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On-treatment Comparative Effectiveness of Vitamin K Antagonists and Direct Oral Anticoagulants in GARFIELD-VTE, and Focus on Cancer and Renal Disease
S. Haas, AE. Farjat, K. Pieper, W. Ageno, P. Angchaisuksiri, H. Bounameaux, SZ. Goldhaber, S. Goto, L. Mantovani, P. Prandoni, S. Schellong, AGG. Turpie, JI. Weitz, P. MacCallum, HT. Cate, E. Panchenko, M. Carrier, C. Jerjes-Sanchez, H. Gibbs, P....
Status neindexováno Jazyk angličtina Země Německo
Typ dokumentu časopisecké články
NLK
Directory of Open Access Journals
od 2017
PubMed Central
od 2017
Europe PubMed Central
od 2017
ROAD: Directory of Open Access Scholarly Resources
od 2017
Thieme Connect Journals Open Access
od 2017
PubMed
36452204
DOI
10.1055/s-0042-1757744
Knihovny.cz E-zdroje
- Publikační typ
- časopisecké články MeSH
Background Direct oral anticoagulants (DOACs) provide a safe, effective alternative to vitamin K antagonists (VKAs) for venous thromboembolism (VTE) treatment, as shown via intention-to-treat comparative effectiveness analysis. However, on-treatment analysis is imperative in observational studies because anticoagulation choice and duration are at investigators' discretion. Objectives The aim of the study is to compare the effectiveness of DOACs and VKAs on 12-month outcomes in VTE patients using on-treatment analysis. Methods The Global Anticoagulant Registry in the FIELD - VTE (GARFIELD-VTE) is a world-wide, prospective, non-interventional study observing treatment of VTE in routine clinical practice. Results In total, 8,034 patients received VKAs ( n = 3,043, 37.9%) or DOACs ( n = 4,991, 62.1%). After adjustment for baseline characteristics and follow-up bleeding events, and accounting for possible time-varying confounding, all-cause mortality was significantly lower with DOACs than VKAs (hazard ratio: 0.58 [95% confidence interval 0.42-0.79]). Furthermore, patients receiving VKAs were more likely to die of VTE complications (4.9 vs. 2.2%) or bleeding (4.9 vs. 0.0%). There was no significant difference in rates of recurrent VTE (hazard ratio: 0.74 [0.55-1.01]), major bleeding (hazard ratio: 0.76 [0.47-1.24]), or overall bleeding (hazard ratio: 0.87 [0.72-1.05]) with DOACs or VKAs. Unadjusted analyses suggested that VKA patients with active cancer or renal insufficiency were more likely to die than patients treated with DOAC (52.51 [37.33-73.86] vs. 26.52 [19.37-36.29] and 9.97 [7.51-13.23] vs. 4.70 [3.25-6.81] per 100 person-years, respectively). Conclusion DOACs and VKAs had similar rates of recurrent VTE and major bleeding. However, DOACs were associated with reduced all-cause mortality and a lower likelihood of death from VTE or bleeding compared with VKAs.
Arianna Foundation on Anticoagulation Bologna Italy
Center for Public Health Research University of Milan Bicocca Monza Italy
Department of Health Sciences Medical Department 2 Municipal Hospital Dresden Germany
Department of Medicine and Surgery University of Insubria Varese Italy
Department of Medicine Ramathibodi Hospital Mahidol University Thailand
Department of Medicine The Ottawa Hospital Ottawa Canada
Department of Medicine Tokai University School of Medicine Japan
Department of Medicine University of Geneva Switzerland
Formerly Technical University of Munich Munich Germany
Formerly Thrombosis Research Institute London United Kingdom
Instituto de Cardiología y Medicina Vascular TecSalud Sa Pedro Garza Garcia Mexico
McMaster University Hamilton Canada
Motol University Hospital Department of Cardiovascular Surgery Prague Czech Republic
Queen Mary University of London London United Kingdom
Tecnológico de Monterrey Escuela de Medicina y Ciencias de la Salud Monterrey Mexico
Citace poskytuje Crossref.org
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- $a Background Direct oral anticoagulants (DOACs) provide a safe, effective alternative to vitamin K antagonists (VKAs) for venous thromboembolism (VTE) treatment, as shown via intention-to-treat comparative effectiveness analysis. However, on-treatment analysis is imperative in observational studies because anticoagulation choice and duration are at investigators' discretion. Objectives The aim of the study is to compare the effectiveness of DOACs and VKAs on 12-month outcomes in VTE patients using on-treatment analysis. Methods The Global Anticoagulant Registry in the FIELD - VTE (GARFIELD-VTE) is a world-wide, prospective, non-interventional study observing treatment of VTE in routine clinical practice. Results In total, 8,034 patients received VKAs ( n = 3,043, 37.9%) or DOACs ( n = 4,991, 62.1%). After adjustment for baseline characteristics and follow-up bleeding events, and accounting for possible time-varying confounding, all-cause mortality was significantly lower with DOACs than VKAs (hazard ratio: 0.58 [95% confidence interval 0.42-0.79]). Furthermore, patients receiving VKAs were more likely to die of VTE complications (4.9 vs. 2.2%) or bleeding (4.9 vs. 0.0%). There was no significant difference in rates of recurrent VTE (hazard ratio: 0.74 [0.55-1.01]), major bleeding (hazard ratio: 0.76 [0.47-1.24]), or overall bleeding (hazard ratio: 0.87 [0.72-1.05]) with DOACs or VKAs. Unadjusted analyses suggested that VKA patients with active cancer or renal insufficiency were more likely to die than patients treated with DOAC (52.51 [37.33-73.86] vs. 26.52 [19.37-36.29] and 9.97 [7.51-13.23] vs. 4.70 [3.25-6.81] per 100 person-years, respectively). Conclusion DOACs and VKAs had similar rates of recurrent VTE and major bleeding. However, DOACs were associated with reduced all-cause mortality and a lower likelihood of death from VTE or bleeding compared with VKAs.
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