Extended anticoagulant therapy with a reduced-dose of apixaban was noninferior to extended therapy with a full-dose of apixaban in preventing recurrent venous thromboembolism (VTE) in patients with active cancer and proximal deep-vein thrombosis or pulmonary embolism, based on findings from the API-CAT trial presented at ACC.25 in Chicago and simultaneously published in NEJM. In addition, patients receiving the reduced dose experienced a lower incidence of clinically relevant bleeding.

Researchers randomly assigned 1,766 patients to receive oral apixaban twice daily at a reduced dose of 2.5 mg or a full dose of 5 mg for 12 months. All participants had active cancer and had completed at least six months of anticoagulant therapy following proximal deep-vein thrombosis or pulmonary embolism. The primary outcome was centrally adjudicated fatal or nonfatal recurrent VTE, followed by clinically relevant bleeding as a key secondary outcome.

Recurrent VTE occurred in 18 patients (cumulative incidence, 2.1%) receiving the reduced dose of apixaban and in 24 patients (cumulative incidence, 2.8%) receiving the full dose (p=0.001 for noninferiority). Clinically relevant bleeding occurred in 102 patients (cumulative incidence, 12.1%) in the reduced-dose group and in 136 (cumulative incidence, 15.6%) in the full-dose group (p=0.03). Mortality was also lower (17.7%) among those in the reduced-dose group compared with those in the full-dose group (19.6% ).

"The best way to prevent a VTE recurrence after six months of anticoagulant treatment has not been clear," said Isabelle Mahé, MD, PhD, principal investigator of the study. "Our study has shown for the first time that a 12-month extension of anticoagulant treatment with reduced-dose apixaban was comparable to full-dose apixaban in preventing a recurrence of VTE in patients with active cancer who have already received at least six months of VTE treatment," she said.

In a related editorial published in NEJM, Simon Noble, MD, writes that "the additional value of the results of the API-CAT trial lies with the investigators' decision to report patient-relevant bleeding outcomes."

"This reporting provides clinicians with much-needed information for them to engage in meaningful dialogue with patients in order to make anticoagulation decisions that are based on patients' values and preferences," he said.