Abstract Number: PB2412
Meeting: ISTH 2020 Congress
Background: Phase 3 trials have shown comparable efﬁcacy of direct oral anticoagulants (DOACs) and vitamin K antagonists in patients with acute venous thromboembolism (VTE), with less major bleeding events in patients randomized to DOAC treatment. With DOACs being increasingly used in clinical practice, evaluation of the DOACs in daily practice-based conditions is needed to confirm their safety and effectiveness.
Aims: To evaluate the effectiveness and safety of apixaban in VTE patients in daily practice.
Methods: In this retrospective cohort study, consecutive patients diagnosed with venous thromboembolism in two Dutch hospitals (Leiden University Medical Center, Leiden and Haga Teaching Hospital, The Hague) were identified based on administrative codes. We assessed recurrent VTE, major bleeding and mortality during a 3-month follow-up period in those treated with apixaban.
Results: Of 671 consecutive VTE patients treated with apixaban from January 2016 until July 2018, 371 presented with acute pulmonary embolism (PE) and 300 patients with deep-vein thrombosis (DVT). The baseline demographic are summarized in Table 1. Their mean age was 59.7 years (SD 16.4), 48% was female and 6% had active malignancy at time of diagnosis. Two patients were diagnosed with recurrent VTE (0.3%; 95%CI 0.08-1.1, Table 2) and 12 with major bleeding (1.8%; 95%CI 1.0-3.2); 11 patients died (1.6%; 95%CI 0.9 – 2.9), of which one patient because of fatal PE and one because of a possible intracranial bleed. Other side effects of apixaban were mostly transient and included headache (2.5%), nausea (0.9%), hypersensitivity/rash (0.4%) and abdominal discomfort (2.4%), causing switch to an alternative anticoagulant in 13% of all patients with side effects.
Conclusions: In this large practice based cohort with patient level data, treatment of apixaban yielded a low incidence of recurrent VTE, comparable to the phase 3 Amplify study patients, but a higher incidence of major bleeding, reflecting the importance of daily practice evaluation.
|Age, mean (SD)||59.7||16.4|
|Male sex, no (%)||347||51.7|
|Weight in kg, mean (SD)||84.7||18.6|
|VTE risk factors|
|Previous venous thromboembolism no. (%)||145||22|
|COPD no. (%)||65||9.7|
|Estrogen use no. (%)||67||10|
|Immobilisation no. (%)||174||26|
|Active malignancy no. no. (%)||42||6.3|
[Table 1: Baseline characteristics of patients with VTE treated with apixaban]
|1. Overall mortality||11||1.6||0.9 – 2.9|
|2. Major bleeding||12||1.8||1.0 – 3.2|
|3. Recurrent VTE||2||0.3||0.08 – 1.1|
[Table 2: VTE-related adverse events of patients treated with apixaban]
To cite this abstract in AMA style:Hendriks SV, Klok FA, Stenger WJE, Mairuhu ATA, Eikenboom J, Fogteloo J, Huisman MV. Effectiveness and Safety of Apixaban for Treatment of Venous Thromboembolism in a Large Daily Practice Cohort [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/effectiveness-and-safety-of-apixaban-for-treatment-of-venous-thromboembolism-in-a-large-daily-practice-cohort/. Accessed September 27, 2023.
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