CLOT Trial Summary: LMWH vs a coumarin for the prevention of recurrent VTE in patients with cancer

Title: The prevention of recurrent VTE in patients with cancer

Design: Multicenter, open-label, parallel-group, randomized, controlled trial

Objective: To compare LMWH with warfarin in preventing VTE recurrence in patients with cancer and acute symptomatic VTE

N=676

Year of publication: 2003

Inclusion Criteria: patients with any cancer other than basal cell or squamous cell carcinoma and acute symptomatic VTE

Comparison groups: dalteparin (n=338) vs warfarin (n=338)

Primary Outcome:

  • Recurrent VTE (recurrent DVT, nonfatal PE, or fatal PE) HR 0.48; 95% CI 0.30-0.77; 8% vs 5.8% P=0.002

Secondary Outcome:

  • Major Bleeding 6% vs 4% P=0.27
  • Mortality 39% vs 41% P=0.53

Conclusion: In patients with cancer, dalteparin reduced VTE recurrence without increasing bleeding risk or deaths compared to warfarin. Source: Lee AY, et al. et al. NEJM, 2003. 349(2):146-53.