{"id":138695,"date":"2025-03-29T16:54:50","date_gmt":"2025-03-29T20:54:50","guid":{"rendered":"https:\/\/cardiologynownews.org\/?p=138695"},"modified":"2026-01-28T17:59:49","modified_gmt":"2026-01-28T22:59:49","slug":"api-cat-trial-extended-reduced-dose-apixaban-non-inferior-to-full-dose-for-vte-in-cancer","status":"publish","type":"post","link":"https:\/\/cardiologynownews.org\/?p=138695","title":{"rendered":"API-CAT Trial: Extended Reduced-Dose Apixaban Non-Inferior to Full Dose for VTE  in Cancer"},"content":{"rendered":"<p><b>Key Points:<\/b><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Venous thromboembolism (VTE) is a leading cause of mortality in cancer patients<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Extended anticoagulation is recommended for cancer patients with VTE, but balancing efficacy and bleeding risk remains a challenge.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The API-CAT trial demonstrated that extended reduced-dose apixaban (2.5 mg twice daily) was non-inferior to full-dose apixaban (5 mg twice daily) in preventing VTE recurrence while significantly lowering bleeding risk.<\/span><\/li>\n<\/ul>\n<p><!--more--><\/p>\n<p><span style=\"font-weight: 400;\">Venous thromboembolism (VTE) is a frequent complication in cancer patients and the second most common cause of death in this population after cancer itself. The increased risk of clot formation among patient with cancer is multifactorial: cancer cells promote thrombosis, cancer treatments induce vascular inflammation, and factors such as surgery, limited mobility, and invasive medical devices further elevate VTE risk. Current guidelines recommend anticoagulation for at least six months in patients with cancer-associated VTE, with continued treatment advised for as long as the cancer remains active or cancer therapy is ongoing. However, prolonged anticoagulation increases bleeding risk, leaving uncertainty about the optimal dosing strategy beyond the initial treatment period.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">To address this gap, Professor Isabelle Mah\u00e9, MD, PhD, from Universit\u00e9 Paris Cit\u00e9, presented findings from the <\/span><a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMoa2416112\"><span style=\"font-weight: 400;\">API-CAT<\/span><\/a><span style=\"font-weight: 400;\"> trial at the 2025 American College of Cardiology\u2019s Annual Scientific Conference during a Late-Breaking Clinical Trials session, with simultaneous publication in <\/span><i><span style=\"font-weight: 400;\">The New England Journal of Medicine<\/span><\/i><span style=\"font-weight: 400;\">. This investigator-sponsored study, funded by the Bristol-Myers Squibb-Pfizer Alliance, evaluated whether a lower dose of apixaban could provide comparable efficacy to the full dose in preventing recurrent VTE while reducing bleeding risk in cancer patients who had already completed at least six months of anticoagulation therapy.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In this <\/span><a href=\"https:\/\/clinicaltrials.gov\/study\/NCT03692065\"><span style=\"font-weight: 400;\">randomized, double-blind, international trial<\/span><\/a><span style=\"font-weight: 400;\">, 1,766 patients with active cancer were enrolled across 11 countries<\/span><span style=\"font-weight: 400;\">. <\/span><span style=\"font-weight: 400;\">Participants, with a median age of 67 years, were randomized to receive either reduced-dose apixaban (2.5 mg twice daily) or full-dose apixaban (5 mg twice daily) for an additional 12 months following their initial six-month anticoagulant treatment period. The primary endpoint was the recurrence of VTE or VTE-related death, while the key secondary endpoint assessed major bleeding and clinically relevant bleeding requiring medical intervention.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">At 12 months, VTE recurrence was observed in 18 patients in the reduced-dose group and 24 patients in the full-dose group (cumulative incidence: 2.1% vs. 2.8%), meeting the pre-specified criteria for non-inferiority. Clinically relevant bleeding occurred in 102 patients receiving the reduced dose compared to 136 in the full-dose group (cumulative incidence: 12.1% vs. 15.6%), indicating a significant reduction in bleeding risk with the lower dose. Mortality rates were comparable between the groups (17.7% vs. 19.6%).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Discussing the trial results, Professor Mah\u00e9 stated, \u201cWe can now confidently say that lower-dose apixaban is both effective and safer than the full dose for extended anticoagulation in cancer patients with VTE.\u201d She added, \u201cThese findings should lead to an update in clinical guidelines recommending reduced-dose anticoagulation for this population.\u201d<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Despite the positive findings, the study had limitations. The optimal duration of anticoagulation beyond the 12-month follow-up remains unclear. Additionally, as France does not permit the collection of racial and ethnic data, potential differences in safety and efficacy across diverse patient populations could not be assessed. Patients with brain tumors were also excluded, limiting the applicability of findings to this subgroup.<\/span><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Key Points: Venous thromboembolism (VTE) is a leading cause of mortality in cancer patients Extended anticoagulation is recommended for cancer patients with VTE, but balancing efficacy and bleeding risk remains a challenge. The API-CAT trial demonstrated that extended reduced-dose apixaban (2.5 mg twice daily) was non-inferior to full-dose apixaban (5 mg twice daily) in preventing [&hellip;]<\/p>\n","protected":false},"author":40615,"featured_media":138696,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[898,8],"tags":[899,45,185],"ppma_author":[1069],"class_list":{"0":"post-138695","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-acc-2025","8":"category-news","9":"tag-acc-2025","10":"tag-conference","11":"tag-news","12":"author-hassan-adam-alhassan-md"},"authors":[{"term_id":1069,"user_id":40615,"is_guest":0,"slug":"hassan-adam-alhassan-md","display_name":"Hassan Adam Alhassan MD","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/8cc8318e58bf0ad1548b042cbb04e2e62466d8fe5780d7b1f138246f2c21b2b5?s=96&r=g","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/138695","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/users\/40615"}],"replies":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=138695"}],"version-history":[{"count":1,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/138695\/revisions"}],"predecessor-version":[{"id":138697,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/posts\/138695\/revisions\/138697"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=\/wp\/v2\/media\/138696"}],"wp:attachment":[{"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=138695"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=138695"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=138695"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/cardiologynownews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fppma_author&post=138695"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}