36-month clinical outcomes of patients with venous thromboembolism: GARFIELD-VTE

GARFIELD-VTE investigators

doi:10.1016/j.thromres.2022.11.016

36-month clinical outcomes of patients with venous thromboembolism: GARFIELD-VTE

GARFIELD-VTE investigators

Department of Internal Medicine

Research output: Contribution to journal › Article › peer-review

Abstract

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.

Original language	English
Pages (from-to)	31-39
Number of pages	9
Journal	Thrombosis Research
Volume	222
DOIs	https://doi.org/10.1016/j.thromres.2022.11.016
State	Published - 1 Feb 2023

Keywords

Anticoagulation
Deep vein thrombosis
Pulmonary embolism
Registry
Venous thromboembolism

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.thromres.2022.11.016

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@article{9c07d917b642413cade074ccac9c47a7,

title = "36-month clinical outcomes of patients with venous thromboembolism: GARFIELD-VTE",

abstract = "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.",

keywords = "Anticoagulation, Deep vein thrombosis, Pulmonary embolism, Registry, Venous thromboembolism",

author = "{GARFIELD-VTE investigators} and Turpie, {Alexander G.G.} and Farjat, {Alfredo E.} and Sylvia Haas and Walter Ageno and Weitz, {Jeffrey I.} and Goldhaber, {Samuel Z.} and Shinya Goto and Pantep Angchaisuksiri and Gloria Kayani and Lopes, {Renato D.} and Chiang, {Chern En} and Harry Gibbs and Peter Verhamme and {ten Cate}, Hugo and Juan Muntaner and Sebastian Schellong and Henri Bounameaux and Paolo Prandoni and Kakkar, {Ajay K.} and Ab Loualidi and Abdurrahim Colak and Abraham Bezuidenhout and Abu Abdool-Carrim and Addala Azeddine and Adriaan Beyers and Adriaan Dees and Ahmed Mohamed and Ahmet Aksoy and Akihiko Abiko and Akinori Watanabe and Alan Krichell and Fernandez, {Alberto Alfredo} and Alberto Tosetto and Alexey Khotuntsov and Alisha Oropallo and Alison Slocombe and Allan Kelly and Amanda Clark and Amr Gad and Amy Arouni and Andor Schmidt and Andrea Berni and Kleiban, {Andres Javier} and Andrew Machowski and Andrey Kazakov and Angel Galvez and Ann Lockman and Anna Falanga and Anoop Chauhan and Mun, {Yeung Chul}",

note = "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: {\textcopyright} 2022 The Authors",

year = "2023",

month = feb,

day = "1",

doi = "10.1016/j.thromres.2022.11.016",

language = "English",

volume = "222",

pages = "31--39",

journal = "Thrombosis Research",

issn = "0049-3848",

publisher = "Elsevier Ltd.",

}

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 -

36-month clinical outcomes of patients with venous thromboembolism: GARFIELD-VTE

Abstract

Keywords

UN SDGs

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