6/28/23, 12:43 AM APEX Pathway Feedback Search Clinical Topics Home Studies APEX APEX Disease Disease Deep vein thrombosis Pulmonary embolism Trial question What is the role of extended thromboprophylaxis with betrixaban in patients with acute medical illness? Study design Multi-center Double blinded RCT Population Characteristics of study participants 54.0% female N = 7513 46.0% male 7513 patients (4088 female, 3425 male) Inclusion criteria: patients who were hospitalized for acute medical illnesses Key exclusion criteria: unable to receive nourishment by enteral administration, anticipated need for prolonged anticoagulation during the trial, life expectancy < 8 weeks, at risk of increased bleeding, or contraindication to anticoagulation therapy Interventions N=3759 betrixaban (80 mg once daily for 35 to 42 days, plus subcutaneous enoxaparin placebo for 10 +/- 4 days) N=3754 enoxaparin (40 mg once daily SC for 10 +/- 4 days, plus oral betrixaban placebo for 35 to 42 days) https://web.pathway.md/studies/recwBIJivmAM1P9Hx 1/2 6/28/23, 12:43 AM APEX Pathway Primary outcome Asymptomatic proximal deep vein thrombosis and symptomatic venous thromboembolism in patients with an elevated D-dimer level 8.5 % 8.5 6.9 6.4 % 4.3 % 2.1 % Borderline significant decrease 0.0 % Betrixaban Enoxaparin Borderline significant decrease in asymptomatic proximal deep vein thrombosis and symptomatic VTE in patients with an elevated D-dimer level (6.9% vs. 8.5%; RR 0.81, 95% CI 0.65 to 1) Secondary outcomes Significant decrease in the rate of asymptomatic proximal deep vein thrombosis or symptomatic VTE, in patients with an elevated D-dimer level or an age 75 years (5.6% vs. 7.1%; RR 0.8, 95% CI 0.66 to 0.98) Safety outcomes No significant differences in major bleeding (0.7% vs. 0.6%,p=0.55; RR 1.19, 95% CI, 0.67 to 2.12). Conclusion In patients who were hospitalized for acute medical illnesses, betrixaban was superior to enoxaparin with respect to asymptomatic proximal deep vein thrombosis and symptomatic VTE in patients with an elevated D-dimer level. Reference Cohen AT, Harrington RA, Goldhaber SZ et al. Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients. N Engl J Med. 2016 Aug 11;375(6):534-44. Open reference URL https://web.pathway.md/studies/recwBIJivmAM1P9Hx 2/2