New Oral Anticoagulants for the Treatment of Venous Thromboembolism: Understanding Differences and Similarities

Abstract

Venous thromboembolism (VTE) is a major cause of morbidity, mortality, and healthcare expenditure. In the United States, approximately 0.1 % of the population experiences an initial VTE event each year. Anticoagulation therapy is the cornerstone of acute VTE treatment and for prevention of recurrent VTE events. Conventional anticoagulants, including heparin, low-molecular-weight heparins, fondaparinux, and vitamin K antagonists are widely used but have limitations. Newer oral anticoagulant agents, including direct thrombin inhibitors (e.g., dabigatran etexilate) and direct factor Xa inhibitors (e.g., rivaroxaban, apixaban, and edoxaban) have been developed to attempt to overcome some of the limitations of conventional anticoagulant therapy. These new oral agents have been evaluated for safety and efficacy in large, randomized clinical trials in the treatment and secondary prevention of VTE with results that are comparable to conventional therapy. Dabigatran, rivaroxaban, apixaban, and edoxaban are important new treatment options for patients with VTE. In this review, we compare these new agents and their associated clinical trials in VTE treatment.

Possible failure of novel direct-acting oral anticoagulants in management of pulmonary embolism: a case report

“…Alternatively, novel direct-acting oral anticoagulants aim to provide a safer, more tolerable, treatment option as compared to warfarin to prevent and treat DVT, PE, and atrial fibrillation (Afib) [3, 6]. Benefits of novel direct-acting oral anticoagulants include: (a) no need to monitor INR levels, and (b) potentially decreased drug interactions and adverse events (such as bleeding episodes).…”

Overview of Current Evidence on the Impact of the Initial High Dose of the Direct Factor Xa Inhibitor Rivaroxaban on Thrombus Resolution in the Treatment of Venous Thromboembolism

“…16) It is important to note that the extent of initial thrombus burden was highly variable in the NOAC phase III trials, with 69% of rivaroxaban-treated patients in EINSTEIN DVT, 43% of apixaban-treated patients in AMPLIFY, and 42% of edoxaban-treated patients in Hokusai-VTE exhibiting extensive DVT. 14,22,24,39) As with the EINSTEIN DVT results for rivaroxaban, AMPLIFY demonstrated no connection between the extent of initial thrombus burden and efficacy of treatment with apixaban, whereas the Hokusai-VTE and RE-COVER trials did not report the full set of corresponding data for edoxaban and dabigatran, respectively, to investigate this relationship. [22][23][24] Japanese patients were not enrolled into the global rivaroxaban studies because of a trend to anticoagulate patients at a lower intensity; therefore, a separate study was performed in Japan.…”

The Anticoagulation Treatment of Venous Thromboembolism: from Randomized Clinical Studies to the Data from the Real Clinical Practice

“…и в России (август 2013 г.). Эффективность и без опасность ривароксабана для лечения ТГВ и ТЭЛА были доказаны в исследованиях III фазы EINSTEIN DVT (лечение ТГВ) и EINSTEIN PE (лечение ТЭЛА) [21,22]. Это открытые рандомизированные исследования, в которых сравнивали применение ривароксабана (15 мг 2 раза в день на протяжении 3 нед, с переходом на 20 мг 1 раз в сутки с 22го дня лечения) со стандартной схемой антикоагулянтной терапии (эноксапарин 1мг/кг 2 раза в сутки на про тяжении минимум 5 дней, с переходом на АВК при достижении целевого МНО от 2 до 3) у пациентов с подтвержденным ТГВ и/или ТЭЛА.…”

“…Так, критери ями исключения из EINSTEIN DVT были тяжелая почечная недостаточность (клиренс креатинина ме нее или равно 30 мл/мин), высокий риск геморраги ческих осложнений, наличие беременности, прове дение тромболитической терапии либо тромбэкто мии и т.д. [22].…”

“…Это позволяет говорить об экономи ческой пользе в связи с упрощенным ведением паци ентов как в стационаре, так и в амбулаторных услови ях, без необходимости подкожных инъекций прямых антикоагулянтов и мониторинга состояния коагуля ции. Результаты наблюдательного исследования XA LIA полностью согласуются с данными рандомизи рованного исследования EINSTEIN DVT [21][22][23][24][25].…”