Influenza Vaccination After Myocardial Infarction: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial

被引:170
作者
Frobert, Ole [1 ]
Gotberg, Matthias [2 ]
Erlinge, David [2 ]
Akhtar, Zubair [3 ]
Christiansen, Evald H. [4 ]
MacIntyre, Chandini R. [5 ]
Oldroyd, Keith G. [6 ,7 ]
Motovska, Zuzana [8 ,9 ]
Erglis, Andrejs [10 ]
Moer, Rasmus [11 ]
Hlinomaz, Ota [12 ,13 ]
Jakobsen, Lars [4 ]
Engstrom, Thomas [14 ]
Jensen, Lisette O. [15 ]
Fallesen, Christian O. [15 ]
Jensen, Svend E. [16 ,17 ]
Angeras, Oskar [18 ,19 ]
Calais, Fredrik [1 ]
Karegren, Amra [20 ]
Lauermann, Jorg [21 ,22 ]
Mokhtari, Arash [2 ]
Nilsson, Johan [23 ]
Persson, Jonas [24 ]
Stalby, Per [25 ]
Islam, Abu K. M. M. [26 ]
Rahman, Afzalur [26 ]
Malik, Fazila [27 ]
Choudhury, Sohel [27 ]
Collier, Timothy [28 ]
Pocock, Stuart J. [28 ]
Pernow, John [29 ,30 ]
机构
[1] Orebro Univ, Fac Hlth, Dept Cardiol, S-70185 Orebro, Sweden
[2] Lund Univ, Skane Univ Hosp, Dept Cardiol, Clin Sci, Lund, Sweden
[3] Int Ctr Diarrhoea Dis Res, Dhaka, Bangladesh
[4] Aarhus Univ Hosp, Dept Cardiol, Aarhus, Denmark
[5] Univ New South Wales, Kirby Inst, UNSW Med, Sydney, NSW, Australia
[6] Univ Glasgow, British Heart Fdn Glasgow Cardiovasc Res, Inst Cardiovasc & Med Sci, Glasgow, Lanark, Scotland
[7] Golden Jubilee Natl Hosp, West Scotland Heart & Lung Ctr, Glasgow, Lanark, Scotland
[8] Charles Univ Prague, Cardioctr, Fac Med 3, Prague, Czech Republic
[9] Univ Hosp Kralovske Vinohrady, Prague, Czech Republic
[10] Univ Latvia, Pauls Stradins Clin Univ Hosp, Riga, Latvia
[11] LHL Sykehuset Gardermoen, Oslo, Norway
[12] St Anne Univ Hosp, Inter Natl Clin Res Ctr, Brno, Czech Republic
[13] Masaryk Univ, Brno, Czech Republic
[14] Univ Copenhagen, Rigshosp, Copenhagen, Denmark
[15] Odense Univ Hosp, Dept Cardiol, Odense, Denmark
[16] Aalborg Univ, Dept Cardiol, Aalborg Univ Hosp, Aalborg, Denmark
[17] Aalborg Univ, Dept Clin Med, Aalborg, Denmark
[18] Gothenburg Univ, Sahlgrenska Univ Hosp, Gothenburg, Sweden
[19] Gothenburg Univ, Dept Mol & Clin Med, Inst Med, Gothenburg, Sweden
[20] Vastmanlands Sjukhus Vasteras, Vasteras, Sweden
[21] Dept Cardiol, Jonkoping, Sweden
[22] Linkoping Univ, Dept Hlth Med & Caring, Linkoping, Sweden
[23] Umea Univ, Dept Publ Hlth & Clin Med, Heart Ctr, Cardiol, Umea, Sweden
[24] Karolinska Inst, Danderyd Univ Hosp, Dept Clin Sci, Div Cardiovasc Med, Stockholm, Sweden
[25] Karlstad Cent Hosp, Dept Cardiol, Karlstad, Sweden
[26] Natl Inst Cardiovasc Dis, Dhaka, Bangladesh
[27] Natl Heart Fdn Hosp & Res Inst, Dhaka, Bangladesh
[28] London Sch Hyg & Trop Med, Dept Med Stat, London, England
[29] Karolinska Inst, Dept Med Solna, Cardiol Unit, Stockholm, Sweden
[30] Karolinska Univ Hosp, Stockholm, Sweden
关键词
influenza vaccines; myocardial infarction; randomized controlled trial; CORONARY-ARTERY-DISEASE; SECONDARY PREVENTION; RISK; INFECTION; ASSOCIATION; OUTCOMES; EVENTS;
D O I
10.1161/CIRCULATIONAHA.121.057042
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background: Observational and small, randomized studies suggest that influenza vaccine may reduce future cardiovascular events in patients with cardiovascular disease. Methods: We conducted an investigator-initiated, randomized, double-blind trial to compare inactivated influenza vaccine with saline placebo administered shortly after myocardial infarction (MI; 99.7% of patients) or high-risk stable coronary heart disease (0.3%). The primary end point was the composite of all-cause death, MI, or stent thrombosis at 12 months. A hierarchical testing strategy was used for the key secondary end points: all-cause death, cardiovascular death, MI, and stent thrombosis. Results: Because of the COVID-19 pandemic, the data safety and monitoring board recommended to halt the trial before attaining the prespecified sample size. Between October 1, 2016, and March 1, 2020, 2571 participants were randomized at 30 centers across 8 countries. Participants assigned to influenza vaccine totaled 1290 and individuals assigned to placebo equaled 1281; of these, 2532 received the study treatment (1272 influenza vaccine and 1260 placebo) and were included in the modified intention to treat analysis. Over the 12-month follow-up, the primary outcome occurred in 67 participants (5.3%) assigned influenza vaccine and 91 participants (7.2%) assigned placebo (hazard ratio, 0.72 [95% CI, 0.52-0.99]; P=0.040). Rates of all-cause death were 2.9% and 4.9% (hazard ratio, 0.59 [95% CI, 0.39-0.89]; P=0.010), rates of cardiovascular death were 2.7% and 4.5%, (hazard ratio, 0.59 [95% CI, 0.39-0.90]; P=0.014), and rates of MI were 2.0% and 2.4% (hazard ratio, 0.86 [95% CI, 0.50-1.46]; P=0.57) in the influenza vaccine and placebo groups, respectively. Conclusions: Influenza vaccination early after an MI or in high-risk coronary heart disease resulted in a lower risk of a composite of all-cause death, MI, or stent thrombosis, and a lower risk of all-cause death and cardiovascular death, as well, at 12 months compared with placebo. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02831608.
引用
收藏
页码:1476 / 1484
页数:9
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