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. Chiang^10,11, H. Gibbs¹², E. Tse¹³, P. Verhamme¹⁴, H. Ten Cate¹⁵, J. Muntaner¹⁶, S. Schellong¹⁷, H. Bounameaux¹⁸, P. Prandoni¹⁹, A.K. Kakkar^2,20

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 January 24, 2022.

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