Heparin based prophylaxis to prevent venous thromboembolic events and death in patients with cancer - a subgroup analysis of CERTIFY
1 Institut für Experimentelle Onkologie und Therapieforschung, Technische Universität München, Germany
2 Abteilung für Angiologie, Klinikum Friedrichstadt, Dresden, Germany
3 Abteilung für Kardiologie, Klinikum Lippe-Detmold, Detmold, Germany
4 Phlebology Unit, General Medical Centre, Mannheim, Germany
5 Max-Ratschow-Klinik für Angiologie, Klinikum Darmstadt GmbH, Darmstadt, Germany
6 Clinical Research, Novartis Pharma GmbH, Nürnberg, Germany
7 Biostatistics, Novartis Pharma GmbH, Nürnberg, Germany
8 Institute for Cardiovascular Pharmacology and Epidemiology, Mahlow, Germany
9 Medical Clinic Hematology/Oncology, Charité Campus Virchow Klinikum, Augustenburger Platz 1, Berlin, 13353, Germany
BMC Cancer 2011, 11:316 doi:10.1186/1471-2407-11-316Published: 26 July 2011
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.
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.
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).
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.