Global Anticoagulant Registry in the Field – Venous Thromboembolism (GARFIELD-VTE)

Summary

Venous thromboembolism (VTE) is a common disorder associated with significant rates of morbidity and mortality. VTE management aims to reduce mortality, the risks of recurrence, and long-term complications. VTE treatment is evolving with the introduction of non-vitamin K antagonist anticoagulants (NOACs). The Global Anticoagulant Registry in the FIELD – Venous Thromboembolism (GARFIELD-VTE) is a prospective, multicentre, observational study that will enrol 10,000 patients treated for acute VTE from ∼500 sites in 28 countries. Identified sites reflect the diversity of care settings, including hospital and outpatient settings. Patients will be managed according to local practices and followed for at least three years. The primary objective is to determine the extent to which VTE treatment varies in the real-world setting and to assess the impact of such variability on clinical and economic outcomes. Evolving patterns of care will be captured using two sequential cohorts. The GARFIELD-VTE registry will provide insights into the evolving global treatment patterns for VTE, both deep-vein thrombosis and pulmonary embolism. By enrolling patients from diverse care settings, the registry will provide information on adherence to national and international guidelines, identify good practice as well as treatment deficiencies, and relate patient outcomes to clinical management. The incidence of death, recurrent VTE, bleeding, post-thrombotic syndrome and chronic thromboembolic pulmonary hypertension will be documented. By capturing information during and after anticoagulation treatment, the registry will not only define aspects of the natural history of VTE, but also its economic and societal impact at a regional and global level.

Keywords

Registry - venous thromboembolism - deep-vein thrombosis - pulmonary embolism - anticoagulation - thrombolysis

