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36-month Clinical Outcomes of Patients with Venous Thromboembolism: GARFIELD-VTE

A.G.G. Turpie1, A.E. Farjat2, S. Haas3, W. Ageno4, J.I. Weitz5, S.Z. Goldhaber6, S. Goto7, P. Angchaisuksiri8, G. Kayani2, R.D. Lopes9, C.E. Chiang10,11, H. Gibbs12, E. Tse13, P. Verhamme14, H. Ten Cate15, J. Muntaner16, S. Schellong17, H. Bounameaux18, P. Prandoni19, A.K. Kakkar2,20

1McMaster University, Hamilton, Ontario, Canada, 2Thrombosis Research Institute, London, United Kingdom, 3Formerly Technical University of Munich, Munich, Germany, 4Department of Medicine and Surgery, University of Insubria, Varese, Italy, 5McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, Ontario, Canada, 6Brigham and Women’s Hospital and Harvard Medical School, Boston, United States, 7Department of Medicine (Cardiology), Tokai University School of Medicine, Tokyo, Japan, 8, Department of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand, 9Division of Cardiology, Duke University Medical Center, Duke Clinical Research Institute, Durham, United States, 10General Clinical Research Center, Division of Cardiology, Taipei Veterans General Hospital, Taipei, Taiwan, Province of China, 11National Yang-Ming University, Taipei, Taiwan, Province of China, 12Department of General Medicine, Alfred Health, Melbourne, Australia, 13Department of Medicine, Queen Mary Hospital, Hong Kong Island, Hong Kong, SAR of China, 14Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium, 15Department of Vascular Medicine and Internal Medicine, Maastricht University Medical Center (MUMC+), Maastricht, Netherlands, 16Centro Modelo de Cardiología,Sanatorio Modelo,Facultad de Medicina,Universidad Nacional de Tucuman, Tucumán, Argentina, 17, Medical Department 2, Municipal Hospital Dresden, Dresden, Germany, 18Faculty of Medicine, University of Geneva, Geneva, Switzerland, 19Arianna Foundation on Anticoagulation, Bologna, Italy, 20University College London, London, United Kingdom

Abstract Number: OC 25.3

Meeting: ISTH 2021 Congress

Theme: Venous Thromboembolism » VTE Epidemiology

Background: Venous thromboembolism (VTE), encompassing both deep vein thrombosis (DVT) and pulmonary embolism (PE), is a leading cause of morbidity and mortality worldwide.

Aims: Capture the 36-month clinical outcomes of VTE patients enrolled in the Global Anticoagulant Registry in the FIELD (GARFIELD)-VTE.

Methods: GARFIELD-VTE (ClinicalTrials.gov: NCT02155491) is a global, prospective, non-interventional study of real-world treatment practices. A total of 10,679 patients with objectively confirmed VTE were enrolled between May 2014 and January 2017.

Results: A total of 6582 (61.6%) patients had DVT alone, 4097 (38.4%) had PE ± DVT. At baseline, 98.2% of patients received anticoagulation with or without other modalities of therapy. The proportion of patients receiving anticoagulation decreased over time: 87.6% at 3 months, 73.0% at 6 months, 54.2% at 12 months and 42.0% at 36 months (Figure 1). Within the first year (0-12 months) of follow-up, the rates (95% confidence interval [CI]) of all-cause mortality, recurrent VTE and major bleeding were 7.50 (6.97-8.06), 5.34 (4.89-5.82) and 2.68 (2.37-3.02) per 100 person-years, respectively. These decreased to 3.10 (2.76-3.50), 2.55 (2.23-2.92) and 0.80 (0.63-1.01) per 100 person-years in the second year (13-24 months) and 2.00 (1.72-2.34), 2.08 (1.77-2.43) and 0.48 (0.35-0.66) per 100 person-years in the third year (25-36 months), respectively (Table 1). Over the entire 36-month follow-up, the most frequent cause of death was cancer (n=565, 48.6%), followed by cardiac (n=94, 8.1%) and VTE (n=38, 3.2%). Most recurrent VTE events were DVT alone (n=546, 63.3%), with the remainder PE alone (n=236, 27.3%) or in combination with DVT (n=63, 7.3%). The most common sites of major bleeding were the upper (n=56, 15.4%) or lower (n=59, 16.2%) GI tract.

Conclusions: GARFIELD-VTE provides a global perspective of long term anticoagulation patterns and highlights the accumulation of events within the first 12 months of diagnosis.

Anticoagulation treatment patterns over 36 months’ follow-up in VTE patients. Baseline refers to the first 30 days after VTE diagnosis. Abbreviations: AC; anticoagulant. DOAC; Direct oral anticoagulant. LTFU; lost to follow-up, VKA; Vitamin K antagonist

  Year 1 (0-12 months) Year 2 (13-24 months) Year 3 (25-36 months) Overall (0-36 months)
Endpoint Number of events Rate per 100 person-years (95% CI) Number of events Rate per 100 person-years (95% CI) Number of events Rate per 100 person-years (95% CI) Number of events Rate per 100 person-years (95% CI)
All-cause mortality 732 7.5 (6.97 to 8.06) 270 3.1 (2.75 to 3.5) 159 2.0 (1.72 to 2.34) 1161 4.4 (4.15 to 4.66)
Recurrent VTE 505 5.34 (4.89 to 5.82) 209 2.55 (2.23 to 2.92) 152 2.08 (1.77 to 2.43) 866 3.47 (3.24 to 3.7)
Major bleed 258 2.68 (2.37 to 3.02) 68 0.8 (0.63 to 1.01) 37 0.48 (0.35 to 0.66) 363 1.4 (1.26 to 1.55)
Non-Major bleed 821 8.9 (8.31 to 9.53) 143 1.8 (1.53 to 2.12) 88 1.23 (1 to 1.52) 1052 4.32 (4.07 to 4.59)
Cancer* 259 2.69 (2.38 to 3.03) 106 1.25 (1.03 to 1.51) 72 0.93 (0.74 to 1.18) 437 1.69 (1.54 to 1.86)
Stroke/TIA 69 0.71 (0.56 to 0.9) 50 0.58 (0.44 to 0.76) 39 0.5 (0.36 to 0.68) 158 0.6 (0.52 to 0.7)
MI 70 0.72 (0.57 to 0.91) 26 0.3 (0.2 to 0.44) 33 0.42 (0.3 to 0.59) 129 0.49 (0.41 to 0.58)

Clinical outcomes in VTE patients enrolled in GARFIELD-VTE. *Only cancer events that were diagnosed >30 days from VTE diagnosis date were considered cancer endpoints. Some cases of recurrent VTE included both PE and DVT. Abbreviations: CI; confidence interval, TIA; transient ischemic attack, VTE; venous thromboembolism, MI; myocardial infarction, DVT; deep vein thrombosis, PE; pulmonary embolism.

To cite this abstract in AMA style:

Turpie AGG, Farjat AE, Haas S, Ageno W, Weitz JI, Goldhaber SZ, Goto S, Angchaisuksiri P, Kayani G, Lopes RD, Chiang CE, Gibbs H, Tse E, Verhamme P, Ten Cate H, Muntaner J, Schellong S, Bounameaux H, Prandoni P, Kakkar AK. 36-month Clinical Outcomes of Patients with Venous Thromboembolism: GARFIELD-VTE [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/36-month-clinical-outcomes-of-patients-with-venous-thromboembolism-garfield-vte/. Accessed June 25, 2022.

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