36-month clinical outcomes of patients with venous thromboembolism: GARFIELD-VTE.
Autor: | Turpie AGG; McMaster University, Hamilton, Canada. Electronic address: turpiea@mcmaster.ca., Farjat AE; Bayer UK, Reading, United Kingdom., Haas S; Formerly Technical University of Munich, Munich, Germany., Ageno W; Department of Medicine and Surgery, University of Insubria, Varese, Italy., Weitz JI; McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, Ontario, Canada., Goldhaber SZ; Brigham and Women's Hospital and Harvard Medical School, Boston, USA., Goto S; Department of Medicine (Cardiology), Tokai University School of Medicine, Japan., Angchaisuksiri P; Department of Medicine, Ramathibodi Hospital, Mahidol University, Thailand., Kayani G; Thrombosis Research Institute, London, United Kingdom., Lopes RD; Division of Cardiology, Duke University Medical Center, Duke Clinical Research Institute, NC, USA., Chiang CE; General Clinical Research Center, Division of Cardiology, Taipei Veterans General Hospital and National Yang-Ming Chiao Tung University, Taipei, Taiwan., Gibbs H; Department of General Medicine, Alfred Hospital, Melbourne, Australia., Tse E; Department of Medicine, Queen Mary Hospital, Hong Kong., Verhamme P; Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium., Ten Cate H; Department of Internal Medicine, Division of Vascular Medicine and Thrombosis Expertise Center, Maastricht University Medical Center (MUMC+), Maastricht, the Netherlands., Muntaner J; Model Centre for Cardiology, Faculty of Medicine, National University of Tucuman, Tucuman, Argentina., Schellong S; Medical Department 2, Municipal Hospital Dresden, Germany., Bounameaux H; Faculty of Medicine, Geneva, Switzerland., Prandoni P; Arianna Foundation on Anticoagulation, Bologna, Italy., Maheshwari U; Thrombosis Research Institute, London, United Kingdom., Kakkar AK; Thrombosis Research Institute, London, United Kingdom. |
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Jazyk: | angličtina |
Zdroj: | Thrombosis research [Thromb Res] 2023 Feb; Vol. 222, pp. 31-39. Date of Electronic Publication: 2022 Nov 25. |
DOI: | 10.1016/j.thromres.2022.11.016 |
Abstrakt: | 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. Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Alexander G. G. Turpie: Honoraria from Bayer Pharma AG, Janssen. Sylvia Haas: Honoraria from Bayer Pharma AG, Bristol Myers Squibb, Daiichi-Sankyo, Pfizer, Portola, Sanofi. Walter Ageno: Honoraria from Boehringer Ingelheim, Bayer Pharma AG, Bristol Myers Squibb, Pfizer, Daiichi-Sankyo, Portola, Aspen, Sanofi. Research support from Bayer Pharma AG. Jeffrey I. Weitz: Research support from Canadian Institutes of Health Research, Heart and Stroke Foundation, and the Canadian Fund for Innovation. Honoraria from Alnylam, Anthos, Bayer Pharma AG, Boehringer-Ingelheim, Bristol Myers Squibb, Daiichi-Sankyo, Ionis, Janssen, Merck, Novartis Pfizer, PhaseBio, and Servier. Samuel Z. Goldhaber: Research Support from Bayer Pharma AG, Boehringer-Ingelheim, BMS, BTG EKOS, Daiichi, Janssen, NHLBI, Thrombosis Research Institute. Consultancy fees from Bayer Pharma AG, Boehringer-Ingelheim. Shinya Goto: Research funding from Ono, Bristol Myers Squibb, Sanofi, and Pfizer. Personal fees from Thrombosis Research Institute and the American Heart Association. Renato D. Lopes: Research grants and personal fees from Bristol-Myers Squibb and Pfizer, personal fees from Boehringer Ingelheim and Bayer AG, research grants from Amgen Inc, GlaxoSmithKline, Medtronic PLC, and Sanofi Aventis. Chern-En Chiang: Honoraria from Astrazeneca, Boehringer Ingelheim, Daiichi-Sankyo, MSD, Novartis, Pfizer, and Sanofi. Harry Gibbs: Personal fees from Pfizer, Bayer, Boehringer Ingelheim. Peter Verhamme: Research support and honoraria from Bayer Healthcare, Boehringer, Daiichi-Sankyo, Anthos Pharmaceuticals, Portola, Leo-Pharma, BMS and Pfizer. Hugo ten Cate: research support from Bayer, consultant for Alveron. Shareholder Coagulation Profile. Second affiliation is Center of Thrombosis and Hemostasis (CTH), Gutenberg University Medical Center, Mainz, Germany. Juan Muntaner: Speaker fees from Bayer Pharma Latin America. Sebastian Schellong: Speaker fees from Bayer Pharma AG, Boehringer-Ingelheim, Bristol Meyer Squibb, Daiichi-Sankyo, Sanofi Aventis and Pfizer. Consultancy fees from Bayer Pharma AG, Boehringer-Ingelheim, Daiichi-Sankyo, Sanofi Aventis, Aspen and Pfizer. Paolo Prandoni: Personal fees from Bayer Pharma AG, Pfizer, Daiichi-Sankyo and Sanofi. Professor Ajay K Kakkar: Research grants from Bayer Pharma AG and Sanofi. Personal fees from Anthos Therapeutics, Bayer Pharma AG, Sanofi S.A, and Alfredo E. Farjat, Henri Bounameaux, Pantep Angchaisuksiri, Gloria Kayani, Eric Tse: None. (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.) |
Databáze: | MEDLINE |
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