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Thromb Haemost 2024; 124(07): 676-683
DOI: 10.1055/s-0043-1778642
Stroke, Systemic or Venous Thromboembolism

Early Time Courses of Recurrent Venous Thromboembolism and Bleeding during Apixaban or Dalteparin Therapy for Patients with Cancer

Alexander T. Cohen
1   Department of Haemostasis and Thrombosis, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom
,
Katherine J. Creeper 
1   Department of Haemostasis and Thrombosis, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom
2   Haematology Department, Sir Charles Gairdner Hospital, Perth, Australia
3   Haematology Department, PathWest Laboratory Medicine, Nedlands, Australia
,
Raza Alikhan
4   Haematology Department, University Hospital Wales, Cardiff, United Kingdom
,
Chaozer Er 
5   Department of General Medicine, Woodlands Health, Singapore, Singapore
,
Jean M. Connors
6   Heart and Vascular Center, Brigham and Women's Hospital, Boston, Massachusetts, United States
,
Menno V. Huisman
7   Department of Medicine – Thrombosis and Hemostasis, Leiden University Medical Center, Leiden and Dutch Thrombosis Network, The Netherlands
,
Andres Munoz
8   Department of Medical Oncology, Gregorio Marañón Health Research Institute, Complutense University, Madrid, Spain
,
Giorgio Vescovo
9   Department of internal medicine, Ospedale sant Antonio, Padua, Italy
,
Rupert Bauersachs 
10   Cardioangiologic Center Bethanien, CCB, Frankfurt, Germany
11   Center of Thrombosis and Hemostasis, University Mainz, Mainz, Germany
,
Walter Ageno
12   Dipartimento di Medicina e Chirurgia, Università degli Studi dell'Insubria, Varese, Italy
,
Giancarlo Agnelli
9   Department of internal medicine, Ospedale sant Antonio, Padua, Italy
,
Cecilia Becattini
9   Department of internal medicine, Ospedale sant Antonio, Padua, Italy
› Author Affiliations Funding K.J.C. received a new investigator clinical fellowship grant from the Haematology Society of Australia and New Zealand (HSANZ).
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Abstract

Background In patients with acute venous thromboembolism (VTE), the rates of recurrence and major bleeding are highest during the first weeks of anticoagulation. The CARAVAGGIO trial demonstrated noninferiority of apixaban to dalteparin for treatment of cancer-associated VTE without an increased risk of major bleeding. We compared the early time course of VTE recurrence and major bleeding events of apixaban compared with dalteparin at 7, 30, and 90 days of treatment in patients with cancer-associated VTE.

Methods The study design of the CARAVAGGIO trial has been described. Eligible patients were randomly assigned to receive monotherapy with either apixaban or dalteparin for 6 months. The primary efficacy outcome was the incidence of objectively confirmed recurrent VTE. The primary safety outcome was major bleeding.

Results In 1,155 patients, recurrent VTE after 7, 30, and 90 days occurred in 6 (1%), 15 (2.6%), and 27 (4.7%) patients in the apixaban arm versus 5 (0.9%), 20 (3.5%), and 36 (6.2%) patients respectively in the dalteparin arm. By day 7, 30, and 90, major bleeding events had occurred in 3 (0.5%), 9 (1.6%), and 16 (2.8%) patients in the apixaban group versus 5 (0.9%), 11 (1.9%), and 17 (2.9%) patients in the dalteparin group.

Conclusion The frequencies of recurrent VTE and major bleeding events at 7, 30, and 90 days of apixaban compared with dalteparin were similar in patients with cancer-associated VTE. This supports the use of apixaban for the initiation and early phase of anticoagulant therapy in cancer-associated VTE.

Keywords

anticoagulants - bleeding - cancer - dalteparin - thrombosis

Authors' Contribution

A.T.C. was responsible for study design, data review, and writing and reviewing the manuscript. K.J.C. was responsible for data review, and writing and reviewing of the manuscript. R.A. was responsible for data and manuscript review. All authors had access to the data and had final responsibility for the decision to submit for publication.


Supplementary Material



Publication History

Received: 02 August 2023

Accepted: 12 December 2023

Article published online:
09 January 2024

© 2024. Thieme. All rights reserved.

Georg Thieme Verlag KG
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