Session: 332. Thrombosis and Anticoagulation: Clinical and Epidemiological: Poster III
Hematology Disease Topics & Pathways:
Anticoagulant Drugs, Treatment Considerations, Non-Biological therapies
Aim. To assess the effectiveness and safety of reduce dose of Apixaban compared to a cohort of VKA-treated patients for the secondary prevention (SP) of PVT. The effectiveness outcome was defined by recurrent/progression PVT. The safety outcome was defined by a first event of major bleeding, clinically relevant nonmajor bleeding, or all-cause death.
Methods. Unicenter, observational, and retrospective study, conducted between 2018 and 2023, enrolled patients over 18 years old with non-malignant portal vein thrombosis (PVT) who had completed 3-6 months of standard anticoagulant therapy. These patients transitioned to secondary prevention with either a reduced dose of Apixaban (2.5 mg twice daily) or vitamin K antagonists targeting an INR of 2-3. Exclusion criteria were malignant PVT and insufficient clinical data at PVT diagnosis or follow-up. We collected demographic, laboratory, and clinical data, including ascites and hepatic encephalopathy assessments using the Child-Pugh score at diagnosis and follow-up. Clinical progression during anticoagulation and its correlation with CT and MRI findings were reviewed by a multidisciplinary committee of hematologists, hepatologists, and interventional radiologists. The follow-up period, lasting at least 12 months, included assessments of recurrent PVT, major bleeding, non-major but clinically relevant bleeding (NMCR), and mortality.
Results. The study included 498 patients (54.6% women, mean age 56.6±19.1 years). Of these, 268 were treated with vitamin K antagonists (VKAs) (INR: 2-3, mean TTR: 59%), and 230 were treated with Apixaban (2.5 mg twice daily) (58.7% women). The mean follow-up from the initiation of secondary prevention to the last visit was 26.5±14.5 months. A significant proportion of patients (67%) had a Child-Pugh score of B or C.
Patients treated with VKAs had a higher rate of PVT recurrences/progression (6.7% vs. 2.1%; P < 0.003) and major bleeding (8.2% vs. 1.7%; P < 0.001) compared to those treated with Apixaban. In the VKA group, the risk of bleeding was associated with a platelet count of less than 50x10^3/mm^3 (OR=8.266; 95% CI: 2.310-39.211; p=0.002) and a TTR <50% (HR=1.726; 95% CI: 1.310-2.511; p=0.002). Survival rates were better in the Apixaban group (88.4% vs. 68.7% at 2 years and 92.7% vs. 77.8% at 1 year; p=0.038). Multivariable analysis adjusted for competing risks revealed that cirrhotic patients on VKAs had an increased risk of major bleeding (Hazard Ratio, HR 1.816; 95% CI: 1.392-2.190) and progression of PVT (HR 1.543; 95% CI: 1.126-1.942)
Conclusions. In cirrhotic patients with chronic portal PVT, VKAs were associated with a 5-fold higher rate of PVT recurrences/progression and a 3-fold higher rate of major bleeding compared to reduced-dose Apixaban. Additionally, survival was better in the Apixaban group. These findings suggest that reduced-dose Apixaban is a safer and more effective option for SP in this population. Further prospective studies are needed to confirm these results.
Disclosures: Campoy: Bayer: Honoraria; Pfizer: Honoraria; Boehringer Ingelheim: Honoraria; Daiichi Sankyo: Honoraria; Roche: Honoraria; Bristol Myers Squibb: Honoraria; Sanofi: Honoraria. Artaza: Bayer: Honoraria; Pfizer: Honoraria; Boehringer Ingelheim: Honoraria; Daiichi Sankyo: Honoraria; Roche: Honoraria; Bristol Myers Squibb: Honoraria; Sanofi: Honoraria. Bosch: Genentech: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: payment for expert testimony; Gilead: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: payment for expert testimony; Lava Therapeutics: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: payment for expert testimony; TG Therapeutics: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: payment for expert testimony; Enterome: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: payment for expert testimony; Advantage Allogene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: payment for expert testimony; AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: payment for expert testimony; BeiGene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: payment for expert testimony; Lilly: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: payment for expert testimony; AstraZeneca: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: payment for expert testimony; Celgene/BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: payment for expert testimony; Mundipharma: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: payment for expert testimony; Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: payment for expert testimony; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: payment for expert testimony; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: payment for expert testimony; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: payment for expert testimony. Olivera: Bayer: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Boehringer Ingelheim: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Sanofi: Honoraria; Roche: Honoraria; Bristol Myers Squibb: Honoraria, Research Funding; Daiichi Sankyo: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding.
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