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

Sylvia Haas,Ulrich Tebbe,Christian Sieder,Peter Bramlage,Rupert Bauersachs,Claudia Abletshauser,Horst-Eberhard Gerlach,Hanno Riess,Nima Melzer,Sebastian M Schellong

doi:10.1186/1471-2407-11-316

Abstract

BackgroundPatients 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.MethodsAcutely-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.Results1) 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).ConclusionsCertoparin 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 Registrationclinicaltrials.gov, NCT00451412

Highlights

Patients with cancer have an increased risk of venous thromboembolism (VTE)
Patients with cancer have a sixfold increased risk of venous thromboembolism (VTE) compared to those without [1,2], and active cancer accounts for about 20% of all new VTE events occurring in the community [3]
The German guidelines state that additional studies are needed to resolve this controversy and to clarify which anticoagulant regimes are most likely to be beneficial [10]. To further explore this issue we did a post-hoc analysis of the CERToparIn For thromboprophYlaxis in medical patients (CERTIFY) study [24], a trial which included 3,239 hospitalized medical patients of at least 70 years and an expected significant decrease in mobility expected for at least 4 days, of which 274 had cancer at hospital admission

Summary

Introduction

We compared VTE rates and bleeding complications in 1) cancer patients receiving LMWH or UFH and 2) patients with or without cancer. The German guidelines state that additional studies are needed to resolve this controversy and to clarify which anticoagulant regimes are most likely to be beneficial [10] To further explore this issue we did a post-hoc analysis of the CERToparIn For thromboprophYlaxis in medical patients (CERTIFY) study [24], a trial which included 3,239 hospitalized medical patients of at least 70 years and an expected significant decrease in mobility expected for at least 4 days, of which 274 had cancer at hospital admission. We aimed to compare VTE risk and bleeding complications in 1) patients with cancer receiving either LMWH or UFH and 2) patients with or without cancer

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