TY - JOUR
T1 - 36-month clinical outcomes of patients with venous thromboembolism
T2 - GARFIELD-VTE
AU - GARFIELD-VTE investigators
AU - Turpie, Alexander G.G.
AU - Farjat, Alfredo E.
AU - Haas, Sylvia
AU - Ageno, Walter
AU - Weitz, Jeffrey I.
AU - Goldhaber, Samuel Z.
AU - Goto, Shinya
AU - Angchaisuksiri, Pantep
AU - Kayani, Gloria
AU - Lopes, Renato D.
AU - Chiang, Chern En
AU - Gibbs, Harry
AU - Verhamme, Peter
AU - ten Cate, Hugo
AU - Muntaner, Juan
AU - Schellong, Sebastian
AU - Bounameaux, Henri
AU - Prandoni, Paolo
AU - Kakkar, Ajay K.
AU - Loualidi, Ab
AU - Colak, Abdurrahim
AU - Bezuidenhout, Abraham
AU - Abdool-Carrim, Abu
AU - Azeddine, Addala
AU - Beyers, Adriaan
AU - Dees, Adriaan
AU - Mohamed, Ahmed
AU - Aksoy, Ahmet
AU - Abiko, Akihiko
AU - Watanabe, Akinori
AU - Krichell, Alan
AU - Fernandez, Alberto Alfredo
AU - Tosetto, Alberto
AU - Khotuntsov, Alexey
AU - Oropallo, Alisha
AU - Slocombe, Alison
AU - Kelly, Allan
AU - Clark, Amanda
AU - Gad, Amr
AU - Arouni, Amy
AU - Schmidt, Andor
AU - Berni, Andrea
AU - Kleiban, Andres Javier
AU - Machowski, Andrew
AU - Kazakov, Andrey
AU - Galvez, Angel
AU - Lockman, Ann
AU - Falanga, Anna
AU - Chauhan, Anoop
AU - Mun, Yeung Chul
N1 - Funding Information:
GARFIELD-VTE is a non-interventional, prospective, multicentre, observational registry designed to capture real-world outcomes of patients with acute VTE. The study design for GARFIELD-VTE has been described previously [9] and the registry was funded by an unrestricted research grant from Bayer AG. Men and women ≥18 years of age with an objectively confirmed diagnosis of VTE within 30 days of entry into the registry were eligible for inclusion. Patients with recurrent VTE must have completed treatment for the previous VTE episode. Those with superficial vein thrombosis or participating in an interventional study that dictated treatments, or for whom long-term follow up was not possible were excluded. Patients were managed according to local practices; no specific treatments, tests, or procedures were mandated by the protocol. Decisions to initiate, continue or change treatment were solely at the discretion of the treating physicians and their patients.
Publisher Copyright:
© 2022 The Authors
PY - 2023/2/1
Y1 - 2023/2/1
N2 - Background: Venous thromboembolism (VTE), encompassing both deep vein thrombosis (DVT) and pulmonary embolism (PE), is a leading cause of morbidity and mortality worldwide. Methods: GARFIELD-VTE is a prospective, non-interventional observational study of real-world treatment practices. We aimed to capture the 36-month clinical outcomes of 10,679 patients with objectively confirmed VTE enrolled between May 2014 and January 2017 from 415 sites in 28 countries. Findings: A total of 6582 (61.6 %) patients had DVT alone, 4097 (38.4 %) had PE ± DVT. At baseline, 98.1 % of patients received anticoagulation (AC) with or without other modalities of therapy. The proportion of patients on AC therapy decreased over time: 87.6 % at 3 months, 73.0 % at 6 months, 54.2 % at 12 months and 42.0 % at 36 months. At 12-months follow-up, the incidences (95 % confidence interval [CI]) of all-cause mortality, recurrent VTE and major bleeding were 6.5 (7.0–8.1), 5.4 (4.9–5.9) and 2.7 (2.4–3.0) per 100 person-years, respectively. At 36-months, these decreased to 4.4 (4.2–4.7), 3.5 (3.2–2.7) and 1.4 (1.3–1.6) per 100 person-years, respectively. Over 36-months, the rate of all-cause mortality and major bleeds were highest in patients treated with parenteral therapy (PAR) versus oral anti-coagulants (OAC) and no OAC, and the rate of recurrent VTE was highest in patients on no OAC versus those on PAR and OAC. The most frequent cause of death after 36-month follow-up 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 = 564, 63.3 %), with the remainder PE, (n = 236, 27.3 %), or PE in combination with DVT (n = 63, 7.3 %). Interpretation: GARFIELD-VTE provides a global perspective of anticoagulation patterns and highlights the accumulation of events within the first 12 months after diagnosis. These findings may help identify treatment gaps for subsequent interventions to improve patient outcomes in this patient population.
AB - Background: Venous thromboembolism (VTE), encompassing both deep vein thrombosis (DVT) and pulmonary embolism (PE), is a leading cause of morbidity and mortality worldwide. Methods: GARFIELD-VTE is a prospective, non-interventional observational study of real-world treatment practices. We aimed to capture the 36-month clinical outcomes of 10,679 patients with objectively confirmed VTE enrolled between May 2014 and January 2017 from 415 sites in 28 countries. Findings: A total of 6582 (61.6 %) patients had DVT alone, 4097 (38.4 %) had PE ± DVT. At baseline, 98.1 % of patients received anticoagulation (AC) with or without other modalities of therapy. The proportion of patients on AC therapy decreased over time: 87.6 % at 3 months, 73.0 % at 6 months, 54.2 % at 12 months and 42.0 % at 36 months. At 12-months follow-up, the incidences (95 % confidence interval [CI]) of all-cause mortality, recurrent VTE and major bleeding were 6.5 (7.0–8.1), 5.4 (4.9–5.9) and 2.7 (2.4–3.0) per 100 person-years, respectively. At 36-months, these decreased to 4.4 (4.2–4.7), 3.5 (3.2–2.7) and 1.4 (1.3–1.6) per 100 person-years, respectively. Over 36-months, the rate of all-cause mortality and major bleeds were highest in patients treated with parenteral therapy (PAR) versus oral anti-coagulants (OAC) and no OAC, and the rate of recurrent VTE was highest in patients on no OAC versus those on PAR and OAC. The most frequent cause of death after 36-month follow-up 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 = 564, 63.3 %), with the remainder PE, (n = 236, 27.3 %), or PE in combination with DVT (n = 63, 7.3 %). Interpretation: GARFIELD-VTE provides a global perspective of anticoagulation patterns and highlights the accumulation of events within the first 12 months after diagnosis. These findings may help identify treatment gaps for subsequent interventions to improve patient outcomes in this patient population.
KW - Anticoagulation
KW - Deep vein thrombosis
KW - Pulmonary embolism
KW - Registry
KW - Venous thromboembolism
UR - http://www.scopus.com/inward/record.url?scp=85144538710&partnerID=8YFLogxK
U2 - 10.1016/j.thromres.2022.11.016
DO - 10.1016/j.thromres.2022.11.016
M3 - Article
C2 - 36565677
AN - SCOPUS:85144538710
SN - 0049-3848
VL - 222
SP - 31
EP - 39
JO - Thrombosis Research
JF - Thrombosis Research
ER -