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

Sylvia Haas; Alfredo E. Farjat; Karen Pieper; Walter Ageno; Pantep Angchaisuksiri; Henri Bounameaux; Samuel Z. Goldhaber; Shinya Goto; Lorenzo Mantovani; Paolo Prandoni; Sebastian Schellong; Alexander G.G. Turpie; Jeffrey I. Weitz; Peter MacCallum; Hugo ten Cate; Elizaveta Panchenko; Marc Carrier; Carlos Jerjes-Sanchez; Harry Gibbs; Petr Jansky; Gloria Kayani; Ajay K Kakkar; on behalf of the GARFIELD-VTE investigators

doi:10.1055/s-0042-1757744

TH Open, Inhaltsverzeichnis

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

¹Formerly Technical University of Munich, Munich, Germany

,

Alfredo E. Farjat

²Formerly Thrombosis Research Institute, London, United Kingdom

,

Karen Pieper

³Thrombosis Research Institute, London, United Kingdom

,

Walter Ageno

⁴Department of Medicine and Surgery, University of Insubria, Varese, Italy

,

Pantep Angchaisuksiri

⁵Department of Medicine, Ramathibodi Hospital, Mahidol University, Thailand

,

Henri Bounameaux

⁶Department of Medicine, University of Geneva, Switzerland

,

Samuel Z. Goldhaber

⁷Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, United States

,

Shinya Goto

⁸Department of Medicine (Cardiology), Tokai University School of Medicine, Japan

,

Lorenzo Mantovani

⁹Center for Public Health Research, University of Milan-Bicocca, Monza, Italy

,

Paolo Prandoni

¹⁰Arianna Foundation on Anticoagulation, Bologna, Italy

,

Sebastian Schellong

¹¹Department of Health Sciences, Medical Department 2, Municipal Hospital Dresden, Germany

,

Alexander G.G. Turpie

¹²McMaster University, Hamilton, Canada

,

Jeffrey I. Weitz

¹³Department of Haematology, McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, Ontario, Canada

,

Peter MacCallum

³Thrombosis Research Institute, London, United Kingdom

¹⁴Queen Mary University of London, London, United Kingdom

,

Hugo ten Cate

¹⁵Department of Vascular Medicine and Internal Medicine, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht; Maastricht, The Netherlands

,

Elizaveta Panchenko

¹⁶National Medical Research Center of Cardiology of Ministry of Health of the Russian Federation, Moscow, Russian Federation

,

Marc Carrier

¹⁷Department of Medicine, The Ottawa Hospital, Ottawa, Canada

,

Carlos Jerjes-Sanchez

¹⁸Tecnológico de Monterrey. Escuela de Medicina y Ciencias de la Salud., Monterrey, Mexico

¹⁹Instituto de Cardiología y Medicina Vascular, TecSalud, Sa Pedro Garza Garcia, Mexico

,

Harry Gibbs

²⁰Vascular Laboratory, The Alfred Hospital, Melbourne, Australia

,

Petr Jansky

²¹Motol University Hospital, Department of Cardiovascular Surgery, Prague, Czech Republic

,

Gloria Kayani

³Thrombosis Research Institute, London, United Kingdom

,

Ajay K Kakkar

³Thrombosis Research Institute, London, United Kingdom

,

on behalf of the GARFIELD-VTE investigators

› Institutsangaben

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

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Referenzen

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