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
Affiliations
Sylvia Haas
Formerly Technical University of Munich, Munich, Germany
Alfredo E. Farjat
Formerly Thrombosis Research Institute, London, United Kingdom
Karen Pieper
Thrombosis Research Institute, London, United Kingdom
Walter Ageno
Department of Medicine and Surgery, University of Insubria, Varese, Italy
Pantep Angchaisuksiri
Department of Medicine, Ramathibodi Hospital, Mahidol University, Thailand
Henri Bounameaux
Department of Medicine, University of Geneva, Switzerland
Samuel Z. Goldhaber
Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, United States
Shinya Goto
Department of Medicine (Cardiology), Tokai University School of Medicine, Japan
Lorenzo Mantovani
Center for Public Health Research, University of Milan-Bicocca, Monza, Italy
Paolo Prandoni
Arianna Foundation on Anticoagulation, Bologna, Italy
Sebastian Schellong
Department of Health Sciences, Medical Department 2, Municipal Hospital Dresden, Germany
Alexander G.G. Turpie
McMaster University, Hamilton, Canada
Jeffrey I. Weitz
Department of Haematology, McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, Ontario, Canada
Peter MacCallum
Thrombosis Research Institute, London, United Kingdom
Hugo ten Cate
Department of Vascular Medicine and Internal Medicine, Maastricht University Medical Center and Cardiovascular Research Institute Maastricht; Maastricht, The Netherlands
Elizaveta Panchenko
National Medical Research Center of Cardiology of Ministry of Health of the Russian Federation, Moscow, Russian Federation
Marc Carrier
Department of Medicine, The Ottawa Hospital, Ottawa, Canada
Carlos Jerjes-Sanchez
Tecnológico de Monterrey. Escuela de Medicina y Ciencias de la Salud., Monterrey, Mexico
Harry Gibbs
Vascular Laboratory, The Alfred Hospital, Melbourne, Australia
Petr Jansky
Motol University Hospital, Department of Cardiovascular Surgery, Prague, Czech Republic
Gloria Kayani
Thrombosis Research Institute, London, United Kingdom
Ajay K Kakkar
Thrombosis Research Institute, London, United Kingdom
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.
