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Symptoms and clinical relevance: A dilemma for clinical trials on prevention of venous thromboembolism

Journal: Thrombosis and Haemostasis
ISSN: 0340-6245
DOI: http://dx.doi.org/10.1160/TH12-08-0627
Issue: 2013: 109/4 (Apr) pp. 569-768
Pages: 585-588

Symptoms and clinical relevance: A dilemma for clinical trials on prevention of venous thromboembolism

H. Bounameaux (1), G. Agnelli (2)

(1) Division of Angiology and Haemostasis and Faculty of Medicine, University Hospitals of Geneva, Geneva, Switzerland; (2) Internal and Cardiovascular Medicine – Stroke Unit, University of Perugia, Perugia, Italy

Keywords

surgery, pulmonary embolism, thrombosis, prophylaxis

Summary

The outcomes of thromboprophylactic trials have been debated for decades. Recently, the 9th edition of the American College of Chest Physicians (ACCP) evidence-based clinical practice guidelines based their strong recommendations only on patient-important outcomes. Practically, symptoms were considered the crucial element. Consequently, studies that primarily aimed at reducing venographic thrombi were considered less pertinent than studies that focused on symptomatic thrombosis. In the present viewpoint, we challenge the argument that “symptomatic” and “clinically relevant” are interchangeable. In particular, the case is made that asymptomatic events may be clinically relevant and that asymptomatic venographically detected thrombosis is a clinically relevant surrogate outcome for fatal pulmonary embolism.

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