RCT | Noninferiority shown between DOACs and LMWH for recurrent VTE prevention in cancer patients

Summary: This unblinded, pragmatic, noninferiority randomized clinical trial aimed to assess the efficacy of direct oral anticoagulants (DOACs) against low-molecular-weight heparin (LMWH) in preventing recurrent venous thromboembolism (VTE) in patients with cancer. The study included 671 patients from 67 oncology centers, with a new clinical or radiological diagnosis of VTE.

Participants were randomly assigned to receive either a DOAC or LMWH for 6 months, and treating physicians selected and prescribed the drugs based on considerations like availability and drug-drug interactions. The primary outcome was the rate of recurrent VTE at 6 months. Findings revealed that the DOAC group had a recurrent VTE rate of 6.1% as compared to 8.8% in the LMWH group, showing noninferiority. Both groups had statistically similar rates of major bleeding and severe adverse events.

This pragmatic study included patients with advanced cancer and brain metastases, impaired performance status, and reduced liver or kidney function, making it more representative of routine oncology practice. Moreover, patient adherence to DOAC treatment was significantly higher than to LMWH. Nevertheless, the study had limitations, including the lack of blinding and underrepresentation of certain racial and ethnic groups.

In conclusion, this trial suggests that DOACs were noninferior to LMWH for preventing recurrent VTE in patients with cancer over a 6-month follow-up period, supporting the use of DOACs in this population for VTE prevention. Further research is needed to confirm these results and investigate long-term outcomes.

Article: Direct Oral Anticoagulants vs Low-Molecular-Weight Heparin and Recurrent VTE in Patients With Cancer: A Randomized Clinical Trial – JAMA (free for a limited period)

See also: Visual abstract

Commentary on Twitter

Among adults with cancer and VTE, direct oral anticoagulants were noninferior to low-molecular-weight heparin for preventing recurrent VTE over 6-month follow-up. #ASCO23 https://t.co/DP5RvlSYxe pic.twitter.com/rBJ99plopK

— JAMA (@JAMA_current) June 2, 2023