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.
Highlights
Subgroup analyses from randomized clinical trials suggested that the direct oral anticoagulants (DOACs) may have some advantages over standard therapy in fragile patients with venous thromboembolism (VTE)
We found that 42% of VTE patients in real life are fragile,[3] and that during anticoagulation they had fewer VTE recurrences and more major bleeding events than the nonfragile
Patients receiving DOACs were 2 years younger than those treated with low-molecular-weight heparin (LMWH), less likely presented with pulmonary embolism (PE), and were less likely to have cancer, anemia, or renal insufficiency, but were more likely to have unprovoked VTE, prior VTE, chronic heart failure, or to receive corticosteroids at baseline (►Table 1)
Summary
Subgroup analyses from randomized clinical trials suggested that the direct oral anticoagulants (DOACs) may have some advantages over standard therapy in fragile patients with venous thromboembolism (VTE). In the EINSTEIN trials, the rate of major bleeding was much lower in fragile patients receiving rivaroxaban than in those on standard therapy.[1] This difference was not seen in nonfragile patients. The HOKUSAI trial found a higher efficacy using edoxaban than warfarin in fragile patients, without any safety concern.[2] Fragile patients are underrepresented in clinical trials, and these favorable results have not been validated yet in real life. We found that 42% of VTE patients in real life are fragile,[3] and that during anticoagulation they had fewer VTE recurrences and more major bleeding events than the nonfragile. The efficacy and safety of the direct oral anticoagulants (DOACs) in fragile patients 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
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