbrooke, Université de Sherbrooke, Sherbrooke, QC (B.D.) - all in Canada; the National Heart, Lung, and Blood Institute, Bethesda, MD (S.A.G.); St. Louis University School of Medicine, St. Louis (B.R.C.); FACT (French Alliance for Cardiovascular Trials) (T.S., G.D., P.G.S.), Service de Pharmacologie, Plateforme de Recherche Clinique de l'Est Parisien, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Saint Antoine, Sorbonne Université (T.S.), Université Paris-Cité, INSERM Unité 1148 and AP-HP, Hôpital Bichat (G.D., P.G.S.), Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière AP-HP (J.S.), and AP-HP, Hôpital Européen Georges Pompidou, Department of Cardiology, Université de Paris (E.P.), Paris, Hôpital Pasteur, Service de Cardiologie, CHU Nice, Nice (E.F.), University Hospital of Poitiers, Clinical Investigation Center (INSERM 1204), Cardiology Department, Poitiers (C.B.), and Nimes University Hospital, Montpelier University, ACTION Group, Nimes (B.L.) - all in France; Duke Clinical Research Institute, Duke University, Durham (R.D.L., J.H.A.), and the Department of Medicine, WakeMed Health and Hospitals, Winston-Salem (F.O.W.) - both in North Carolina; Brazilian Clinical Research Institute, Sao Paulo (R.D.L., P.G.M.B.S.); the Department of Medicine, Baystate Medical Center, Springfield (A.M.G.), and the Department of Pathology (L.U.) and Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology (J.B.S.), Beth Israel Deaconess Medical Center, Harvard Medical School, Boston - both in Massachusetts; the University of Nebraska Medical Center, Omaha (A.M.G.); the Department of Medicine, Vanderbilt University Medical Center, Nashville (A.P.D.); Lifespan Cardiovascular Institute and the Department of Medicine, Division of Cardiology, Alpert Medical School of Brown University, Providence, RI (J.D.A.); the Department of Medicine, NYU Langone Health System (S.V.R.), and the Department of Medicine, Montefiore Medical Center (M.A.M.), New York, and the Department of Cardiology, Westchester Medical Center, Valhalla (H.A.C.) - all in New York; the Department of Medicine, University of Louisville, Louiville, KY (S.G.); UChicago AdventHealth Heart and Vascular (M.T.) and the Department of Medicine, University of Chicago Medicine (T.S.P.) - both in Chicago; and Green Lane Coordinating Center, Auckland, New Zealand (C.A., H.D.W.).
出版信息
N Engl J Med. 2023 Dec 28;389(26):2446-2456. doi: 10.1056/NEJMoa2307983. Epub 2023 Nov 11.
BACKGROUND
A strategy of administering a transfusion only when the hemoglobin level falls below 7 or 8 g per deciliter has been widely adopted. However, patients with acute myocardial infarction may benefit from a higher hemoglobin level.
METHODS
In this phase 3, interventional trial, we randomly assigned patients with myocardial infarction and a hemoglobin level of less than 10 g per deciliter to a restrictive transfusion strategy (hemoglobin cutoff for transfusion, 7 or 8 g per deciliter) or a liberal transfusion strategy (hemoglobin cutoff, <10 g per deciliter). The primary outcome was a composite of myocardial infarction or death at 30 days.
RESULTS
A total of 3504 patients were included in the primary analysis. The mean (±SD) number of red-cell units that were transfused was 0.7±1.6 in the restrictive-strategy group and 2.5±2.3 in the liberal-strategy group. The mean hemoglobin level was 1.3 to 1.6 g per deciliter lower in the restrictive-strategy group than in the liberal-strategy group on days 1 to 3 after randomization. A primary-outcome event occurred in 295 of 1749 patients (16.9%) in the restrictive-strategy group and in 255 of 1755 patients (14.5%) in the liberal-strategy group (risk ratio modeled with multiple imputation for incomplete follow-up, 1.15; 95% confidence interval [CI], 0.99 to 1.34; P = 0.07). Death occurred in 9.9% of the patients with the restrictive strategy and in 8.3% of the patients with the liberal strategy (risk ratio, 1.19; 95% CI, 0.96 to 1.47); myocardial infarction occurred in 8.5% and 7.2% of the patients, respectively (risk ratio, 1.19; 95% CI, 0.94 to 1.49).
CONCLUSIONS
In patients with acute myocardial infarction and anemia, a liberal transfusion strategy did not significantly reduce the risk of recurrent myocardial infarction or death at 30 days. However, potential harms of a restrictive transfusion strategy cannot be excluded. (Funded by the National Heart, Lung, and Blood Institute and others; MINT ClinicalTrials.gov number, NCT02981407.).
背景
低于每分升 7 或 8 克的血红蛋白水平时才进行输血的策略已被广泛采用。然而，急性心肌梗死患者可能受益于更高的血红蛋白水平。
方法
在这项 3 期、介入性试验中，我们将血红蛋白水平低于每分升 10 克的心肌梗死患者随机分配至限制输血策略组（输血血红蛋白界值为每分升 7 或 8 克）或自由输血策略组（输血血红蛋白界值，<每分升 10 克）。主要结局为 30 天内的心肌梗死或死亡复合事件。
结果
共有 3504 例患者纳入主要分析。限制输血策略组平均输注红细胞单位数为 0.7±1.6 个，自由输血策略组为 2.5±2.3 个。随机分组后 1 至 3 天，限制输血策略组的平均血红蛋白水平比自由输血策略组低 1.3 至 1.6 克/分升。限制输血策略组 1749 例患者中有 295 例（16.9%）和自由输血策略组 1755 例患者中有 255 例（（不完全随访时用多重插补法建模的风险比，1.15；95%置信区间[CI]，0.99 至 1.34；P=0.07）发生了主要结局事件。限制输血策略组患者死亡 9.9%，自由输血策略组为 8.3%（风险比，1.19；95%CI，0.96 至 1.47）；心肌梗死发生率分别为 8.5%和 7.2%（风险比，1.19；95%CI，0.94 至 1.49）。
结论
在急性心肌梗死合并贫血的患者中，自由输血策略并未显著降低 30 天内再次发生心肌梗死或死亡的风险。然而，不能排除限制输血策略的潜在危害。（由美国国家心肺血液研究所和其他机构资助；MINT ClinicalTrials.gov 编号，NCT02981407。）
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