DOACs better than heparin for preventing recurrent VTE in cancer patients

The recurrent VTE rate at 6 months was the main result. The upper limit of the 1-sided 95% CI for the difference between a DOAC and LMWH of less than 3% in the randomized group that received at least 1 dose of the assigned therapy served as the criterion for determining whether anticoagulation with a DOAC was superior than anticoagulation with LMWH. Major bleeding was one of the six predetermined secondary outcomes that was evaluated using a 2.5% noninferiority margin.

The key findings of this study were:

671 individuals were randomly assigned between December 2016 and April 2020, and 638 (or 95%) of them finished the experiment.

330 people who were randomly assigned to a DOAC got at least one dosage. 308 of the LMWH-randomized participants got at least one dosage.

Recurrent VTE rates were 6.1% in the DOAC group and 8.8% in the LMWH group, both of which were in accordance with the predetermined noninferiority criterion.

None of the six secondary outcomes that were predetermined were statistically significant. 5.2% of participants in the DOAC group and 5.6% of participants in the LMWH group experienced major bleeding, which did not satisfy the noninferiority requirement. 33.8% of individuals in the DOAC group and 35.1% of participants in the LMWH group experienced severe adverse events.

Anemia and fatalities were the most frequent severe adverse effects.

In conclusion, these results back up the use of a DOAC to stop recurrent VTE in cancer patients.

Reference: 

Schrag, D., Uno, H., Rosovsky, R., Rutherford, C., Sanfilippo, K., Villano, J. L., Drescher, M., Jayaram, N., Holmes, C., Feldman, L., Zattra, O., Farrar-Muir, H., Cronin, C., Basch, E., Weiss, A., Connors, J. M., Sumida, K. N. M., Martin, R. C., … Grosse Perdekamp, M. T. (2023). Direct Oral Anticoagulants vs Low-Molecular-Weight Heparin and Recurrent VTE in Patients With Cancer. In JAMA. American Medical Association (AMA). https://doi.org/10.1001/jama.2023.7843