Asymptomatic Deep Vein Thrombosis is Associated with an Increased Risk of Death: Insights from the APEX Trial.

Journal Article (Clinical Trial;Journal Article)

AIM:  Asymptomatic deep vein thrombosis (DVT) diagnosed with compression ultrasound (CUS) is a common endpoint in trials assessing the efficacy of anticoagulants to prevent venous thromboembolism (VTE), but the relationship of asymptomatic thrombus to mortality remains uncertain. METHODS:  In the APEX trial ( NCT01583218), 7,513 acutely ill hospitalized medical patients were randomly assigned to extended-duration betrixaban (35-42 days) or enoxaparin (10 ± 4 days). Asymptomatic DVT was assessed once with CUS between day 32 and 47, and mortality was assessed through 77 days. RESULTS:  A total of 309 asymptomatic DVTs were detected through CUS. Of these, 133 (4.27%) subjects were in the betrixaban group, and 176 (5.55%) subjects were in the enoxaparin group (relative risk = 0.77, 95% confidence interval [CI] = 0.62-0.97, p = 0.025, number needed to treat = 79). With respect to all-cause mortality due to cardiovascular diseases, non-cardiovascular diseases and unknown causes, the number of the deaths was 5 (1.67%), 4 (1.34%) and 1 (0.33%) in the asymptomatic DVT group and 25 (0.42%), 33 (0.56%) and 11 (0.19%) in the no DVT group, respectively. Subjects with an asymptomatic DVT had an almost threefold increase in the risk of all-cause mortality compared with subjects without DVT (hazard ratio = 2.87, 95% CI = 1.48-5.57, p = 0.001). A positive linear trend was observed between greater thrombus burden and mortality during the follow-up (p = 0.019). CONCLUSION:  Asymptomatic DVT was associated with approximately threefold increased risk of short-term all-cause mortality in patients hospitalized with an acute medical illness within the prior 77 days. A positive linear trend was observed between greater thrombus burden and mortality during the follow-up.

Full Text

Duke Authors

Cited Authors

  • Kalayci, A; Gibson, CM; Chi, G; Yee, MK; Korjian, S; Datta, S; Nafee, T; Gurin, M; Haroian, N; Qamar, I; Hull, RD; Hernandez, AF; Cohen, AT; Harrington, RA; Goldhaber, SZ

Published Date

  • December 2018

Published In

  • Thromb Haemost

Volume / Issue

  • 118 / 12

Start / End Page

  • 2046 - 2052

PubMed ID

  • 30419597

Pubmed Central ID

  • 30419597

Electronic International Standard Serial Number (EISSN)

  • 2567-689X

Digital Object Identifier (DOI)

  • 10.1055/s-0038-1675606


  • eng

Conference Location

  • Germany