ACC 2025: Lower-Dose Apixaban Is Effective, Safer Than Full Dose for Preventing VTE Recurrence in Patients With Cancer

Patients with active cancer who developed a blood clot or venous thromboembolism (VTE) and who were treated with blood-thinning medication for at least 6 months followed by an additional 12 months of low-dose apixaban (Eliquis; Bristol Myers Squibb, Pfizer) experienced similar recurrences of VTE and less bleeding compared to those who received a full dose of apixaban over the same extended period. The findings were presented at the American College of Cardiology (ACC) 2025 Scientific Session in Chicago, Illinois, from March 28 through March 31.¹

Cancer-associated thrombosis is a leading cause of morbidity and mortality | Image credit: Marharyta Tsapenko | stock.adobe.com

Cancer-associated thrombosis is a leading cause of morbidity and mortality among patients with cancer. Data have shown an increased risk of VTE in patients with malignancy, with prevalence as high as 20%. In one case-control study in the Netherlands, researchers found the overall risk of VTE to be 7-fold higher in patients with malignancy, with the highest risk in the first few months after diagnosis.²

According to researchers, cancer cells release substances that make it easier for blood clots to form. Additionally, cancer treatments themselves can also cause inflammation in blood vessels and elevate risk for blood clots. Surgery often limits patients’ mobility and invasive devices can further exacerbate the risk of VTE in this patient population.³

International guidelines recommend treatment with anticoagulants for at least 6 months and for as long as the cancer remains active, or cancer treatment continues. Data has shown that, although the risk of a recurrent VTE diminishes somewhat after 6 months of anticoagulant treatment, patients remain at considerable risk. However, studies have also shown that anticoagulant treatment may increase the risk of bleeding.³

“The best way to prevent a VTE recurrence after 6 months of anticoagulant treatment has not been clear,” said Isabelle Mahé, PhD, a professor of internal medicine at the Université Paris Cité, head of internal medicine at Public Assistance Hospitals of Paris, and principal investigator of the API-CAT study presented at ACC.³

The API-CAT trial was designed to assess whether the lower dose of apixaban was comparable to the full dose in preventing VTE recurrence among patients with active cancer who had completed at least 6 months of treatment with an anticoagulant medication for a VTE. Investigators also assessed whether the low dose resulted in a decreased risk of bleeding compared with a full dose.^1,3

A total of 1766 patients were prospectively enrolled in the randomized, international, double-blinded study, across 11 countries. Participants had an average age of 67 years and 57% were women. All had active cancer (breast cancer 22.7%; colorectal cancer, 15.3%; prostate cancer, 9.3%; other cancers, 41.4%), 65.8% had metastatic cancer, and 81.2% were receiving concurrent cancer treatment at the time of inclusion. The median time since VTE was 8 months, and all patients had completed 6 months of anticoagulant treatment at enrollment.^1,3

Participants were randomly assigned to either 5 mg (2.5 mg twice daily; the reduced-dose group) or 10 mg (5 mg twice daily; the full-dose group) of apixaban for an additional 12 months. At 12 months, 18 patients in the reduced-dose group and 24 in the full-dose group had had a recurrent VTE (12-month cumulative incidence of 2.1% and 2.8%, respectively), demonstrating a difference that was statistically significant for the non-inferiority of the reduced dose compared with the full dose. Clinically relevant bleeding requiring medical care occurred in 102 patients in the reduced-dose group compared with 136 in the full-dose group (12-month cumulative incidence of 12.1% and 15.6%, respectively), a statistically significant reduction in favor of the reduced dose. Death rates were similar in the 2 groups (17.7% in the reduced-dose group, 19.6% in the full-dose group).^1,3

“We can say that the lower-dose apixaban is both effective and safer than the full dose,” Mahé said, noting that the results should lead to a guideline update recommending extended treatment with a reduced-dose anticoagulant in this patient population.³

REFERENCES

1. Mahé I. Low-dose apixaban comparable to full dose for preventing VTE recurrence in patients with cancer. Presented at: American College of Cardiology 2025 Scientific Session. Chicago, IL; March 29-31, 2025.

2. Zaanona MIA, Mantha S. Cancer-Associated Thrombosis. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-.

3. Mahé I, Carrier M, Mayeur D, et al. Extended reduced-dose apixaban for cancer-associated venous thromboembolism. N Engl J Med. 2025; Epub online ahead of print.