Influenza vaccination in secondary prevention from coronary ischaemic events in coronary artery disease: FLUCAD study

Influenza vaccination in secondary prevention from coronary ischaemic events in coronary artery disease: FLUCAD study
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DOI:
10.1093/eurheartj/ehm581
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发表时间:
2008-06-01
影响因子:
39.3
通讯作者:
Ruzyllo, Witold
Ruzyllo, Witold
中科院分区:
医学1区
文献类型:
--
作者:
Ciszewski, Andrzej;Bilinska, Zofia T.;Ruzyllo, Witold

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目的评价流感疫苗接种对确诊冠心病患者冠状动脉事件的影响。方法与结果:随机、双盲、安慰剂对照研究。我们纳入了658名接受最佳治疗的冠心病患者,其中477名男性,平均年龄59.9岁+/-10.3岁。325名患者接种了流感疫苗,333名患者服用了安慰剂。中位随访期为298天(四分位数范围为263-317天)。主要终点是心血管死亡。12个月累积事件发生率,疫苗组为0.63%,对照组为0.76%(HR 1.06,95%CI:0.15~7.56,P=0.95)。有两个次级复合终点:(1)与安慰剂组相比,疫苗组MACE(心血管死亡、心肌梗死、冠状动脉血运重建)的发生率更低,发生率分别为3.00%和5.87%(HR 0.54;95%CI:0.24~1.21,P=0.13)。(2)冠脉缺血事件(MACE或心肌缺血住院):疫苗组12个月事件的估计发生率为6.02%,对照组为9.97%(HR0.54;95%CI:0.29~0.99,P=0.047)。结论在经过优化治疗的冠心病患者中,接种流感疫苗可改善冠心病的临床病程,减少冠状动脉缺血事件的发生。有必要进行大规模研究,以评估流感疫苗接种对心血管死亡率的影响。(ClinicalTrials.gov:NCT 00371098)。
Aims To evaluate the effect of influenza vaccination on the coronary events in patients with confirmed coronary artery disease (CAD).Methods and results Randomized, double-blind, placebo controlled study. We included 658 optimally treated CAD patients; 477 men, mean age 59.9 +/- 10.3 years. Three hundred and twenty-five patients received the influenza vaccine, and 333 patients placebo. Median follow-up was 298 (interquartile range 263-317) days. Primary endpoint was the cardiovascular death. Its estimated 12-month cumulative event rate was 0.63% in the vaccine vs. 0.76% in controls (HR 1.06 95% CI: 0.15-7.56, P = 0.95). There were two secondary composite endpoints: (i) the MACE (cardiovascular death, myocardial infarction, coronary revascularization) tended to occur less frequently in the vaccine group vs. placebo with the event rate 3.00 and 5.87%, respectively (HR 0.54; 95% CI: 0.24-1.21, P = 0.13). (ii) Coronary ischaemic event (MACE or hospitalization for myocardial ischaemia) estimated 12-month event rate was significantly lower in the vaccine group 6.02 vs. 9.97% in controls (HR 0.54; 95% CI: 0.29-0.99, P = 0.047).Conclusion In optimally treated CAD patients influenza vaccination improves the clinical course of CAD and reduces the frequency of coronary ischaemic events. Large-scale studies are warranted to evaluate the effect of influenza vaccination on cardiovascular mortality. (ClinicalTrials.gov: NCT 00371098).