Journal Articles

Venous Thromboembolism and Cardiovascular Risk: Results from the NAVIGATOR Trial

November 20, 2014

Venous Thromboembolism and Cardiovascular Risk: Results from the NAVIGATOR Trial   The American Journal of Medicine, 20 November 2014,  Marcelo Katz, MDa, b, Robert M. Califf, MDc, Jie-Lena Sun, MSd, John J.V. McMurray, MDe, Laine Thomas, PhDd, Renato D. Lopes, MD, PhD, MHSd,

  • Brazilian Clinical Research Institute, Sao Paulo, Brazil
  • b Hospital Israelita Albert Einstein, Sao Paulo, Brazil
  • c Duke Translational Medicine Institute, Duke University Medical Center, Durham, NC
  • d Duke Clinical Research Institute, Duke University Medical Center, Durham, NC
  • e BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland, UK

Venous Thromboembolism and Cardiovascular Risk: Results from the NAVIGATOR Trial

Abstract

Background

Contemporary studies suggest an association between venous thromboembolism and a higher incidence of major cardiovascular events, mostly attributed to arterial atherothrombosis. Using data from the Nateglinide and Valsartan in Impaired Glucose Tolerance Outcomes Research (NAVIGATOR) trial, we assessed the association of venous thromboembolism with major cardiovascular events.

Methods

In NAVIGATOR, patients with impaired glucose tolerance were randomly allocated to receive valsartan or placebo and nateglinide or placebo in addition to lifestyle modification. Baseline characteristics and prior history of venous thromboembolism were assessed. After adjusting for important baseline covariates, Cox proportional hazards regression models were used to assess the association between venous thromboembolism and major cardiovascular outcomes.

Results

Of the 9306 patients enrolled, 129 (1.4%) had a history of venous thromboembolism. Patients with venous thromboembolism were older, more frequently white and female, and had a higher body mass index. Patients with venous thromboembolism had higher 5-year event rates for the composite of death, myocardial infarction, and stroke as compared with patients without venous thromboembolism (10.7% vs. 5.9%; P<0.001; adjusted hazard ratio [HR] 2.12, 95% confidence interval [CI] 1.36–3.31; P=0.001).

Conclusion

In patients with impaired glucose tolerance at high risk for cardiovascular events, the prevalence of venous thromboembolism was rare but associated with worse long-term cardiovascular outcomes, including arterial events. Venous thromboembolism is a marker of risk, and attention should be paid to this high-risk group of patients.

Clinical trial registration

ClinicalTrials.gov: NCT00097786.

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