For DVT patients treated with anticoagulants versus no anticoagulants, the risk of dying 

Unanticoagulated DVT patient expected mortality from PE and total mortality from RCT data and from literature data:

• Trial data:
  • The chance of dying in the first three months after a DVT in the control group (i.e., no anticoagulants) in the three randomized controlled trials (22, (27), (28)) totaled: 0/60 = 0%
  • The all cause mortality in the first three months after a DVT in the control group (i.e., no anticoagulants) in the three randomized controlled trials (22, (27), (28)) totaled: 1/60 = 1.7%
• Literature data:
  • No more than 10% of patients presenting with DVT die of any cause within the first month according to a Center For Disease Control report.
  • Two autopsy studies of patients that died of pulmonary embolus showed that between 95% and 96.5% of deaths were in people with underlying terminal illnesses (e.g., cancer, heart failure, etc).(43, 44).
  • Consequently, the chance of an early death in a DVT patient not being due to an underlying terminal illness is < 0.5% (0.10 (10% death rate of DVT patients at most) x 0.05 (5% of deaths in VTE patients at most not due to underlying terminal disease) = 0.005).

Anticoagulated DVT patients’ expected mortality from PE, bleeding, cancer, and all causes from a large non-inferiority RCT and from the medical literature:

• Trial data:
  • Fondaparinux versus enoxaparin non-inferiority RCT by Buller and colleagues:

Anticoagulated PE patients’ expected mortality from PE from literature data (no valid RCT data available):

• Of patients presenting with PE, an estimated 30% will die within a month.
• As above, > 95% of deaths from PE are related to an advanced underlying disease.
• The mortality of non terminally ill patients presenting with PE who die of PE should be in the range of 1.5% (0.30 (30% die within a month) x 0.05 (5% of deaths from PE occur in people without advanced underlying disease) = 0.015)

Conclusion: Trial data for DVT treated without anticoagulants are limited but are confirmed by literature data. For DVT patients with expected survival of > 3 months, the chance of dying in the first 3 months if treated with FDA approved anticoagulant drugs is no better and will likely be worse than with no anticoagulants. In DVT and PE patients without advanced underlying disease (e.g., cancer or heart failure), the estimated chance of dying in the first 3 months with no anticoagulants is < 1% and 1.5%, respectively.