Characteristics and Management of Patients with Venous Thromboembolism: The GARFIELD-VTE Registry

Background: Management of venous thromboembolism (VTE), encompassing both deep-vein thrombosis (DVT) and pulmonary embolism (PE), varies worldwide. Methods: The Global Anticoagulant Registry in the FIELD - Venous Thromboembolism (GARFIELD-VTE) is a prospective, observational study of 10,685 patients with objectively diagnosed VTE recruited from May 2014 to January 2017 at 417 sites in 28 countries. All patients are followed for at least 3 years. We describe the baseline characteristics of the study population and their management within 30 days of diagnosis. Findings: The median age was 60.2 years; 50.4% were male; 61.7% had DVT and 38.3% had PE ± DVT and 32.3% were obese (BMI≥30 kg/m2). The most common risk factors were surgery (12.5%), hospitalization (12.0%), and trauma to the lower limbs (7.8%). At the time of VTE diagnosis, 10.1% had active cancer and 5.7% were chronically immobilized. Treatment for VTE was anticoagulant (AC) therapy alone in 90.9% of patients; 5.1% received thrombolytic and/or surgical/mechanical therapy ± AC and 4.0% received no therapy. Pre-diagnosis, 12.8% received AC therapy alone and 0.2% received thrombolytic and/or surgical/mechanical therapy ± AC. After diagnosis, parenteral AC therapy alone was administered in 17.6% of patients, and it was followed by a direct oral anticoagulant (DOAC) in 16.4% or a vitamin K antagonist (VKA) in 26.8%. DOACs alone were prescribed to 32.3% of patients; 5.9% received VKA alone. Interpretation: The initial findings from this global registry highlight the heterogeneity in characteristics and management of VTE patients. Prospective follow-up will reveal the impact of this heterogeneity on outcomes. Interpretation: The initial findings from this global registry highlight the heterogeneity in characteristics and management of VTE patients. Prospective follow-up will reveal the impact of this heterogeneity on outcomes. Clinical Trial Number: (ClinicalTrials.gov identifier: NCT02155491) Funding Statement: The GARFIELD-VTE Registry is an independent academic research initiative sponsored by the Thrombosis Research Institute (London, UK) and supported by an unrestricted research grant from Bayer Pharma AG (Berlin, Germany). Declaration of Interests: Walter Ageno: Honoraria from Boehringer Ingelheim, Bayer Pharmaceuticals, BMS-Pfizer and Daiichi-Sankyo. Research support from Bayer Pharmaceuticals and Boehringer Ingelheim. Sylvia Haas: Honoraria from Aspen, Bayer Healthcare, BMS, Daiichi-Sankyo, Pfizer, Portola, Sanofi. Jeffrey I. Weitz: Honoraria from Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi-Sankyo, Ionis, Janssen, Merck, Portola, Pfizer, Servier and Novartis. Samuel Z. Goldhaber: Grants from BiO2 Medical, Boehringer-Ingelheim, Bristol Meyers Squibb, BTG EKOS, Daiichi-Sankyo, National Heart Lung and Blood Institute of the National Institutes of Health, Janssen and the Thrombosis Research Group. Personal fees (all consultancy less than $10k) from Bayer, Boehringer-Ingelheim, Bristol Meyers Squibb, Daiichi-Sankyo, Janssen, Portola, Zafgen. Alexander G. G. Turpie: Personal fees from Bayer Pharma AG, Janssen. Shinya Goto: Honoraria from Sanofi, AstraZeneca and Bayer. Research funding from Sanofi. Sebastian Schellong: Speaker fees from Bayer Healthcare, Boehringer Ingelheim, Bristol Meyer Squibb, Daiichi-Sankyo, Sanofi Aventis and Pfizer. Consultancy fees from Bayer Healthcare, Boehringer Ingelheim, Daiichi-Sankyo, Sanofi Aventis and Pfizer. Joern Dalsgaard Nielsen: Honoraria from Bayer, Boehringer-Ingelheim, Bristol Myers Squibb, Leo Pharma and Pfizer. Henri Bounameaux: Research grant, speaker’s fees and honoraria for studies with rivaroxaban from Bayer Healthcare. Honoraria from Sanofi. Lorenzo Mantovani: Grants and personal fees from Bayer Healthcare, Boehringer Ingelheim, Pfizer and Daiichi-Sankyo. Paolo Prandoni: Personal fees from Bayer Pharma, Pfizer, Daiichi-Sankyo, Sanofi and Rovi Pharmaceuticos. Professor Ajay K Kakkar is a principal investigator and received research Grants from Bayer Healthcare; he received personal fee from Bayer Healthcare, Boehringer-Ingelheim Pharma, Daiichi-Sankyo Europe, Sanofi SA and Janssen Pharma. Pantep Angchaisuksiri, Karen Pieper and Gloria Kayani declare that they have no conflicts of interest in the research. Ethics Approval Statement: Independent ethics committee for each participating country and the hospital-based institutional review board approved the design of the registry. All patients provided written informed consent to participate.