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J Thromb Haemost. 2015 Dec;13(12):2187-91. doi: 10.1111/jth.13153. Epub 2015 Oct 29.

Oral apixaban for the treatment of venous thromboembolism in cancer patients: results from the AMPLIFY trial.

Author information

1
Internal and Cardiovascular Medicine - Stroke Unit, University of Perugia, Perugia, Italy.
2
Department of Vascular Medicine, Academic Medical Center, Amsterdam, the Netherlands.
3
Guy's and St Thomas Hospital's, King's College, London, UK.
4
Department of Haematology, SA Pathology at Flinders Medical Centre & Flinders University, Adelaide, Australia.
5
Pfizer Inc., New York, NY, USA.
6
Pfizer Inc., Groton, CT, USA.
7
College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.
8
McMaster University and Thrombosis and Atherosclerosis Research Institute, Hamilton, Ontario, Canada.

Abstract

BACKGROUND:

The AMPLIFY trial compared apixaban with enoxaparin followed by warfarin for the treatment of acute venous thromboembolism (VTE).

OBJECTIVE:

To perform a subgroup analysis to compare the efficacy and safety of apixaban and enoxaparin followed by warfarin for the treatment of VTE in patients with cancer enrolled in AMPLIFY.

PATIENTS/METHODS:

Patients with symptomatic VTE were randomized to a 6-month course of apixaban or enoxaparin followed by warfarin. The primary efficacy outcome and principal safety outcome were recurrent VTE or VTE-related death and major bleeding, respectively.

RESULTS:

Of the 5395 patients randomized, 169 (3.1%) had active cancer at baseline, and 365 (6.8%) had a history of cancer without active cancer at baseline. Among patients with active cancer, recurrent VTE occurred in 3.7% and 6.4% of evaluable patients in the apixaban and enoxaparin/warfarin groups, respectively (relative risk [RR] 0.56, 95% confidence interval [CI] 0.13-2.37); major bleeding occurred in 2.3% and 5.0% of evaluable patients, respectively (RR 0.45, 95% CI 0.08-2.46). Among patients with a history of cancer, recurrent VTE occurred in 1.1% and 6.3% of evaluable patients in the apixaban and enoxaparin/warfarin groups, respectively (RR 0.17, 95% CI 0.04-0.78); major bleeding occurred in 0.5% and 2.8% of treated patients, respectively (RR 0.20, 95% CI 0.02-1.65).

CONCLUSIONS:

The results of this subgroup analysis suggest that apixaban is a convenient option for cancer patients with VTE. However, additional studies are needed to confirm this concept and to compare apixaban with low molecular weight heparin in these patients.

KEYWORDS:

anticoagulants; apixaban; cancer; enoxaparin; venous thromboembolism

PMID:
26407753
DOI:
10.1111/jth.13153
[Indexed for MEDLINE]
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