The use of direct oral anticoagulant (DOAC) therapy was found to be noninferior to low-molecular-weight heparin (LMWH) use in preventing recurrent venous thromboembolism (VTE) in a recent study of patients with cancer who have had a VTE event. The study’s findings were reported in JAMA.
“Among adults with cancer and VTE, DOACs were noninferior to LMWH for preventing recurrent VTE over 6-month follow-up,” the study investigators wrote in their report.
The CANVAS trial was an unblinded, comparative effectiveness, noninferiority study (ClinicalTrials.gov Identifier: NCT02744092) including patients with cancer who had had a VTE detected within 30 days prior to enrollment.
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Patients were randomly assigned 1:1 to treatment with either a DOAC or LMWH, with follow-up lasting for 6 months or until death. Patients were enrolled from December 2016 to April 2020 and had a final follow-up in November 2020. The 6-month cumulative incidence of recurrent, nonfatal VTE was the primary outcome in this study that evaluated the noninferiority of DOACs compared with LMWH for anticoagulation.
There were 638 patients who received at least 1 treatment dose and were included in the primary analysis, with 330 in the study arm receiving DOAC therapy and 308 in the arm receiving LMWH. Median ages in the study arms were 64 years and 62 years, respectively. Tumor types that were considered highly thrombogenic were present in 34% of patients of the DOAC arm and in 32% of the LMWH arm.
At 6 months, the cumulative incidence of recurrent VTE was 6.1% in the DOAC arm, and it was 8.8% in the LMWH arm, for a difference of -2.7% (1-sided 95% CI, -100% to 0.7%). Based on prespecified criteria, these results supported noninferiority, but not superiority, for DOACs in comparison with LMWH in this analysis.
Major bleeding was reported at 6 months in 5.2% of patients in the DOAC arm and in 5.6% of patients in the LMWH arm, although the difference in this outcome between treatment arms did not meet prespecified criterion for noninferiority. Deaths in the 6-month period were reported among 21.5% of patients in the DOAC arm and among 18.4% of patients in the LMWH arm.
Serious adverse events were reported in 36.0% of patients in the DOAC arm and in 38.7% of patients in the LMWH arm. Severe adverse events were reported in 33.8% and 35.1% of patients, respectively.
The study investigators concluded that 6 months of DOAC treatment showed noninferiority, compared with LMWH use, in prevention of VTE recurrence and that differences in rates of major bleeding and deaths between study arms were not statistically significant. They also indicated that the study’s results support using DOAC therapy for preventing recurrent VTE in patients with cancer.
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, or device companies. Please see the original reference for a full list of disclosures.
Reference
Schrag D, Uno H, Rosovsky R, et al; for the CANVAS Investigators. Direct oral anticoagulants vs low-molecular-weight heparin and recurrent VTE in patients with cancer: a randomized clinical trial. JAMA. 2023;329(22):1924-1933. doi:10.1001/jama.2023.7843
