Early Time Courses of Recurrent Venous Thromboembolism and Bleeding during Apixaban or Dalteparin Therapy for Patients with Cancer
Key result
Apixaban proves noninferior to dalteparin for preventing recurrent cancer-associated VTE.
- HR 0.63
- 95% CI 0.37-1.07
- P<0.001 for noninferiority
- n=1,155
Why the study?
Recurrent VTE and major bleeding rates peak during the first weeks of anticoagulation, but the early time course comparing apixaban and dalteparin in cancer-associated VTE had not been evaluated.
Does apixaban reduce recurrent VTE and major bleeding compared to dalteparin at 7, 30, and 90 days in patients with cancer-associated VTE?
Population
1,155 patients with cancer-associated VTE
Comparison
Apixaban monotherapy vs dalteparin monotherapy
Design
Randomized controlled trial (CARAVAGGIO trial analysis)
Follow-up
6 months (assessed at 7, 30, and 90 days)
Authors
Discussion
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Member takes
Implication
Supports oral apixaban initiation in cancer-associated VTE; extends DOAC evidence versus LMWH to early treatment windows.
Study Design
Type
RCT (n=1,155)
Blinding
Open-label
Randomization
Randomly assigned
Multicenter
Yes
Structured PICO
Does apixaban reduce recurrent VTE and major bleeding compared to dalteparin at 7, 30, and 90 days in patients with cancer-associated VTE?
P
Population
1,155 patients aged 18 years or older with newly diagnosed symptomatic or incidental proximal lower limb DVT or PE and confirmed cancer, followed for 6 months.
I
Intervention
Apixaban 10 mg oral twice daily for 7 days, followed by 5 mg twice daily for 6 months
C
Comparator
Dalteparin 200 IU/kg subcutaneous once daily for the first month, then 150 IU/kg daily (maximum 18,000 IU) for 6 months
O
Outcome
Incidence of objectively confirmed recurrent VTE (proximal DVT of the lower limbs, symptomatic DVT of the upper limbs, and PE) occurring during the 6-month trial period, analyzed at 7, 30, and 90 dayshard clinical
Main Result
Hazard Ratio: 0.63 (95% CI 0.37–1.07)
Absolute Event Rate: 5.6% vs 7.9%
p-value: p=<0.001 for noninferiority
Apixaban is comparable to dalteparin for the early treatment of cancer-associated VTE, with similar rates of recurrence and major bleeding at 7, 30, and 90 days, supporting early initiation of oral anticoagulation.
Limitations
- Open-label trial design
- Exclusion of patients with brain tumors, known cerebral metastases, or acute leukemia
- Results of the time point analysis were not adjusted for the study center
- Small patient numbers in sub-cohorts resulted in measures of effect with wide confidence intervals
- Exclusion of patients with brain tumors, known cerebral metastases, or acute leukemia limits extrapolation to these groups
- Results of this time point analysis have not been adjusted for the study center
- Small patient numbers result in measures of effect with wide CIs for subgroups
Cite This Study
Cohen et al. (2024) conducted an RCT in Cancer-associated venous thromboembolism (VTE) (n=1,155). Apixaban vs. Dalteparin (200 IU/kg once daily for 1 month, then 150 IU/kg daily) was evaluated on Incidence of objectively confirmed recurrent VTE at 6 months (HR 0.63, 95% CI 0.37-1.07, p=<0.001 for noninferiority). Apixaban was noninferior to dalteparin for the treatment of cancer-associated VTE, with recurrent VTE occurring in 5.6% of apixaban patients versus 7.9% of dalteparin patients at 6 months (HR 0.63, p<0.001 for noninferiority).