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CLINICAL STUDY

A randomized trial of aspirin on the risk of embolic events in patients with infective endocarditis

Kwan-Leung Chan, MD, FRCPC, FACC^*,*, Jean G. Dumesnil, MD, FRCPC, Bibiana Cujec, MD, FRCPC, Anthony J. Sanfilippo, MD, FRCPC, John Jue, MD, FRCPC^||, Michele A. Turek, MD, FRCPC^*, Trevor I. Robinson, MD^¶, David Moher, MSc^* Investigators of the Multicenter Aspirin Study in Infective Endocarditis

^* Department of Medicine, University of Ottawa and University of Ottawa Heart Institute, Ottawa, Canada
Institut de Cardiologie de Québec, Ste-Foy, Quebec, Canada
Department of Medicine, University of Alberta, Edmonton, Alberta, Canada
Department of Medicine, Queen's University, Kingston, Ontario, Canada
^|| Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada
^¶ Department of Medicine, University of Toronto, Toronto, Ontario, Canada

Manuscript received December 4, 2002; revised manuscript received March 4, 2003, accepted March 12, 2003.

^* Reprint requests and correspondence: Dr. Kwan-Leung Chan, University of Ottawa Heart Institute, 40 Ruskin Street, Ottawa, Ontario, Canada K1Y 4W7.
kchan{at}ottawaheart.ca

OBJECTIVES: This study examined the effect of aspirin on the risk of embolic events in infective endocarditis (IE).

BACKGROUND: Embolism is a major complication of IE, and studies in animal models have shown that platelet inhibition with aspirin can lead to more rapid vegetation resolution and a lower rate of embolic events.

METHODS: We conducted a randomized, double-blinded, placebo-controlled trial of aspirin treatment (325 mg/day) for four weeks in patients with IE to test the hypothesis that the addition of aspirin would reduce the incidence of clinical systemic embolic events. Patients with perivalvular abscess were excluded. Serial cerebral computed tomograms and transesophageal echocardiograms were obtained in a subset of patients.

RESULTS: During the four-year study period, 115 patients were enrolled: 60 assigned to aspirin and 55 assigned to placebo. Embolic events occurred in 17 patients (28.3%) on aspirin and 11 patients (20.0%) on placebo, with an odds ratio (OR) of 1.62 (95% confidence interval [CI] 0.68 to 3.86, p = 0.29). There was a trend toward a higher incidence of bleeding in the patients taking aspirin versus placebo (OR 1.92, 95% CI 0.76 to 4.86, p = 0.075). Development of new intracranial lesions was similar in both groups. Aspirin had no effect on vegetation resolution and valvular dysfunction.

CONCLUSIONS: In endocarditis patients already receiving antibiotic treatment, the addition of aspirin does not appear to reduce the risk of embolic events and is likely associated with an increased risk of bleeding. Aspirin is not indicated in the early management of patients with IE.

Abbreviations and Acronyms   CI   confidence interval   IE   infective endocarditis   OR   odds ratio

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