Characteristics and Management of Patients with Venous Thromboembolism: The GARFIELD-VTE RegistryFunding The GARFIELD-VTE registry is an independent academic research initiative sponsored by the Thrombosis Research Institute (London, United Kingdom) and supported by an unrestricted research grant from Bayer Pharma AG (Berlin, Germany).
10 September 2018
02 November 2018
28 December 2018 (online)
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.
Results 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 (body mass index ≥ 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 AC (DOAC) in 16.4% or a vitamin K antagonist (VKA) in 26.8%. DOACs alone were prescribed to 32.3% of patients, while 5.9% received VKA alone.
Conclusion 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.
Keywordsvenous thromboembolism - registry - deep vein thrombosis - pulmonary embolism - anticoagulation
The lead authors affirm that the manuscript is an honest, accurate and transparent account of the study being reported; that no important aspects of the study have been omitted.
Independent ethics committee and hospital-based institutional review board approvals were obtained, as necessary, for the registry protocol.
* A full list of investigators is given in Supplementary Appendix A available in the online version.
- 1 Heit JA, Cohen AT, Anderson FA. Estimated annual number of incident and recurrent, non-fatal and fatal venous thromboembolism (VTE) events in the US. Blood 2005; 106 (11) 910
- 2 Cohen AT, Agnelli G, Anderson FA. , et al; VTE Impact Assessment Group in Europe (VITAE). Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality. Thromb Haemost 2007; 98 (04) 756-764
- 3 ISTH Steering Committee for World Thrombosis Day. Thrombosis: a major contributor to global disease burden. Thromb Res 2014; 134 (05) 931-938
- 4 Anderson Jr FA, Spencer FA. Risk factors for venous thromboembolism. Circulation 2003; 107 (23) (Suppl. 01) I9-I16
- 5 Weitz JI, Haas S, Ageno W. , et al. Global Anticoagulant Registry in the Field - Venous Thromboembolism (GARFIELD-VTE). Rationale and design. Thromb Haemost 2016; 116 (06) 1172-1179
- 6 Bates SM, Jaeschke R, Stevens SM. , et al. Diagnosis of DVT: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (2 Suppl): e351S-e418S
- 7 Cohen AT, Gitt AK, Bauersachs R. , et al. The management of acute venous thromboembolism in clinical practice. Results from the European PREFER in VTE Registry. Thromb Haemost 2017; 117 (07) 1326-1337
- 8 Maestre A, Sánchez R, Rosa V. , et al; RIETE Investigators. Clinical characteristics and outcome of inpatients versus outpatients with venous thromboembolism: findings from the RIETE Registry. Eur J Intern Med 2010; 21 (05) 377-382
- 9 Raskob GE, Angchaisuksiri P, Blanco AN. , et al; ISTH Steering Committee for World Thrombosis Day. Thrombosis: a major contributor to global disease burden. Arterioscler Thromb Vasc Biol 2014; 34 (11) 2363-2371
- 10 Wendelboe AM, McCumber M, Hylek EM, Buller H, Weitz JI, Raskob G. ; ISTH Steering Committee for World Thrombosis Day. Global public awareness of venous thromboembolism. J Thromb Haemost 2015; 13 (08) 1365-1371
- 11 Konstantinides SV, Torbicki A, Agnelli G. , et al; Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J 2014; 35 (43) 3033-3069
- 12 Lecumberri R, Alfonso A, Jiménez D. , et al; RIETE investigators. Dynamics of case-fatality rates of recurrent thromboembolism and major bleeding in patients treated for venous thromboembolism. Thromb Haemost 2013; 110 (04) 834-843
- 13 Ageno W, Mantovani LG, Haas S. , et al. Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep-vein thrombosis (XALIA): an international, prospective, non-interventional study. Lancet Haematol 2016; 3 (01) e12-e21