DOACs better than heparin for preventing recurrent VTE in cancer patients

A new study by Deborah Schrag and team it was shown that direct oral anticoagulants (DOAC) were noninferior to low-molecular-weight heparin (LMWH) for preventing recurrent venous thromboembolism (VTE) over a 6-month follow-up in people with cancer and VTE. The Findings of this study were published in the Journal of the American Medical Association.

Long-term anticoagulation with low-molecular-weight heparin is advised in cancer patients who experience venous thromboembolism episodes in order to avoid recurrence VTE. When compared to LMWH, a direct oral anticoagulant may be less effective at preventing recurrent VTE in cancer patients. In order to compare DOACs to LMWH for avoiding recurrent VTE and for rates of bleeding in patients with cancer following an initial VTE episode, this research was done.

67 oncology practices in the US participated in this unblinded, comparative efficacy, non-inferiority randomized clinical study, which included 671 cancer patients with new clinical or radiological diagnosis of VTE. From December 2016 to April 2020, enrollment took place. The last check-in took place in November 2020. A DOAC (n = 335) or LMWH (n = 336) was given to participants in a 1:1 ratio, and they were then monitored for six months or until they died. Any DOAC or any LMWH (or fondaparinux) was chosen by doctors and patients, and dosages were chosen by doctors.

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