Abstract 4199: Influenza Vaccination in Prevention from Coronary Events in Coronary Artery Disease. FLUCAD Study.

Abstract

Background: Influenza vaccination is recommended in patients (p) with cardiovascular disease, however there is few data proving its protective effect on clinical course of coronary artery disease (CAD). We present, to the best of our knowledge, first, randomized, double blind, placebo controlled study in this field. The aim of the study was to evaluate the effect of influenza vaccination on the incidence of coronary events in p with CAD confirmed by coronarography. Methods: Single center, randomized, prospective, double blind, placebo controlled study. The randomization was 1:1 (placebo : active vaccine). Cox proportional hazards model analysis was performed. Study group: Between October 2004 and February 2005, we included and vaccinated 658 CAD p; 477 men, mean age 59.9+/−10.3 years. There were 287 p enrolled before discharge from the hospital after percutaneous coronary intervention (PCI), and 371 p without recent PCI. Results: 325 p received the active vaccine, and 333 p received placebo. There were no significant differences between the study groups. No patient was lost to follow-up. Mean follow-up was 296.8+/−35.7 days. Primary end-point: cardiovascular death occurred in 2 p (0.61%) in the vaccine vs in 2 p (0.60%) in the placebo group (NS). First composite end-point: cardiovascular death, or myocardial infarction, or non-planned coronary revascularization (PCI or coronary bypass surgery) tended to occur less frequently in the vaccine group in comparison to the placebo group: 9 p (2.8%) vs 17 p (5.1%), respectively, (HR 0.54; 95% CI, 0.24 to 1.21; p= 0.13). Second composite end-point: cardiovascular death, or myocardial infarction, or non-planned revascularization or hospitalization for ischemia occurred significantly less frequently in the vaccine group: 16 p (4.9%) vs 30 p (9.0%) in the placebo group, (HR 0.54; 95% CI, 0.29 to 0.991; p=0.047). On multivariate analysis : primary PCI (HR 2.93; 95% CI 1.51 − 5.65, p=0.0014), influenza vaccination (HR 0.38; 95% CI 0.19 − 0.78, p=0.009), and female sex (HR 2.15; 95% CI 1.11 − 4.15, p=0.023), emerged as independent predictors of the occurrence of composite point 2. Conclusion: Influenza vaccination may reduce frequency of coronary events in patients with coronary artery disease.