Real‐life Use of Anticoagulants in Venous Thromboembolism With a Focus on Patients With Exclusion Criteria for Direct Oral Anticoagulants

Abstract

and the RIETE InvestigatorsWe assessed the real-life use of direct oral anticoagulants (DOACs) in patients with venous thromboembolism (VTE) and exclusion criteria for randomized trials. From 2013 to 2016, 3,578 of 18,853 patients (19%) had exclusion criteria. Irrespective of which anticoagulant was chosen, they had more VTE recurrences (hazard ratio (HR): 3.10; 95% confidence interval (CI): 2.47-3.88), major bleeds (HR: 4.10; 95% CI: 3.38-4.96), and deaths (HR: 9.47; 95% CI: 8.46-10.6) than those without exclusion criteria. During initial therapy, no patient with exclusion criteria on DOACs (n 5 115) recurred, but those on rivaroxaban bled less often (adjusted HR: 0.18; 95% CI: 0.04-0.79) than those on unfractionated heparin (n 5 224) and similar to those (n 5 3,172) on low-molecular-weight (LMWH) heparin. For long-term therapy, patients on rivaroxaban (n 5 151) had nonsignificantly fewer VTE recurrences (adjusted HR: 0.74; 95% CI: 0.08-1.32) and major bleeds (adjusted HR: 0.41; 95% CI: 0.15-1.15) than those on LMWH (n 5 2,071). The efficacy and safety of DOACs were similar to standard therapy.

Safety and Effectiveness of Edoxaban in Japanese Patients With Venous Thromboembolism ― An Interim Analysis of Data From a Japanese Postmarketing Observational Study (ETNA-VTE-Japan) ―

“…In the RIETE registry, patients receiving under-doses of DOACs experienced a higher rate of VTE recurrence, and similar results were shown in some studies of patients with AF. 21,29,30 In the present study, the incidence of VTE recurrence was not increased in underdosed patients. However, it is not possible to draw a firm conclusion from the results at 3 months, so further monitoring of the outcomes in these patients will be necessary.…”

“…The incidence of under-dosing of DOACs was investigated in the RIETE registry, which enrolled patients with VTE receiving DOACs. 21 In that study, 17% of patients receiving rivaroxaban and 50% of patients receiving apixaban were under-dosed. However, in the present study, the proportion of patients who received an under-dose of edoxaban was low (7.4%).…”

Different Types of Statins and All-Cause Mortality during Anticoagulation for Venous Thromboembolism: Validation Study from RIETE Registry

“…Data from this registry have been used to evaluate outcomes after acute VTE such as the frequency of recurrent VTE, major bleeding or mortality, and risk factors for these outcomes. [13][14][15][16][17][18] The rationale and methodology of RIETE have been published elsewhere. 19 In the current analysis, we aimed to validate our prior observations in a subsequent cohort of patients with VTE and to compare the mortality risk according to the type of statins.…”

Safety of Low Dose of Edoxaban to Treat Acute and Long Term Treatment of a VTE Occurred in a Very Young Adolescent

“…Although DOACs are the suggested drugs to treat VTE, there is not info on pre-marketing studies or guidelines that testify the efficacy and safety of these drugs in patients aged less than 18 years. On the other hand, juvenile patients may show usually such of any condition that are reported as critical for the use of DOACs as low BMI [10]. Furthermore, pharmacokinetic of edoxaban could be different in adolescent because different bowel absorption and kidney clearance [11].…”