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Open Access
CC BY 4.0 · TH Open 2019; 03(01): e67-e76
DOI: 10.1055/s-0039-1683970
Original Article
Georg Thieme Verlag KG Stuttgart · New York

Direct Oral Anticoagulants or Standard Anticoagulant Therapy in Fragile Patients with Venous Thromboembolism

Juan J. López-Núñez
1   Department of Internal Medicine, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Spain
,
Ricard Pérez-Andrés
2   Department of Radiology, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Spain
,
Pierpaolo Di Micco
3   Department of Internal Medicine and Emergency Room, Ospedale Buon Consiglio Fatebenefratelli, Naples, Italy
,
Sebastian Schellong
4   Department of Medical Clinic, Municipal Hospital of Dresden Friedrichstadt, Dresden, Germany
,
Covadonga Gómez-Cuervo
5   Department of Internal Medicine, Hospital Universitario 12 de Octubre, Madrid, Spain
,
Joan Carles Sahuquillo
6   Department of Internal Medicine, Hospital Municipal de Badalona, Barcelona, Spain
,
Maurizio Ciammaichella
7   Department of Emergency Internal Medicine, Ospedale St. John, Rome, Italy
,
Maria del Valle Morales
8   Department of Internal Medicine, Hospital del Tajo, Madrid, Spain
,
Marijan Bosevski
9   University Cardiology Clinic, Faculty of Medicine, Skopje, Republic of Macedonia
,
Manuel Monreal
1   Department of Internal Medicine, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Spain
,
and the RIETE Investigators› Author Affiliations
Further Information

Publication History

08 December 2018

06 February 2019

Publication Date:
20 March 2019 (online)

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Abstract

Background The efficacy and safety of the direct oral anticoagulants (DOACs) in fragile patients (age ≥ 75 years and/or creatinine clearance levels ≤ 50 mL/min and/or body weight ≤ 50kg) with venous thromboembolism (VTE) has not been evaluated.

Methods We used the RIETE database to compare the rates of the composite of VTE recurrences or major bleeding during anticoagulation in fragile patients with VTE, according to the use of DOACs or standard anticoagulant therapy.

Results From January 2013 to April 2018, 24,701 patients were recruited. Of these, 10,054 (41%) were fragile. Initially, 473 fragile patients (4.7%) received DOACs and 8,577 (85%) low-molecular-weight heparin (LMWH). For long-term therapy, 1,298 patients (13%) received DOACs and 5,038 (50%) vitamin K antagonists (VKAs). Overall, 95 patients developed VTE recurrences and 262 had major bleeding. Patients initially receiving DOACs had a lower rate of the composite outcome (hazard ratio [HR]: 0.32; 95% confidence interval [CI]: 0.08–0.88) than those on LMWH. Patients receiving DOACs for long-term therapy had a nonsignificantly lower rate of the composite outcome (HR: 0.70; 95% CI: 0.46–1.03) than those on VKAs. On multivariable analysis, patients initially receiving DOACs had a nonsignificantly lower risk for the composite outcome (HR: 0.36; 95% CI: 0.11–1.15) than those on LMWH, while those receiving DOACs for long-term therapy had a significantly lower risk (HR: 0.61; 95% CI: 0.41–0.92) than those on VKAs.

Conclusions Our data suggest that the use of DOACs may be more effective and safe than standard therapy in fragile patients with VTE, a subgroup of patients where the risk for bleeding is particularly high.

Keywords

venous thromboembolism - fragile patients - direct oral anticoagulants

Authors' Contributions

All the authors introduced patients in the database, performed the research, analyzed results, and reviewed the article. J. J. López-Núñez and M. Monreal designed the research and wrote the article.


* A full list of RIETE investigators is given in Appendix A.