Direct Oral Anticoagulants or Standard Anticoagulant Therapy in Fragile Patients with Venous Thromboembolism
Juan J López-Núñez1, Ricard Pérez-Andrés2, Pierpaolo Di Micco3
1Department of Internal Medicine, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, Spain.
Insights
Direct oral anticoagulants (DOACs) show promise for fragile patients with venous thromboembolism (VTE). This study found DOACs may be more effective and safer than standard treatments in this high-risk group.
Area of Science:
- Cardiology
- Hematology
- Pharmacology
Background:
- Limited data exists on direct oral anticoagulants (DOACs) for fragile patients with venous thromboembolism (VTE).
- Fragile patients are defined as those aged ≥ 75 years, with creatinine clearance ≤ 50 mL/min, and/or body weight ≤ 50kg.
- This patient subgroup faces a particularly high risk of bleeding complications.
Purpose of the Study:
- To evaluate the efficacy and safety of DOACs compared to standard anticoagulant therapies in fragile VTE patients.
- To assess the rates of VTE recurrence and major bleeding in this population.
Main Methods:
- Utilized the RIETE database, analyzing data from January 2013 to April 2018.
- Compared outcomes between fragile VTE patients receiving DOACs versus standard anticoagulants (low-molecular-weight heparin or vitamin K antagonists).
- Employed multivariable analysis to adjust for potential confounding factors.
Main Results:
- Out of 10,054 fragile patients, 4.7% initially received DOACs and 13% for long-term therapy.
- Patients initially on DOACs showed a lower rate of VTE recurrence or major bleeding compared to those on low-molecular-weight heparin (HR: 0.32).
- Long-term DOAC use was associated with a significantly lower risk of the composite outcome compared to vitamin K antagonists (HR: 0.61).
Conclusions:
- DOACs appear to be a potentially more effective and safer option than standard therapies for fragile VTE patients.
- The findings are particularly relevant given the heightened bleeding risk in this vulnerable patient group.
- Further research may confirm DOACs as a preferred treatment in elderly or frail VTE patients.
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.
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