Apiksaban with a reduced dose turns out to be effective in preventing blood clots in patients with cancer

Patients with active cancer who developed a blood clot or venous thrombosis (VTE) and were treated with blood thinning drugs for at least six months, and then an additional 12 months of Apiksaban in low dose, experienced similar VTE relapses and less bleeding as similar patients who received a fully dose of oral drugs in the same long period. These findings from the API-CAT study were presented at the annual American College of Cardiology (ACC.25) scientific session.

VTE is a common complication of cancer and the second leading cause of death in patients with cancer after cancer. Cancer cells release substances that facilitate the formation of blood clots. Cancer treatment can also cause inflammation In blood vessels and increasing the risk of blood clots. In addition, the operation limits patients’ mobility, and the use of invasive devices also helps explain the risk of VTE.

In the case of patients with cancer who develop VTE, international guidelines recommend treatment with anticoons or blood drugs, for at least six months and as long as cancer remains active or cancer treatment is underway. Studies have shown that although the risk of recurring echination slightly decreases after six months of anticoagulant treatment, patients remain threatened. However, studies also show that anticoagulant treatment can increase the risk of patient bleeding.

The best way to prevent recurrence of VSZ after six months of anticoagulant treatment was not clear. “

Isabelle Mahé, dr MD, professor of internal medicine at the Université Paris Cité, head of internal medicine at Public Assistance Hospitals of Paris

The purpose of the API-CAT study was to assess whether the lower dose of apixaban was comparable to the full dose in preventing recurrence of ŻRZZ in patients with active cancer who have completed at least six months of treatment with blood thinning drugs for VTE. Research researchers also assessed whether the low dose caused a reduction in the risk of bleeding compared to the full dose.

In this randomized, international, double -blind study, a total of 1,766 patients were prospectively enrolled in 11 countries. Their average age was 67 years, and 57% are women. They all had active cancer (breast cancer, 22.7%; colorectal cancer, 15.3%; prostate cancer, 9.3%; other cancer, 41.4%); 65.8% had cancer with metastases (cancer, which spread from the place where it began to other parts of the body), and 81.2% received simultaneous treatment of cancer when switching on. The median time from VTE patients was eight months. During recruitment, all patients graduated from at least six months of anticoagulant treatment.

Patients were randomly assigned to treat 5 mg (2.5 mg twice a day; a group with a reduced dose) or 10 mg (5 mg twice a day; full dose group) Apiksaban for an additional 12 months. Neither patients nor their doctors knew which dose patients receive until the end of the examination. All deaths, suspected of VTE relapses and suspected episodes of bleeding during the examination were checked by an independent group of doctors who were also not aware of which patients of treatment. The primary end point of the study was all recurrence of ZSZZ or death because of the VSZ during the treatment period. The key secondary end point was the complex bleeding and all bleeding that required medical care.

After 12 months of 18 patients in a group with a reduced dose and 24 in the full dose group had a recurrent VSZ (12-month-old scored incidence of 2.1% and 2.8%), the difference, which was statistically important for non-maneura reduced dose compared to the full dose. Clinically significant bleeding requiring medical care occurred in 102 patients in a group with a reduced dose compared to 136 patients in a full dose group (12-month accumulated incidence of 12.1% and 15.6% respectively, respectively), which is statistically significant reduction in favor of a reduced dose. Death rates were similar in two groups (17.7% in a reduced dose group, 19.6% in the full dose group).

“We can say that Apiksaban from a lower dose is both effective and safer than a full dose,” said Mahé, adding that the results should lead to the updates of guidelines recommending prolonged anti -coagulant treatment with a reduced dose in this group of patients.

Study restrictions include no tips on how long anticoagulant treatment should last outside the 12-month examination period. Secondly, Mahé said, the study does not contain information about possible differences in efficiency or safety between racial and ethnic groups, because France does not allow the collection of data on the patients’ breed and ethnic origin. 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 control analysis of results according to the type of patients with cancer and have examined the determinants of bleeding.

The study was financed by BMS-PFizer Alliance. Bristol-Myers Squibb provided Apixaban for free. This was a sponsored study by a researcher coordinated by Publicque des Hôpitaux de Paris (AP-HP). The study founder had no role in research design, data collection, data analysis, data interpretation or writing a report.

This study was simultaneously published online during the presentation.