Henri Bounameaux1, Sylvia Haas2, Alfredo E Farjat3, Walter Ageno4, Jeffrey I Weitz5, Samuel Z Goldhaber6, Alexander G G Turpie7, Shinya Goto8, Pantep Angchaisuksiri9, Joern Dalsgaard Nielsen10, Gloria Kayani3, Sebastian Schellong11, Lorenzo G Mantovani12, Paolo Prandoni13, Ajay K Kakkar14. 1. Faculty of Medicine, University of Geneva, Switzerland. Electronic address: henri.bounameaux@unige.ch. 2. Formerly Technical University of Munich, Munich, Germany. 3. Thrombosis Research Institute, London, United Kingdom. 4. Department of Medicine and Surgery, University of Insubria, Varese, Italy. 5. McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, Ontario, Canada. 6. Brigham and Women's Hospital and Harvard Medical School, Boston, USA. 7. McMaster University, Hamilton, Canada. 8. Department of Medicine (Cardiology), Tokai University School of Medicine, Japan. 9. Department of Medicine, Ramathibodi Hospital, Mahidol University, Thailand. 10. Copenhagen University Hospital, Denmark. 11. Medical Department 2, Municipal Hospital Dresden, Germany. 12. IRCCS Multimedica, Sesto San Giovanni, Italy; University of Milano-Bicocca, Milan Italy. 13. Arianna Foundation on Anticoagulation, Bologna, Italy. 14. Thrombosis Research Institute, London, United Kingdom; University College London, London, United Kingdom.
Abstract
INTRODUCTION: Randomized controlled trials have shown that direct oral anticoagulants (DOACs) are a safe and effective alternative to vitamin K antagonists (VKAs) for the treatment of venous thromboembolism (VTE). However, there are limited post-marketing data describing the effectiveness and safety of the DOACs in the community setting. We aimed to compare the effectiveness of DOACs and VKAs on 12-month outcomes in a real-world VTE patient population. METHODS: The Global Anticoagulant Registry in the FIELD (GARFIELD)-VTE is an observational study designed to document real-world treatment practices. This intention-to-treat analysis included 7987 VTE patients initiated on either DOACs (N = 4791) or VKAs (N = 3196) with or without pre-treatment with parenteral anticoagulants. Treatment groups were balanced according to baseline characteristics, using overlapping propensity score weights. RESULTS: After adjustment for baseline characteristics, all-cause mortality was significantly lower with DOAC than with VKAs (hazard ratio [HR]: 0.73; 95% confidence interval [CI] 0.56-0.95. Patients receiving VKAs were more likely than those receiving DOACs to die of complications of VTE (4.7% vs 2.7%) or from bleeding (4.2% vs. 1.3%). There was no significant difference in recurrent VTE (HR: 0.91, 95% CI 0.71-1.18), major bleeding (HR 1.03, 95% CI 0.69-1.54), or overall bleeding (HR 0.96, 95% CI 0.81-1.14) with DOACs or VKAs. CONCLUSIONS: n this real-world analysis of VTE treatment, DOACs were associated with reduced all-cause mortality compared with VKAs, and similar rates of recurrent VTE and bleeding.
INTRODUCTION: Randomized controlled trials have shown that direct oral anticoagulants (DOACs) are a safe and effective alternative to vitamin K antagonists (VKAs) for the treatment of venous thromboembolism (VTE). However, there are limited post-marketing data describing the effectiveness and safety of the DOACs in the community setting. We aimed to compare the effectiveness of DOACs and VKAs on 12-month outcomes in a real-world VTEpatient population. METHODS: The Global Anticoagulant Registry in the FIELD (GARFIELD)-VTE is an observational study designed to document real-world treatment practices. This intention-to-treat analysis included 7987 VTEpatients initiated on either DOACs (N = 4791) or VKAs (N = 3196) with or without pre-treatment with parenteral anticoagulants. Treatment groups were balanced according to baseline characteristics, using overlapping propensity score weights. RESULTS: After adjustment for baseline characteristics, all-cause mortality was significantly lower with DOAC than with VKAs (hazard ratio [HR]: 0.73; 95% confidence interval [CI] 0.56-0.95. Patients receiving VKAs were more likely than those receiving DOACs to die of complications of VTE (4.7% vs 2.7%) or from bleeding (4.2% vs. 1.3%). There was no significant difference in recurrent VTE (HR: 0.91, 95% CI 0.71-1.18), major bleeding (HR 1.03, 95% CI 0.69-1.54), or overall bleeding (HR 0.96, 95% CI 0.81-1.14) with DOACs or VKAs. CONCLUSIONS: n this real-world analysis of VTE treatment, DOACs were associated with reduced all-cause mortality compared with VKAs, and similar rates of recurrent VTE and bleeding.
Authors: Sylvia Haas; Lorenzo G Mantovani; Reinhold Kreutz; Danja Monje; Jonas Schneider; Elizabeth R Zell; Miriam Tamm; Martin Gebel; Jörg-Peter Bugge; Walter Ageno; Alexander G G Turpie Journal: Res Pract Thromb Haemost Date: 2021-03-20
Authors: Pablo Demelo-Rodríguez; Lucía Ordieres-Ortega; Zichen Ji; Jorge Del Toro-Cervera; Javier de Miguel-Díez; Luis A Álvarez-Sala-Walther; Francisco Galeano-Valle Journal: Eur J Haematol Date: 2021-03-03 Impact factor: 3.674
Authors: Victoria Speed; Jignesh P Patel; Derek Cooper; Stephen Miller; Lara N Roberts; Raj K Patel; Roopen Arya Journal: Res Pract Thromb Haemost Date: 2021-10-21