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Open Access Research article

Heparin based prophylaxis to prevent venous thromboembolic events and death in patients with cancer - a subgroup analysis of CERTIFY

Sylvia Haas1, Sebastian M Schellong2, Ulrich Tebbe3, Horst-Eberhard Gerlach4, Rupert Bauersachs5, Nima Melzer6, Claudia Abletshauser6, Christian Sieder7, Peter Bramlage8 and Hanno Riess9*

Author Affiliations

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

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BMC Cancer 2011, 11:316  doi:10.1186/1471-2407-11-316

Published: 26 July 2011

Abstract

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