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CC BY 4.0 · TH Open 2022; 06(04): e354-e364
DOI: 10.1055/s-0042-1757744
Original Article

On-treatment Comparative Effectiveness of Vitamin K Antagonists and Direct Oral Anticoagulants in GARFIELD-VTE, and Focus on Cancer and Renal Disease

Sylvia Haas
1   Formerly Technical University of Munich, Munich, Germany
,
Alfredo E. Farjat
2   Formerly Thrombosis Research Institute, London, United Kingdom
,
Karen Pieper
3   Thrombosis Research Institute, London, United Kingdom
,
Walter Ageno
4   Department of Medicine and Surgery, University of Insubria, Varese, Italy
,
Pantep Angchaisuksiri
5   Department of Medicine, Ramathibodi Hospital, Mahidol University, Thailand
,
Henri Bounameaux
6   Department of Medicine, University of Geneva, Switzerland
,
Samuel Z. Goldhaber
7   Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, United States
,
Shinya Goto 
8   Department of Medicine (Cardiology), Tokai University School of Medicine, Japan
,
Lorenzo Mantovani
9   Center for Public Health Research, University of Milan-Bicocca, Monza, Italy
,
Paolo Prandoni
10   Arianna Foundation on Anticoagulation, Bologna, Italy
,
Sebastian Schellong
11   Department of Health Sciences, Medical Department 2, Municipal Hospital Dresden, Germany
,
Alexander G.G. Turpie
12   McMaster University, Hamilton, Canada
,
Jeffrey I. Weitz
13   Department of Haematology, McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, Ontario, Canada
,
Peter MacCallum
3   Thrombosis Research Institute, London, United Kingdom
14   Queen Mary University of London, London, United Kingdom
,
Hugo ten Cate
15   Department of Vascular Medicine and Internal Medicine, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht; Maastricht, The Netherlands
,
Elizaveta Panchenko
16   National Medical Research Center of Cardiology of Ministry of Health of the Russian Federation, Moscow, Russian Federation
,
Marc Carrier
17   Department of Medicine, The Ottawa Hospital, Ottawa, Canada
,
Carlos Jerjes-Sanchez
18   Tecnológico de Monterrey. Escuela de Medicina y Ciencias de la Salud., Monterrey, Mexico
19   Instituto de Cardiología y Medicina Vascular, TecSalud, Sa Pedro Garza Garcia, Mexico
,
Harry Gibbs
20   Vascular Laboratory, The Alfred Hospital, Melbourne, Australia
,
Petr Jansky
21   Motol University Hospital, Department of Cardiovascular Surgery, Prague, Czech Republic
,
Gloria Kayani
3   Thrombosis Research Institute, London, United Kingdom
,
Ajay K Kakkar
3   Thrombosis Research Institute, London, United Kingdom
,
on behalf of the GARFIELD-VTE investigators › Author Affiliations Funding This work was supported by the Thrombosis Research Institute (London, UK).
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Abstract

Background Direct oral anticoagulants (DOACs) provide a safe, effective alternative to vitamin K antagonists (VKAs) for venous thromboembolism (VTE) treatment, as shown via intention-to-treat comparative effectiveness analysis. However, on-treatment analysis is imperative in observational studies because anticoagulation choice and duration are at investigators' discretion.

Objectives The aim of the study is to compare the effectiveness of DOACs and VKAs on 12-month outcomes in VTE patients using on-treatment analysis.

Methods The Global Anticoagulant Registry in the FIELD - VTE (GARFIELD-VTE) is a world-wide, prospective, non-interventional study observing treatment of VTE in routine clinical practice.

Results In total, 8,034 patients received VKAs (n = 3,043, 37.9%) or DOACs (n = 4,991, 62.1%). After adjustment for baseline characteristics and follow-up bleeding events, and accounting for possible time-varying confounding, all-cause mortality was significantly lower with DOACs than VKAs (hazard ratio: 0.58 [95% confidence interval 0.42–0.79]). Furthermore, patients receiving VKAs were more likely to die of VTE complications (4.9 vs. 2.2%) or bleeding (4.9 vs. 0.0%). There was no significant difference in rates of recurrent VTE (hazard ratio: 0.74 [0.55–1.01]), major bleeding (hazard ratio: 0.76 [0.47–1.24]), or overall bleeding (hazard ratio: 0.87 [0.72–1.05]) with DOACs or VKAs. Unadjusted analyses suggested that VKA patients with active cancer or renal insufficiency were more likely to die than patients treated with DOAC (52.51 [37.33–73.86] vs. 26.52 [19.37–36.29] and 9.97 [7.51–13.23] vs. 4.70 [3.25–6.81] per 100 person-years, respectively).

Conclusion DOACs and VKAs had similar rates of recurrent VTE and major bleeding. However, DOACs were associated with reduced all-cause mortality and a lower likelihood of death from VTE or bleeding compared with VKAs.

Keywords

venous thromboembolism - vitamin K antagonists - direct oral anticoagulants - on-treatment comparative effectiveness - anticoagulation

Supplementary Material



Publication History

Received: 28 April 2022

Accepted: 29 August 2022

Article published online:
03 November 2022

© 2022. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

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