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Open Access Original clinical investigation

VTE Risk assessment – a prognostic Model: BATER Cohort Study of young women

Lothar AJ Heinemann1*, Thai DoMinh1, Anita Assmann1, Wolfgang Schramm2, Rolf Schürmann3, Jan Hilpert3 and Michael Spannagl2

Author Affiliations

1 Centre for Epidemiology & Health Research Berlin, Invalidenstr.115, 10115 Berlin, Germany

2 Ludwig-Maximillian-University Munich, Klinikum der Universität, Abteilung Haemostasiologe, Ziemssenstr.1, 80336 Muenchen, Germany

3 Schering AG, SBU Fertility Control/Hormone Therapy, 13342 Berlin, Germany

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Thrombosis Journal 2005, 3:5  doi:10.1186/1477-9560-3-5

Published: 18 April 2005

Abstract

Background

Community-based cohort studies are not available that evaluated the predictive power of both clinical

    and
genetic risk factors for venous thromboembolism (VTE). There is, however, clinical need to forecast the likelihood of future occurrence of VTE, at least qualitatively, to support decisions about intensity of diagnostic or preventive measures.

Materials and methods

A 10-year observation period of the Bavarian Thromboembolic Risk (BATER) study, a cohort study of 4337 women (18–55 years), was used to develop a predictive model of VTE based on clinical and genetic variables at baseline (1993). The objective was to prepare a probabilistic scheme that discriminates women with virtually no VTE risk from those at higher levels of absolute VTE risk in the foreseeable future. A multivariate analysis determined which variables at baseline were the best predictors of a future VTE event, provided a ranking according to the predictive power, and permitted to design a simple graphic scheme to assess the individual VTE risk using five predictor variables.

Results

Thirty-four new confirmed VTEs occurred during the observation period of over 32,000 women-years (WYs). A model was developed mainly based on clinical information (personal history of previous VTE and family history of VTE, age, BMI) and one composite genetic risk markers (combining Factor V Leiden and Prothrombin G20210A Mutation). Four levels of increasing VTE risk were arbitrarily defined to map the prevalence in the study population: No/low risk of VTE (61.3%), moderate risk (21.1%), high risk (6.0%), very high risk of future VTE (0.9%). In 10.6% of the population the risk assessment was not possible due to lacking VTE cases. The average incidence rates for VTE in these four levels were: 4.1, 12.3, 47.2, and 170.5 per 104 WYs for no, moderate, high, and very high risk, respectively.

Conclusion

Our prognostic tool – containing clinical information (and if available also genetic data) – seems to be worthwhile testing in medical practice in order to confirm or refute the positive findings of this study. Our cohort study will be continued to include more VTE cases and to increase predictive value of the model.