Safety and effectiveness of dabigatran vs rivaroxaban in nonvalvular atrial fibrillation patients at nutritional risk.

BACKGROUND: Malnutrition is a prevalent comorbidity in nonvalvular atrial fibrillation (NVAF), yet comparative evidence on oral anticoagulants in this vulnerable population is scarce. OBJECTIVES: We aimed to compare the safety and effectiveness of dabigatran with those of rivaroxaban in NVAF patients at nutritional risk. METHODS: This new-user, active-comparator cohort study utilized data from the Tianjin Health and Medical Data Platform (2015-2020). We identified 10,658 NVAF patients (dabigatran n = 1819; rivaroxaban n = 8839) at nutritional risk, defined as a Prognostic Nutritional Index score ≤50. Multivariable Cox proportional hazards models were used to compare the risks of intracranial hemorrhage (ICH), gastrointestinal bleeding, ischemic stroke, and all-cause mortality over a maximum 3-year follow-up. Extensive sensitivity analyses were performed to ensure the robustness of the findings. RESULTS: The incidence of ICH was significantly lower in the dabigatran group compared with the rivaroxaban group (0.55% vs 1.27%; hazard ratio [HR], 0.42; 95% CI, 0.22-0.80). This lower risk was particularly evident in patients receiving low-dose regimens (HR, 0.33; 95% CI, 0.16-0.69) and was consistent in short-term analyses. There were no significant differences between the 2 groups in the risks of gastrointestinal bleeding (HR, 0.99; 95% CI, 0.72-1.35), ischemic stroke (HR, 1.06; 95% CI, 0.86-1.31), or all-cause mortality (HR, 0.93; 95% CI, 0.80-1.09). CONCLUSION: In NVAF patients at nutritional risk, dabigatran was associated with a lower risk of ICH compared with rivaroxaban, without compromising effectiveness.