Certoparin 3,000 U anti-Xa once daily was as effective as unfractionated heparin 5,000 IU three times daily in preventing thromboembolic events in acutely ill medical patients with cancer (4.50% vs 6.03%; OR 0.73).
RCT (n=3,239)
Double-blind
Randomized
Yes
Does certoparin prevent venous thromboembolic events compared to unfractionated heparin in acutely-ill, non-surgical older patients with cancer?
Certoparin and unfractionated heparin are equally effective and safe for the prevention of venous thromboembolism in acutely ill, non-surgical older patients with cancer.
Odds Ratio: 0.73 (95% CI 0.23–2.39)
Absolute Event Rate: 4.5% vs 6.03%
p-value: p=0.6078
BACKGROUND: Patients with cancer have an increased risk of VTE. We compared VTE rates and bleeding complications in 1) cancer patients receiving LMWH or UFH and 2) patients with or without cancer. METHODS: Acutely-ill, non-surgical patients ≥ 70 years with (n = 274) or without cancer (n = 2,965) received certoparin 3,000 UaXa o.d. or UFH 5,000 IU t.i.d. for 8-20 days. RESULTS: 1) Thromboembolic events in cancer patients (proximal DVT, symptomatic non-fatal PE and VTE-related death) occurred at 4.50% with certoparin and 6.03% with UFH (OR 0.73; 95% CI 0.23-2.39). Major bleeding was comparable and minor bleedings (0.75 vs. 5.67%) were nominally less frequent. 7.5% of certoparin and 12.8% of UFH treated patients experienced serious adverse events. 2) Thromboembolic event rates were comparable in patients with or without cancer (5.29 vs. 4.13%) as were bleeding complications. All cause death was increased in cancer (OR 2.68; 95%CI 1.22-5.86). 10.2% of patients with and 5.81% of those without cancer experienced serious adverse events (OR 1.85; 95% CI 1.21-2.81). CONCLUSIONS: Certoparin 3,000 UaXa o.d. and 5,000 IU UFH t.i.d. were equally effective and safe with respect to bleeding complications in patients with cancer. There were no statistically significant differences in the risk of thromboembolic events in patients with or without cancer receiving adequate anticoagulation. TRIAL REGISTRATION: clinicaltrials.gov, NCT00451412.
Haas et al. (2011) conducted an RCT in Acutely-ill, non-surgical patients with cancer (n=3,239). Certoparin vs. UFH 5,000 IU t.i.d. was evaluated on Combined incidence of proximal DVT, symptomatic non-fatal PE and VTE related death (OR 0.73, 95% CI 0.23-2.39, p=0.6078). Certoparin 3,000 U anti-Xa once daily was as effective as unfractionated heparin 5,000 IU three times daily in preventing thromboembolic events in acutely ill medical patients with cancer (4.50% vs 6.03%; OR 0.73).