Abstract
Standard treatment with heparin followed by vitamin K antagonists is frequently complicated by bleeding and recurrent venous thromboembolism (VTE) in cancer patients with VTE. To compare the efficacy, safety and overall survival of long-term idraparinux treatment to standard therapy in cancer patients we conducted a post-hoc analysis in the subgroup of non-active and active cancer patients included in the Van Gogh DVT clinical trial. The cancer patients with deep venous thrombosis (DVT) and without pulmonary embolism (PE) were randomised to standard treatment or a once-weekly subcutaneous injection of idraparinux (2.5 mg), a synthetic pentasaccharide. 421 cancer patients were included. A total of 220 patients received idraparinux and 201 were allocated to standard therapy for three months (8%) or six months (92%). A recurrent VTE was observed during the first six months in 2.5% (n=5) of the idraparinux recipients compared to 6.4% (n=12) in the standard therapy group (hazard ratio 0.39, 95% confidence interval [CI]; 0.14-1.11). The rate of bleeding was comparable (odds ratio 0.89, 95% CI; 0.50-1.59). The outcomes were similar at three months after randomisation in all patients. Of the idraparinux recipients, 22.7% (n=50) died during the study period compared to 48 patients (23.9%) in the standard treatment group (hazard ratio 0.99, 95% CI; 0.66-1.48). In conclusion, no significant safety or survival differences were observed between cancer patients with DVT treated with idraparinux for six months compared to standard therapy. Fewer recurrent VTEs were observed in the idraparinux group; however, this was not statistically significant and also because of study limitations this should be interpreted with caution.
| Original language | English |
|---|---|
| Pages (from-to) | 86-91 |
| Number of pages | 6 |
| Journal | Thrombosis and Haemostasis |
| Volume | 104 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Jul 2010 |
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Keywords
- Anticoagulation
- Cancer
- Deep venous thrombosis
- Idraparinux
ASJC Scopus subject areas
- Hematology
Cite this
Idraparinux versus standard therapy in the treatment of deep venous thrombosis in cancer patients : A subgroup analysis of the Van Gogh DVT trial. / Van Doormaal, Frederiek F.; Cohen, Alexander T.; Davidson, Bruce L.; Decousus, Herve; Gallus, Alexander S.; Gent, Michael; Piovella, Franco; Prins, Martin H.; Raskob, Gary E.; Büller, Harry R.
In: Thrombosis and Haemostasis, Vol. 104, No. 1, 07.2010, p. 86-91.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Idraparinux versus standard therapy in the treatment of deep venous thrombosis in cancer patients
T2 - A subgroup analysis of the Van Gogh DVT trial
AU - Van Doormaal, Frederiek F.
AU - Cohen, Alexander T.
AU - Davidson, Bruce L.
AU - Decousus, Herve
AU - Gallus, Alexander S.
AU - Gent, Michael
AU - Piovella, Franco
AU - Prins, Martin H.
AU - Raskob, Gary E.
AU - Büller, Harry R.
PY - 2010/7
Y1 - 2010/7
N2 - Standard treatment with heparin followed by vitamin K antagonists is frequently complicated by bleeding and recurrent venous thromboembolism (VTE) in cancer patients with VTE. To compare the efficacy, safety and overall survival of long-term idraparinux treatment to standard therapy in cancer patients we conducted a post-hoc analysis in the subgroup of non-active and active cancer patients included in the Van Gogh DVT clinical trial. The cancer patients with deep venous thrombosis (DVT) and without pulmonary embolism (PE) were randomised to standard treatment or a once-weekly subcutaneous injection of idraparinux (2.5 mg), a synthetic pentasaccharide. 421 cancer patients were included. A total of 220 patients received idraparinux and 201 were allocated to standard therapy for three months (8%) or six months (92%). A recurrent VTE was observed during the first six months in 2.5% (n=5) of the idraparinux recipients compared to 6.4% (n=12) in the standard therapy group (hazard ratio 0.39, 95% confidence interval [CI]; 0.14-1.11). The rate of bleeding was comparable (odds ratio 0.89, 95% CI; 0.50-1.59). The outcomes were similar at three months after randomisation in all patients. Of the idraparinux recipients, 22.7% (n=50) died during the study period compared to 48 patients (23.9%) in the standard treatment group (hazard ratio 0.99, 95% CI; 0.66-1.48). In conclusion, no significant safety or survival differences were observed between cancer patients with DVT treated with idraparinux for six months compared to standard therapy. Fewer recurrent VTEs were observed in the idraparinux group; however, this was not statistically significant and also because of study limitations this should be interpreted with caution.
AB - Standard treatment with heparin followed by vitamin K antagonists is frequently complicated by bleeding and recurrent venous thromboembolism (VTE) in cancer patients with VTE. To compare the efficacy, safety and overall survival of long-term idraparinux treatment to standard therapy in cancer patients we conducted a post-hoc analysis in the subgroup of non-active and active cancer patients included in the Van Gogh DVT clinical trial. The cancer patients with deep venous thrombosis (DVT) and without pulmonary embolism (PE) were randomised to standard treatment or a once-weekly subcutaneous injection of idraparinux (2.5 mg), a synthetic pentasaccharide. 421 cancer patients were included. A total of 220 patients received idraparinux and 201 were allocated to standard therapy for three months (8%) or six months (92%). A recurrent VTE was observed during the first six months in 2.5% (n=5) of the idraparinux recipients compared to 6.4% (n=12) in the standard therapy group (hazard ratio 0.39, 95% confidence interval [CI]; 0.14-1.11). The rate of bleeding was comparable (odds ratio 0.89, 95% CI; 0.50-1.59). The outcomes were similar at three months after randomisation in all patients. Of the idraparinux recipients, 22.7% (n=50) died during the study period compared to 48 patients (23.9%) in the standard treatment group (hazard ratio 0.99, 95% CI; 0.66-1.48). In conclusion, no significant safety or survival differences were observed between cancer patients with DVT treated with idraparinux for six months compared to standard therapy. Fewer recurrent VTEs were observed in the idraparinux group; however, this was not statistically significant and also because of study limitations this should be interpreted with caution.
KW - Anticoagulation
KW - Cancer
KW - Deep venous thrombosis
KW - Idraparinux
UR - http://www.scopus.com/inward/record.url?scp=77954375788&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=77954375788&partnerID=8YFLogxK
U2 - 10.1160/TH09-12-0870
DO - 10.1160/TH09-12-0870
M3 - Article
C2 - 20508907
AN - SCOPUS:77954375788
VL - 104
SP - 86
EP - 91
JO - Thrombosis and Haemostasis
JF - Thrombosis and Haemostasis
SN - 0340-6245
IS - 1
ER -