• References

• 1 Jha AK, Larizgoitia I, Audera-Lopez C. et al. The global burden of unsafe medical care: analytic modelling of observational studies. BMJ Qual Saf 2013; 22: 809-815.
• 2 Huang W, Goldberg RJ, Anderson FA. et al. Occurrence and predictors of recurrence after a first episode of acute venous thromboembolism: population-based Worcester Venous Thromboembolism Study. J Thromb Thrombolysis 2016; 41: 525-538.
• 3 Martinez C, Cohen AT, Bamber L. et al. Epidemiology of first and recurrent venous thromboembolism: a population-based cohort study in patients without active cancer. Thromb Haemost 2014; 112: 255-263.
• 4 Galanaud JP, Sevestre MA, Genty C. et al. Incidence and predictors of venous thromboembolism recurrence after a first isolated distal deep vein thrombosis. J Thromb Haemost 2014; 12: 436-443.
• 5 Poch DS, Auger WR. Chronic thromboembolic pulmonary hypertension: detection, medical and surgical treatment approach, and current outcomes. Heart Fail Rev 2016; 21: 309-322.
• 6 Heit JA. Venous thromboembolism: disease burden, outcomes and risk factors. J Thromb Haemost 2005; 03: 1611-1617.
• 7 Heit JA, Silverstein MD, Mohr DN. et al. The epidemiology of venous thromboembolism in the community. Thromb Haemost 2001; 86: 452-463.
• 8 Tagalakis V, Patenaude V, Kahn SR. et al. Treatment patterns of venous thromboembolism in a real-world population: the Q-VTE study cohort. Thromb Res 2014; 134: 795-802.
• 9 Cohen A, Chiu KM, Park K. et al. Managing venous thromboembolism in Asia: winds of change in the era of new oral anticoagulants. Thromb Res 2012; 130: 291-301.
• 10 Cohen AT, Agnelli G, Anderson FA. et al. Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality. Thromb Haemost 2007; 98: 756-764.
• 11 Silverstein MD, Heit JA, Mohr DN. et al. Trends in the incidence of deep vein thrombosis and pulmonary embolism: a 25-year population-based study. Arch Intern Med 1998; 158: 585-593.
• 12 Zhu T, Martinez I, Emmerich J. Venous thromboembolism: risk factors for recurrence. Arterioscler Thromb Vasc Biol 2009; 29: 298-310.
• 13 Spencer FA, Gore JM, Lessard D. et al. Patient outcomes after deep vein thrombosis and pulmonary embolism: the Worcester Venous Thromboembolism Study. Arch Intern Med 2008; 168: 425-430.
• 14 Tick LW, Kramer MH, Rosendaal FR. et al. Risk factors for post-thrombotic syndrome in patients with a first deep venous thrombosis. J Thromb Haemost 2008; 06: 2075-2081.
• 15 Kahn SR, Kearon C, Julian JA. et al. Predictors of the post-thrombotic syndrome during long-term treatment of proximal deep vein thrombosis. J Thromb Haemost 2005; 03: 718-723.
• 16 Ruppert A, Steinle T, Lees M. Economic burden of venous thromboembolism: a systematic review. J Med Econ 2011; 14: 65-74.
• 17 Kahn SR, Elman EA, Bornais C. et al. Post-thrombotic syndrome, functional disability and quality of life after upper extremity deep venous thrombosis in adults. Thromb Haemost 2005; 93: 499-502.
• 18 MacDougall DA, Feliu AL, Boccuzzi SJ. et al. Economic burden of deep-vein thrombosis, pulmonary embolism, and post-thrombotic syndrome. Am J Health Syst Pharm 2006; 63: S5-15.
• 19 Pengo V, Lensing AW, Prins MH. et al. Incidence of chronic thromboembolic pulmonary hypertension after pulmonary embolism. N Engl J Med 2004; 350: 2257-2264.
• 20 Konstantinides SV, Torbicki A, Agnelli G. et al. 2014 ESC Guidelines on the diagnosis and management of acute pulmonary embolism. The Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC)Endorsed by the European Respiratory Society (ERS) 2014; 35: 3033-3073.
• 21 Schulman S, Kearon C, Kakkar AK. et al. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med 2009; 361: 2342-2352.
• 22 Buller HR, Prins MH, Lensin AW. et al. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 2012; 366: 1287-1297.
• 23 Agnelli G, Buller HR, Cohen A. et al. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med 2013; 369: 799-808.
• 24 Buller HR, Decousus H, Grosso MA. et al. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med 2013; 369: 1406-1415.
• 25 Bauersachs R, Berkowitz SD, Brenner B. et al. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010; 363: 2499-2510.
• 26 Schulman S, Kakkar AK, Goldhaber SZ. et al. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation 2014; 129: 764-772.
• 27 Yamada N, Hirayama A, Maeda H. et al. Oral rivaroxaban for Japanese patients with symptomatic venous thromboembolism - the J-EINSTEIN DVT and PE program. Thromb J 2015; 13: 2.
• 28 Cano SJ, Lamping DL, Bamber L. et al. The Anti-Clot Treatment Scale (ACTS) in clinical trials: cross-cultural validation in venous thromboembolism patients. Health Qual Life Outcomes 2012; 10: 12.
• 29 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; 03: e12-21.
• 30 Robertson L, Kesteven P, McCaslin JE. Oral direct thrombin inhibitors or oral factor Xa inhibitors for the treatment of pulmonary embolism. Cochrane Database Syst Rev 2015; 12: Cd01095.
• 31 Cohen AT, Hamilton M, Mitchell SA. et al. Comparison of the Novel Oral Anticoagulants Apixaban, Dabigatran, Edoxaban, and Rivaroxaban in the Initial and Long-Term Treatment and Prevention of Venous Thromboembolism: Systematic Review and Network Meta-Analysis. PLoS One 2015; 10: e014485.
• 32 Frank B, Ariza L, Lamparter H. et al. Rationale and design of three observational, prospective cohort studies including biobanking to evaluate and improve diagnostics, management strategies and risk stratification in venous thromboembolism: the VTEval Project. BMJ Open 2015; 05: e00815.
• 33 Agnelli G, Gitt AK, Bauersachs R. et al. The management of acute venous thromboembolism in clinical practice - study rationale and protocol of the European PREFER in VTE Registry. Thromb J 2015; 13: 41.
• 34 Tzoran I, Brenner B, Papadakis M. et al. VTE Registry: What Can Be Learned from RIETE?. Rambam Maimonides Med J 2014; 05: e0037.
• 35 Beyer-Westendorf J, Forster K, Pannach S. et al. Rates, management, and outcome of rivaroxaban bleeding in daily care: results from the Dresden NOAC registry. Blood 2014; 124: 955-962.