Efficacy and safety of dabigatran in cirrhosis with chronic portal vein thrombosis: A randomized, placebo-controlled double-blind trial (DAB-PVT).

INTRODUCTION: Direct oral anticoagulants (DOACs) are emerging options for portal vein thrombosis (PVT) in cirrhosis, though their safety and efficacy remain uncertain. We evaluated the efficacy and safety of dabigatran for PVT recanalization. METHODS: Eighty-four patients with cirrhosis and PVT were prospectively randomized to receive dabigatran(n=42; 150 mg twice daily) or placebo(n=42) for 12 months. The primary endpoint was complete recanalization(CR) of the portal vein at 12 months. Secondary endpoints included safety, clinical outcomes, and changes in the liver disease severity scores and mortality. RESULTS: Patients were predominantly male(71.4%), with a mean age of 48.5± 9.1 years and median Child-Turcotte-Pugh(CTP) score of 8(7-8). Medium-to-large varices were present in 60.7%, prior variceal bleeding in 45.2%, and ascites in 54.8%. At 12 months, complete recanalization occurred in 27/42(64.3%) in dabigatran group compared to 9/42(21.4%) in the placebo group(p<0.001). On multivariable Cox regression, dabigatran treatment was independently associated with complete recanalization (adjusted HR, 4.35; 95% CI, 2.03-9.36; P<0.001), along with a more favorable baseline ALBI score (adjusted HR, 2.02; 95% CI, 1.02-4.01; P=0.044). Variceal bleeding episodes were less frequent with dabigatran (3 vs. 12; p = 0.008). Compared with placebo, patients receiving dabigatran showed greater improvement in CTP scores (ΔCTP -0.57 ± 1.17 vs. 0.19 ± 1.17; P=0.004) and ALBI scores (ΔALBI -0.29 ± 0.82 vs. 0.06 ± 0.49; P=0.020). Longitudinal mixed-effects analysis demonstrated significantly different trajectories for CTP and ALBI scores, whereas MELD trajectories were comparable between groups. CONCLUSION: In patients with Child-Pugh A/B cirrhosis and chronic PVT, dabigatran significantly increased complete portal vein recanalization compared with placebo with fewer bleeding events. The observed differences in clinical events and liver disease severity scores could be considered exploratory requiring evaluation in larger comparative studies.