In the CANVAS study, reported in JAMA, Deb Schrag, MD, FASCO, MPH, and colleagues found that use of direct oral anticoagulants was noninferior to low–molecular-weight heparin in preventing recurrent venous thromboembolism (VTE) in patients with cancer.
Study Details
In the open-label trial, 671 patients with cancer (any invasive solid tumor, lymphoma, multiple myeloma, or chronic lymphocytic leukemia) who had a new clinical or radiologic diagnosis of VTE at 67 U.S. oncology practices were randomly assigned between December 2016 and April 2020 to receive a direct oral anticoagulant (n = 335) or low–molecular-weight heparin (n = 366) and followed for 6 months.
Deb Schrag, MD, FASCO, MPH
Physicians and patients selected any direct oral anticoagulant or any low–molecular-weight heparin; physicians selected drug doses. The primary outcome measure was recurrent VTE rate at 6 months; noninferiority of direct oral anticoagulants vs low–molecular-weight heparin was defined as an upper limit of the 1-sided 95% confidence interval of < 3% for the difference among patients receiving at least one dose of the study drug.
Key Findings
A total of 330 patients in the direct oral anticoagulant group and 308 in the low–molecular-weight heparin group received at least one dose of the study drug. Rates of recurrent VTE at 6 months were 6.1% in the direct oral anticoagulant group vs 8.8% in the low–molecular-weight heparin group (difference = −2.7%, 1-sided 95% confidence interval [CI] = −100% to 0.7%), satisfying the noninferiority criterion.
No significant differences were observed in other outcome measures. Major bleeding occurred in 5.2% of the direct oral anticoagulant group vs 5.6% of the low–molecular-weight heparin group (difference = −0.4%, 1-sided 95% CI = –100% to 2.5%). At 6 months, death occurred in 21.5% of patients in the direct oral anticoagulant group vs 18.4% of patients in the low–molecular-weight heparin group (difference = 3.1%, 1-sided 95% CI = −100% to 8.3%).
Adverse events, including VTE and bleeding, occurred in 36.0% of the direct oral anticoagulant group vs 38.7% of the low–molecular-weight heparin group (difference = −2.7%, 95% CI = −10.2% to 4.8%). Grade ≥ 3 anemia occurred in 3.0% vs 1.0% of patients.
The investigators concluded, “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. These findings support use of a direct oral anticoagulant to prevent recurrent VTE in patients with cancer.”
Dr. Schrag, of Memorial Sloan Kettering Cancer Center, is the corresponding author for the JAMA article.
Disclosure: The study was supported by a grant from the Patient-Centered Outcomes Research Institute (PCORI). For full disclosures of the study authors, visit jamanetwork.com.
