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 - Riera-Mestre, Antoni
AU - Mazzone, Antonino
AU - D'Angelo, Armando
AU - Herdy, Artur
AU - Kato, Atsushi
AU - Salem, Ayman Abd Elhamid Ebrahim Mahmoud
AU - Husin, Azlan
AU - Erdelyi, Barbara
AU - Jacobson, Barry
AU - Amann-Vesti, Beatrice
AU - Battaloglu, Bektas
AU - Wilson, Benedicte
AU - Cosmi, Benilde
AU - Francois, Bergmann Jean
AU - Toufek, Berremeli
AU - Hunt, Beverley
AU - Natha, Bhavesh
AU - Mustafa, Bisher
AU - Kho, Bonnie Chi Shan
AU - Carine, Boulon
AU - Zidel, Brian
AU - Dominique, Brisot
AU - Christophe, Brousse
AU - Trimarco, Bruno
AU - Luo, Canhua
AU - Cuneo, Carlos Alberto
AU - Diaz, Carlos Jerjes Sanchez
AU - Schwencke, Carsten
AU - Cader, Cas
AU - Yavuz, Celal
AU - Zaidman, Cesar Javier
AU - Lunn, Charles
AU - Wu, Chau Chung
AU - Toh, Cheng Hock
AU - Elisa, Chevrier
AU - Hsia, Chien Hsun
AU - Huang, Chien Lung
AU - Kwok, Chi Hang Kevin
AU - Wu, Chih Cheng
AU - Huang, Chi Hung
AU - Ward, Chris
AU - Opitz, Christian
AU - Jeanneret-Gris, Christina
AU - Ha, Chung Yin
AU - Huang, Chun Yao
AU - Bidi, Claude Luyeye
AU - Smith, Clifford
AU - Brauer, Cornelia
AU - Lodigiani, Corrado
AU - Francis, Couturaud
AU - Wu, Cynthia
AU - Staub, Daniel
AU - Theodoro, Daniel
AU - Poli, Daniela
AU - Acevedo, David Riesco
AU - Adler, David
AU - Jimenez, David
AU - Keeling, David
AU - Scott, David
AU - Imberti, Davide
AU - Creagh, Desmond
AU - Helene, Desmurs Clavel
AU - Hagemann, Dirk
AU - Le Roux, Dirk
AU - Skowasch, Dirk
AU - Belenky, Dmitry
AU - Dorokhov, Dmitry
AU - Petrov, Dmitry
AU - Zateyshchikov, Dmitry
AU - Prisco, Domenico
AU - Møller, Dorthe
AU - Kucera, Dusan
AU - Esheiba, Ehab M.
AU - Panchenko, Elizaveta
AU - Dominique, Elkouri
AU - Dogan, Emre
AU - Kubat, Emre
AU - Diaz, Enrique Diaz
AU - Tse, Eric Wai Choi
AU - Yeo, Erik
AU - Hashas, Erman
AU - Grochenig, Ernst
AU - Tiraferri, Eros
AU - Blessing, Erwin
AU - Michèle, Escande Orthlieb
AU - Usandizaga, Esther
AU - Porreca, Ettore
AU - Ferroni, Fabian
AU - Nicolas, Falvo
AU - Ayala-Paredes, Félix
AU - Koura, Firas
AU - Henry, Fitjerald
AU - Cosmi, Franco
AU - Erdkamp, Frans
AU - Kamalov, Gadel
AU - Dalmau, Garcia Bragado
AU - Damien, Garrigues
AU - Klein, Garry
AU - Shah, Gaurand
AU - Hollanders, Geert
AU - Merli, Geno
AU - Plassmann, Georg
AU - Platt, George
AU - Poirier, Germain
AU - Sokurenko, German
AU - Haddad, Ghassan
AU - Ali, Gholam
AU - Agnelli, Giancarlo
AU - Gan, Gin Gin
AU - Kaye-Eddie, Grace
AU - Le Gal, Gregoire
AU - Allen, Gregory
AU - Esperón, Guillermo Antonio Llamas
AU - Jean-Paul, Guillot
AU - Gerofke, Hagen
AU - Elali, Hallah
AU - Burianova, Hana
AU - Ohler, Hans Juergen
AU - Wang, Haofu
AU - Darius, Harald
AU - Gogia, Harinder S.
AU - Striekwold, Harry
AU - Hasanoglu, Hatice
AU - Turker, Hatice
AU - Franow, Hendrik
AU - De Raedt, Herbert
AU - Schroe, Herman
AU - ElDin, Hesham Salah
AU - Zidan, Hesham
AU - Nakamura, Hiroaki
AU - Kim, Ho Young
AU - Lawall, Holger
AU - Zhu, Hong
AU - Tian, Hongyan
AU - Yhim, Ho Young
AU - Hwang, Hun Gyu
AU - Shim, Hyeok
AU - Kim, Igor
AU - Libov, Igor
AU - Sonkin, Igor
AU - Suchkov, Igor
AU - Song, Ik Chan
AU - Kiris, Ilker
AU - Staroverov, Ilya
AU - Looi, Irene
AU - De La Azuela Tenorio, Isabel M.
AU - Savas, Ismail
AU - Gordeev, Ivan
AU - Podpera, Ivo
AU - Lee, Jae Hoon
AU - Sathar, Jameela
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 -