Coronary Artery Disease Clinical Trial
Official title:
Prospective, Randomized, Double-Blind Placebo Controlled Study on Influenza Vaccination in Prevention From Coronary Events in Patients With Coronary Artery Disease Confirmed by Angiography
Background: Influenza vaccination is recommended in patients (pts) with cardiovascular disease, however there is a shortage of clinical studies proving its protective effect on clinical course of coronary artery disease (CAD). The aim of the study was to evaluate the effect of influenza vaccination on the incidence of coronary events in pts with CAD confirmed by coronary angiography.
A possible relation between influenza and higher mortality from cardiovascular problems was
first noticed in early nineteen hundreds, after epidemics in Europe and United States were
discovered (1). In the last decade many studies implicating an important role of
inflammation and infection (Herpes virus, Chlamydia pneumoniae, Helicobacter pylori) in
development and progression of atherosclerosis (2,3), and markers of inflammation like:
hs-CRP, fibrinogen, have become new independent cardiovascular risk factors (4).
Many general physicians now recommend influenza vaccination in patients with coronary artery
disease (CAD) despite shortage of studies proving its protective effect on clinical course
of CAD. In literature we found only a few reports exploring the hypothesis that influenza
vaccination might reduce the incidence of myocardial infarction (MI) and acute coronary
syndromes (ACS).
Naghavi et all. in retrospective, case- control study of 218 patients with chronic coronary
disease reported that influenza vaccination was strongly associated with freedom from new MI
during the same influenza season. (OR 0.33, 95% CI 0.13 to0.82, p=0.017) (5). Gurfinkiel et
all. evaluated in prospective, single- blind Fluvacs study that preventive impact of
vaccination on subsequent ischemic events at 6 months follow-up. Study group consisted of
301 patients after coronary angioplasty (PCI). The first primary outcome- cardiovascular
death occurred in 2% in vaccine group compared with 8% in the control group (p=0.01) and
triple composite end point (death, myocardial infarction and hospitalization from ischemia
occurred in 11% in vaccine group vs. 23% in controls (p=0.0009) (6). In the contrary,
Jackson et all. in largest study of 1378 survivors of first MI, in long (median 2.3 year)
follow-up didn't find the benefit of influenza vaccine on the protection against recurrent
coronary events (7).
The aim of our study is to evaluate the influence of influenza vaccination on the incidence
of cardiac events (cardiovascular death, myocardial infarction, acute coronary syndromes,
coronary revascularization and hospitalizations from ischemia) in patients with
angiographically confirmed coronary disease.
References:
1. Collins SD. Excess mortality from causes other that influenza and pneumonia during
influenza epidemics. Public Health Rep. 1932;47:2159-80.
2. Sorlie PD, Adam E, Melnick SL, et al. Cytomegalovirus/herpesvirus and carotid
atherosclerosis: the ARIC Study. J Med Virol. 1994;42:33-37.
3. Zhou YF, Wanishsawad C, Epstein SE. Chlamydia pneumonia-induced transaction of
cytomegalovirus: potential synergy of infectious agents in the pathogenesis of
atherosclerosis. J Am Coll Cardiol. 1999;33(suppl A):260A.
4. Toss H, Lindahl B, Siegbahn A, Wallentin L. (Frisc study group). Prognostic Influence
of Increased Fibrinogen and C- reactive Protein Levels in Unstable Coronary Artery
Disease. Circulation 1997; 96: 4304- 4210.
5. Naghavi M., Barlas Z., Siadaty S., Nagiub S., Madjid M., Casscells W.: Association of
influenza vaccination and reduced risk of myocardial infarction Circulation 2000;
102:3039-3045.
6. Gurfinkel E.P., Leon de la Fuente R., Mendiz O., Mautner B. For the FLUVACS Study
Group: Influenza vaccine pilot study in acute coronary syndromes and planned
percutaneous coronary interventions. The FLU vaccination acute coronary syndromes
(FLUVACS) Study. Circulation 2002;105:2143-2147.
7. Jackson L.A., Heckbert S.R., Psaty B.M., Malais D., Barlow W.E., Thompson W.W. Vaccine
Safety Datalink Study Group: Influenza vaccination is not associated with a reduction
in the risk of recurrent coronary events. Am. J. Epidemiol. 2002; 156: 634-40.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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