Reduced-Dose Eliquis Gets the Nod in Study of Cancer Patients| ACC 2025

Cancer patients are living longer because of more effective, targeted therapy. But with that success has come the risk of blood clots, or venous thromboembolism, and researchers and clinicians are still figuring out the best approach to keep them from happening.

Results presented today to the American College of Cardiology’s Annual Scientific Session in Chicago may help solve one part of that puzzle, which is how to treat patients over the longer term. Isabelle Mahé, M.D., Ph.D., a professor of internal medicine at the Université Paris Cité and head of internal medicine at Public Assistance Hospitals of Paris, and her colleagues reported results that cancer patients receiving a reduced dose of Eliquis (apixaban) experienced less bleeding and similar blood clot recurrences as the patients who received a full dose of the direct-acting oral anticoagulant. For the purposes of this trial, a reduced dose was defined as 2.5 milligrams (mg) twice daily and the full dose as 5 mg twice daily.

Isabelle Mahé, M.D., Ph.D.

Mahé and her colleagues randomly assigned 866 patients to take the reduced dose of Eliquis and 900 to take the full dose. All of the participants had previously documented symptomatic or incidental acute proximal deep-vein thrombosis or pulmonary embolism that had been treated for six months with anticoagulant treatment. All had active cancer (breast cancer, 22.7%; colorectal cancer, 15.3%; prostate cancer, 9.3%; other cancers, 41.4%), and most (65.8%) had metastatic cancer. The median time since the blood clot that led to anticoagulant therapy was eight months. The outcomes comparing the reduced dose of Eliquis with the full dose were assessed after 12 months of treatment.

Results of the study, called API-CAT, were published simultaneously in the New England Journal of Medicine (NEJM) and shared at a late-breaking session at the cardiology meeting. The results reported by Mahé and her colleagues in NEJM showed that 18 (2.1%) of the 866 patients in the reduced-dose group had recurrence of a blood clot compared with 24 (2.8%) of the 900 patients in the full dose. The researchers had set recurrence of a blood clot as the primary efficacy endpoint of the trial.

The results for a major venous thromboembolism — defined as a pulmonary embolism or proximal deep-vein thrombosis — were similar: 17 (2%) affected in the reduced-dose group compared with 21 (2.4%) in the full-dose one.

The secondary safety outcomes concerning bleeding also favored the reduced-dose approach: 102 (12.1%) of those in the reduced-dose group experienced a major or “clinically relevant” nonmajor bleed compared with 136 (15.6%) in the full-dose group, according to the results published in NEJM. The differences in major bleeds (2.9% vs. 4.3%) and major gastrointestinal bleeds (1.4% vs. 2.9%) were consistent with the overall results, favoring the reduced-dose group.

The takeaway from the study, as Mahé and her colleagues expressed in the NEJM, is that the extended treatment with a reduced dose of Eliquis was “noninferior” to full-dose treatment, and that reduced dose resulted in a lower incidence of clinically relevant bleeding.

“We can say that the lower-dose apixaban is both effective and safer than the full dose,” Mahé said in an American College of Cardiology news release about the results.