CANVAS (direct oral anticoagulants)
Trial question
Is DOAC noninferior to LMWH in patients with cancer who had a new diagnosis of VTE?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
55.0% female
45.0% male
N = 638
638 patients (353 female, 285 male).
Inclusion criteria: patients with cancer who had a new clinical or radiological diagnosis of VTE.
Key exclusion criteria: acute leukemia; recent/planned stem cell transplant; ongoing clinically significant bleeding; pregnancy; life expectancy of < 3 months; use of medications that interfered with DOACs metabolism.
Interventions
N=330 DOACs (apixaban, rivaroxaban, dabigatran, or edoxaban).
N=308 LMWH (enoxaparin, dalteparin, or fondaparinux).
Primary outcome
Recurrent nonfatal venous thromboembolism at 6 months
6.1%
8.8%
8.8 %
6.6 %
4.4 %
2.2 %
0.0 %
Direct oral
anticoagulants
Low molecular weight
heparin
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in recurrent nonfatal VTE at 6 months (6.1% vs. 8.8%; ARD -2.7, 95% CI -6.8 to 1.4).
Secondary outcomes
No significant difference in death (21.5% vs. 18.4%; AD 3.1%, 95% CI -3.1 to 9.3).
No significant difference in restricted mean survival time (161 days vs. 164 days; AD -3 days, 95% CI -9 to 4).
No significant difference in major bleeding (5.2% vs. 5.6%; ARD -0.4, 95% CI -3.9 to 3.1).
Safety outcomes
No significant difference in any serious adverse events and severe serious adverse events.
Conclusion
In patients with cancer who had a new clinical or radiological diagnosis of VTE, DOACs were noninferior to LMWH with respect to recurrent nonfatal VTE at 6 months.
Reference
Deborah Schrag, Hajime Uno, Rachel Rosovsky et al. Direct Oral Anticoagulants vs Low-Molecular-Weight Heparin and Recurrent VTE in Patients With Cancer: A Randomized Clinical Trial. JAMA. 2023 Jun 13;329(22):1924-1933.
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