APEX
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
46.0% male
N = 7513
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)
Primary outcome
Asymptomatic proximal deep vein thrombosis and symptomatic venous thromboembolism in patients with an elevated D-dimer level
6.9
8.5
8.5 %
6.4 %
4.3 %
2.1 %
0.0 %
Betrixaban
Enoxaparin
Borderline significant decrease ▼
Borderline significant decrease in asymptomatic proximal DVT 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 DVT 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 DVT 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.
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