Direct Oral Anticoagulants vs Low-Molecular-Weight Heparin and Recurrent Venous Thromboembolism (VTE) in Patients With Cancer: A Randomized Clinical Trial
Primary result · Recurrent VTEResult — go to the resultDifference −2.7% 1-sided 95% CI −100% to 0.7%Authors' conclusion
Among adults with cancer and VTE, DOACs were noninferior to LMWH for preventing recurrent VTE over 6-month follow-up.
Study context
- Population
- Patients with cancer (invasive solid tumor, lymphoma, multiple myeloma or CLL) with a new diagnosis of VTE638 (95%) completed
- Participants
- 671 patients
- Comparison
- Direct oral anticoagulant (DOAC) vs low-molecular-weight heparin (LMWH)
- DOACn = 335
- LMWHn = 336reference
- Primary endpoint
- Recurrent VTE rate
- Follow-up
- 6 months
Methodological detailsunblinded, comparative effectiveness, non-inferiority, 67 US oncology practices
- Unblinded
- Comparative effectiveness
- Non-inferiority
- 67 US oncology practices
Primary result
Recurrent VTE
Difference
−2.7%
1-sided 95% CI −100% to 0.7%
By group
DOACvs LMWH
difference −2.7% (1-sided 95% CI −100% to 0.7%)
Non-inferiority margin 3 as printed, not drawn
As reported in the abstract
Secondary outcomes
6 prespecified secondary outcomes
- None statistically significant
Safety
| Outcome | DOAC | LMWH | Difference (1-sided 95% CI) | |
|---|---|---|---|---|
| Major bleedingDid not meet noninferiority criterion (margin 2.5%) | 5.2% | 5.6% | −0.4% (−100% to 2.5%) | |
| −150−100−50050Difference (linear scale) |
Severe adverse events · Most common serious AEs: anemia and death
- Major bleeding: 1-sided 95% CI
- Major bleeding: non-inferiority margin 2.5%; not met
Original publication
Direct Oral Anticoagulants vs Low-Molecular-Weight Heparin and Recurrent VTE in Patients With Cancer: A Randomized Clinical Trial. JAMA. Published 13 June 2023. doi:10.
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