Influenza Vaccination in Secondary Prevention From Coronary Ischemic Events in Coronary Artery Disease - FLUCAD

Mar 01, 2008
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Trial Sponsor:
Study funded by a grant of Polish Ministry of Education and Science; vaccine and placebo provided by Solvay Pharmaceuticals B.V.
Date Published:
01/01/2008
Date Updated:
03/01/2008
Original Posted Date:
03/01/2008
References

Description:

The goal of this trial was to evaluate the effect of influenza vaccination on the incidence of coronary ischemic events in optimally treated patients with coronary artery disease (CAD).

Hypothesis:

Influenza vaccination would reduce the incidence of future coronary ischemic events in patients with established and optimally treated CAD.

Study Design

Study Design:

Patients Screened: 877
Patients Enrolled: 658
NYHA Class: I/II
Mean Follow Up: 12 months
Mean Patient Age: 58.4 years
Female: 28
Mean Ejection Fraction: 52.5%

Patient Populations:

• Age 30-80 years
• CAD confirmed by angiography with at least 50% stenosis of at least one large epicardial coronary artery

Exclusions:

• Congestive cardiac failure with New York Heart Association class III/IV symptoms
• Planned cardiovascular surgery within 6 months
• Evolving renal failure
• Neoplastic disease
• Pyscho-organic disorder
• Contraindication to vaccination
• Any factor impeding follow-up

Primary Endpoints:

Cardiovascular death at 12 months

Secondary Endpoints:

• MACE: composite of cardiovascular death, acute myocardial infarction, or coronary revascularization at 12 months
• Coronary ischemic event: MACE or hospitalization for myocardial ischemia at 12 months

Drug/Procedures Used:

Patients with established CAD were randomized to receiving intramuscular single inactivated subunit influenza vaccine containing 0.5 ml dose (15 µg) hemagglutinin of each of the following strains: A/NewCaledonia/20/99 (H1N1), A/Christchurch/28/03 (H3N2), B/Jiangsu/10/03, or placebo containing all vaccine compounds except viral antigens.

Concomitant Medications:

Patients were optimally treated for CAD with aspirin (97.6%), thienopyridines (48.5%), statins (98.5%), beta-blockers (93.9%), and angiotensin-converting enzyme inhibitors (92.6%).

Principal Findings:

A total of 658 patients were included and vaccinated: 325 with the influenza vaccine, and 333 with placebo. Baseline characteristics were fairly comparable between the two groups. Of the patients recruited, about 56.3% had medically-managed stable angina, 19.9% underwent elective percutaneous coronary intervention (PCI) for stable angina, and the rest underwent PCI for acute coronary syndromes (ACS). Adverse events were not significantly different between the two groups.

The rate for the primary endpoint of cardiovascular death was 0.63% in the vaccinated group and 0.76% in the placebo group (hazard ratio [HR] 1.06, 95% confidence interval [CI] 0.15-7.56; p = 0.95). There were two secondary composite endpoints. Major adverse cardiac events (MACE) were nonsignificantly reduced in the vaccinated group (HR 0.54, 95% CI 0.24-1.21; p = 0.13). The incidence of coronary ischemic events (MACE or hospitalization for coronary ischemia) was significantly reduced in the vaccinated arm (6.0%) vs. the placebo arm (10.0%) (HR 0.54, 95% CI 0.29-0.99; p = 0.047). On multivariate analysis, female gender and recent ACS were associated with a higher incidence of coronary ischemic events, whereas influenza vaccination was associated with a lower incidence of coronary ischemic events.

Interpretation:

AHA/ACC Guidelines for Secondary Prevention for Patients With Coronary and Other Atherosclerotic Vascular Disease: 2006 Update (J Am Coll Cardiol 2006;47:2130-9) recommend influenza vaccination in all patients with established CAD (Class I, Level of Evidence: B), whereas the current European Society of Cardiology guidelines make no specific recommendations regarding the same. The results of this small placebo-controlled trial indicate that influenza vaccination is not associated with a lower incidence of cardiovascular death or myocardial infarction at 12 months in patients with established and optimally treated CAD, but does reduce the incidence of other coronary ischemic events.

References:

Ciszewski A, Bilinska ZT, Brydak LB, et al. Influenza vaccination in secondary prevention from coronary ischaemic events in coronary artery disease: FLUCAD study. Eur Heart J 2008;Jan 10:[Epub ahead of print].

Keywords: Acute Coronary Syndrome, Myocardial Infarction, Coronary Artery Disease, Atherosclerosis, Multivariate Analysis, Influenza Vaccines, Angina, Stable, Hemagglutinins, Constriction, Pathologic, Percutaneous Coronary Intervention, Influenza A Virus, H1N1 Subtype, Confidence Intervals, Vaccination


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