Borja Ibanez, Roberto Latini, Xavier Rossello, Alberto Dominguez-Rodriguez, Felipe Fernández-Vazquez, Valentina Pelizzoni, Pedro L Sánchez, Manuel Anguita, José A Barrabés, Sergio Raposeiras-Roubín, Stuart Pocock, Noemí Escalera, Lidia Staszewsky, Carlos Nicolás Pérez-García, Pablo Díez-Villanueva, Jose-Angel Pérez-Rivera, Oscar Prada-Delgado, Ruth Owen, Gonzalo Pizarro, Onofre Caldes, Sandra Gómez-Talavera, José Tuñón, Matteo Bianco, Jesus Zarauza, Alfredo Vetrano, Ana Campos, Susana Martínez-Huertas, Héctor Bueno, Miguel Puentes, Giulietta Grigis, Juan L Bonilla-Palomas, Elvira Marco, José R González-Juanatey, Roi Bangueses, Carlos González-Juanatey, Ana García-Álvarez, Juan Ruiz-García, Anna Carrasquer, Juan C García-Rubira, Domingo Pascual-Figal, Carlos Tomás-Querol, J Alberto San Román, Pasquale Baratta, Jaume Agüero, Roberto Martín-Reyes, Furio Colivicchi, Rosario Ortas-Nadal, Pablo Bazal, Alberto Cordero, Antonio Fernández-Ortiz, Pierangelo Basso, Eva González, Fabrizio Poletti, Giulia Bugani, Marzia Debiasio, Deborah Cosmi, Alessandro Navazio, Javier Bermejo, Giovanni Tortorella, Marco Marini, Javier Botas, José M de la Torre-Hernández, Filippo Ottani, Valentín Fuster
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引用次数: 0
Abstract
Background: Current guideline recommendations for the use of beta-blockers after myocardial infarction without reduced ejection fraction are based on trials conducted before routine reperfusion, invasive care, complete revascularization, and contemporary pharmacologic therapies became standard practice.
Methods: We conducted an open-label, randomized trial in Spain and Italy to evaluate the effect of beta-blocker therapy, as compared with no beta-blocker therapy, in patients with acute myocardial infarction (with or without ST-segment elevation) and a left ventricular ejection fraction above 40%. The primary outcome was a composite of death from any cause, reinfarction, or hospitalization for heart failure.
Results: In total, 4243 patients were randomly assigned to receive beta-blocker therapy and 4262 to receive no beta-blocker therapy; after exclusions, 8438 patients were included in the main analysis. During a median follow-up of 3.7 years, a primary-outcome event occurred in 316 patients (22.5 events per 1000 patient-years) in the beta-blocker group and in 307 patients (21.7 events per 1000 patient-years) in the no-beta-blocker group (hazard ratio, 1.04; 95% confidence interval [CI], 0.89 to 1.22; P = 0.63). Death from any cause occurred in 161 patients and 153 patients, respectively (11.2 vs. 10.5 events per 1000 patient-years; hazard ratio, 1.06; 95% CI, 0.85 to 1.33); reinfarction in 143 patients and 143 patients (10.2 vs. 10.1 events per 1000 patient-years; hazard ratio, 1.01; 95% CI, 0.80 to 1.27); and hospitalization for heart failure in 39 patients and 44 patients (2.7 vs. 3.0 events per 1000 patient-years; hazard ratio, 0.89; 95% CI, 0.58 to 1.38). No apparent between-group differences in safety outcomes were noted.
Conclusions: Among patients discharged after invasive care for a myocardial infarction with a left ventricular ejection fraction above 40%, beta-blocker therapy appeared to have no effect on the incidence of death from any cause, reinfarction, or hospitalization for heart failure. (Funded by Centro Nacional de Investigaciones Cardiovasculares Carlos III and others; ClinicalTrials.gov number, NCT03596385; EudraCT number, 2017-002485-40.).
背景：目前关于无射血分数降低的心肌梗死后使用β受体阻滞剂的指南建议是基于常规再灌注、侵入性护理、完全血运重建和当代药物治疗成为标准实践之前进行的试验。方法：我们在西班牙和意大利进行了一项开放标签的随机试验，以评估β受体阻滞剂治疗与无β受体阻滞剂治疗在急性心肌梗死（伴有或不伴有st段抬高）和左室射血分数高于40%的患者中的效果。主要结局是任何原因死亡、再梗死或因心力衰竭住院的综合结果。结果：共有4243例患者被随机分配接受受体阻滞剂治疗，4262例患者未接受受体阻滞剂治疗；排除后，8438例患者纳入主分析。在中位随访3.7年期间，β受体阻滞剂组中有316例患者（每1000患者年22.5例事件）发生主要结局事件，无β受体阻滞剂组中有307例患者（每1000患者年21.7例事件）发生主要结局事件（风险比为1.04；95%可信区间[CI]， 0.89至1.22;P = 0.63）。任何原因导致的死亡分别发生在161名患者和153名患者（11.2 vs 10.5事件/ 1000患者年；风险比为1.06；95% CI为0.85 ~ 1.33）；143例患者和143例患者再梗死（10.2 vs 10.1事件/ 1000患者-年；风险比1.01;95% CI 0.80 ~ 1.27）；39例患者和44例患者因心力衰竭住院（2.7 vs 3.0事件/ 1000患者年；风险比0.89;95% CI 0.58 ~ 1.38）。安全结果未见组间明显差异。结论：在左心室射血分数高于40%的心肌梗死有创治疗后出院的患者中，β受体阻滞剂治疗似乎对任何原因死亡、再梗死或心力衰竭住院的发生率没有影响。（由Centro national de Investigaciones cardiovascular Carlos III等资助；ClinicalTrials.gov编号：NCT03596385； eudraft编号：2017-002485-40）。
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