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.