心肌梗死后射血分数保留的β受体阻滞剂
Beta-Blockers after Myocardial Infarction and Preserved Ejection Fraction.
机构信息
From the Department of Cardiology, Clinical Sciences, Lund University, and Skåne University Hospital, Lund (T.Y., D.E.), the Department of Medical Sciences, Uppsala University (B.L., C.H., J.S.), and Uppsala Clinical Research Center (B.L., C.H., O.Ö.), Uppsala, the Department of Clinical Science and Education, Division of Cardiology, Karolinska Institutet, Södersjukhuset (K.M., R.H.), the Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet (P.H., T.J.), and the Heart and Lung Patients Association (P.J.), Stockholm, the Departments of Cardiology (J.A.) and Health, Medicine, and Caring Sciences (J.A., P.K.), Linköping University, Linköping, the Division of Cardiology, Skaraborgs Sjukhus, Skövde (L.B.), the Division of Cardiology and Emergency Medicine, Centralsjukhuset Karlstad, Karlstad (O.H., T.K.), the Department of Internal Medicine, Ryhov County Hospital, Jönköping (P.K.), and the Department of Cardiology, Sahlgrenska University Hospital, and the Institute of Medicine, Department of Molecular and Clinical Medicine, Sahlgrenska Academy University of Gothenburg, Gothenburg (A.R.-F.) - all in Sweden; Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand (J.B.); the Department of Cardiology, Institute of Clinical Medicine, University of Tartu, Tartu, and the Center of Cardiology, North Estonia Medical Center, Tallinn - both in Estonia (T.M.); and the George Institute for Global Health, University of New South Wales, Sydney (J.S.).
出版信息
N Engl J Med. 2024 Apr 18;390(15):1372-1381. doi: 10.1056/NEJMoa2401479. Epub 2024 Apr 7.
BACKGROUND
Most trials that have shown a benefit of beta-blocker treatment after myocardial infarction included patients with large myocardial infarctions and were conducted in an era before modern biomarker-based diagnosis of myocardial infarction and treatment with percutaneous coronary intervention, antithrombotic agents, high-intensity statins, and renin-angiotensin-aldosterone system antagonists.
METHODS
In a parallel-group, open-label trial performed at 45 centers in Sweden, Estonia, and New Zealand, we randomly assigned patients with an acute myocardial infarction who had undergone coronary angiography and had a left ventricular ejection fraction of at least 50% to receive either long-term treatment with a beta-blocker (metoprolol or bisoprolol) or no beta-blocker treatment. The primary end point was a composite of death from any cause or new myocardial infarction.
RESULTS
From September 2017 through May 2023, a total of 5020 patients were enrolled (95.4% of whom were from Sweden). The median follow-up was 3.5 years (interquartile range, 2.2 to 4.7). A primary end-point event occurred in 199 of 2508 patients (7.9%) in the beta-blocker group and in 208 of 2512 patients (8.3%) in the no-beta-blocker group (hazard ratio, 0.96; 95% confidence interval, 0.79 to 1.16; P = 0.64). Beta-blocker treatment did not appear to lead to a lower cumulative incidence of the secondary end points (death from any cause, 3.9% in the beta-blocker group and 4.1% in the no-beta-blocker group; death from cardiovascular causes, 1.5% and 1.3%, respectively; myocardial infarction, 4.5% and 4.7%; hospitalization for atrial fibrillation, 1.1% and 1.4%; and hospitalization for heart failure, 0.8% and 0.9%). With regard to safety end points, hospitalization for bradycardia, second- or third-degree atrioventricular block, hypotension, syncope, or implantation of a pacemaker occurred in 3.4% of the patients in the beta-blocker group and in 3.2% of those in the no-beta-blocker group; hospitalization for asthma or chronic obstructive pulmonary disease in 0.6% and 0.6%, respectively; and hospitalization for stroke in 1.4% and 1.8%.
CONCLUSIONS
Among patients with acute myocardial infarction who underwent early coronary angiography and had a preserved left ventricular ejection fraction (≥50%), long-term beta-blocker treatment did not lead to a lower risk of the composite primary end point of death from any cause or new myocardial infarction than no beta-blocker use. (Funded by the Swedish Research Council and others; REDUCE-AMI ClinicalTrials.gov number, NCT03278509.).
背景
大多数显示β受体阻滞剂治疗心肌梗死后获益的临床试验都纳入了大面积心肌梗死的患者，并且都是在现代基于生物标志物的心肌梗死诊断和经皮冠状动脉介入治疗、抗血栓药物、高强度他汀类药物和肾素-血管紧张素-醛固酮系统拮抗剂治疗之前进行的。
方法
在瑞典、爱沙尼亚和新西兰的 45 个中心进行的一项平行组、开放标签试验中，我们将接受冠状动脉造影且左心室射血分数至少为 50%的急性心肌梗死患者随机分为接受长期β受体阻滞剂（美托洛尔或比索洛尔）治疗或不接受β受体阻滞剂治疗。主要终点是任何原因死亡或新发心肌梗死的复合终点。
结果
从 2017 年 9 月至 2023 年 5 月，共纳入 5020 例患者（其中 95.4%来自瑞典）。中位随访时间为 3.5 年（四分位距，2.2 至 4.7）。β受体阻滞剂组 2508 例患者中有 199 例（7.9%）发生主要终点事件，无β受体阻滞剂组 2512 例患者中有 208 例（8.3%）（风险比，0.96；95%置信区间，0.79 至 1.16；P=0.64）。β受体阻滞剂治疗似乎并未导致次要终点的累积发生率降低（任何原因死亡，β受体阻滞剂组为 3.9%，无β受体阻滞剂组为 4.1%；心血管原因死亡，分别为 1.5%和 1.3%；心肌梗死，分别为 4.5%和 4.7%；心房颤动住院，分别为 1.1%和 1.4%；心力衰竭住院，分别为 0.8%和 0.9%）。关于安全性终点，β受体阻滞剂组有 3.4%的患者因心动过缓、二度或三度房室传导阻滞、低血压、晕厥或植入起搏器而住院，无β受体阻滞剂组有 3.2%的患者因该原因住院；β受体阻滞剂组有 0.6%的患者因哮喘或慢性阻塞性肺疾病而住院，无β受体阻滞剂组有 0.6%的患者因该原因住院；β受体阻滞剂组有 1.4%的患者因中风而住院，无β受体阻滞剂组有 1.8%的患者因中风而住院。
结论
在早期接受冠状动脉造影且左心室射血分数（≥50%）保留的急性心肌梗死患者中，长期使用β受体阻滞剂治疗并不比不使用β受体阻滞剂治疗的主要复合终点（任何原因死亡或新发心肌梗死）风险更低。（由瑞典研究理事会等资助；RE- DUCE-AMI ClinicalTrials.gov 编号，NCT03278509）。
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