Patients with active cancer who developed blood clot or venous thromboembolism (VTE) and undergoing hemostatic treatment for at least six months, followed by an additional 12 months of low-dose Apixaban, presented similar to VTE relapses and relationship with the same period. These findings from the API-CAT test were presented at the annual scientific meeting of the American Cardiology College (ACC.25).
VTEs are a common complication of cancer and the second leading cause of death in cancer patients after cancer itself. Cancer cells release substances that facilitate the formation of blood clots. Cancer treatment can also cause inflammation in the blood vessels and increase the risk of blood clots. In addition, surgery limits patients’ mobility and the use of invasive devices also helps explain the risk of VTE.
For patients with VTE cancer, international guidelines are a treatment with anticoagulants or blood treatment for at least six months and for as long as cancer remains active or cancer treatment continues. Studies have shown that, although the risk of repetitive VTE decreases somewhat after six months of anticoagulation, patients remain at a significant risk. However, studies also show that anticoagulant therapy can increase the risk of patients for bleeding.
The best way to avoid VTE repeat after six months of anticoagulation was not clear. ”
Isabelle Mahé, MD, PhD, Professor of Internal Medicine at Paris Cité University, Head of Internal Medicine at Paris Public Aid Hospitals
The purpose of the API-CAT test was to assess if the lower dose of Apixaban was comparable to the full dose to prevent VTE relapse in patients with active cancer who had completed at least six months of blood treatment with blood for a VTE. Researchers in the study also evaluated whether the low dose resulted in a reduced risk of bleeding compared to full dose.
In this randomized, international, double blind study, a total of 1,766 patients participated in the future in 11 countries. Their average age was 67 years old and 57% were women. They all had active cancer (breast cancer, 22.7%, colon cancer, 15.3%, prostate cancer, 9.3%, other cancers, 41.4%). 65.8% had metastatic cancer (cancer that had spread from the area where it began to other parts of the body) and 81.2% received concomitant cancer treatment during integration. The average time since the patient’s VTE was eight months. When enrollment, all patients had completed at least six months of anticoagulation.
Patients were randomly commissioned to undergo treatment either with 5 mg (2.5 mg twice daily, the reduced dose group) or 10 mg (5 mg twice daily, Apixaban’s full -dose group) for an additional 12 months. Neither the patients nor the doctors knew them which dose patients received until the end of the test. All deaths, suspected VTE relapses and suspicious episodes of bleeding during the test were reviewed by an independent group of doctors who also ignored who received patients with treatment. The main endpoint of the study was any relapse of VTE or death by VTE during the treatment period. The main secondary end point was a complex of high bleeding and any bleeding that required medical care.
In 12 months, 18 patients in the reduced dose group and 24 in the full dose group had a recurrent VTE (cumulative incidence of 2.1% and 2.8% respectively), a difference that was statistically significant for reduced dose inferiority compared to the full dose. Clinically relative bleeding that required medical care appeared in 102 patients in the reduced dose group compared to 136 patients in the full dose group (cumulative incidence of 12.1% and 15.6% respectively), a statistically significant reduction in reduced dose. The mortality rates were similar in the two groups (17.7% in the reduced dose group, 19.6% in the full dose group).
“We can say that the lower Apixaban dose is as effective and safer than the full dose,” Mahé said, adding that the results should lead to a guideline update that constitutes extensive treatment with a reduced dose of anticoagulant in this group of patients.
Study restrictions include the lack of guidance on how long anticoagulant treatment should continue beyond the 12 -month monitoring period of the study. Secondly, Mahé said, the study does not provide information about possible differences in efficiency or security between racial and ethnic groups, because France does not allow the collection of race and nationality of patients. In addition, patients with brain tumors were excluded from the study, so the results do not apply to them.
Mahé and her colleagues plan to publish a surveillance analysis of the findings according to the type of cancer patients and to investigate the decisive agents of bleeding.
The study was funded by the BMS-Pfizer Alliance. Bristol-Myers Squibb provided free to Apixaban. It was a study funded by a researcher coordinated with Publique des Hôpitaux de Paris (AP-HP). The study financier had no role in designing the study, data collection, data analysis, data interpretation or writing of the report.
This study was published simultaneously on the internet at New England Medicine newspaper at the time of the presentation.
