Abstract / Summary
Background Guidelines exist for managing bleeding or non-elective invasive procedures in patients on direct oral anticoagulants (DOAC), but their clinical impact remains unclear. This study described the management of patients who had DOAC concentrations measured for bleeding or non-elective invasive procedures and assessed associations between guideline compliance, outcomes, and DOAC concentrations. Methods This retrospective, single-center study (2014–2018) included adult patients receiving dabigatran etexilate, rivaroxaban, or apixaban who required hospital care for bleeding or non-elective invasive procedures and had DOAC concentrations measured at the time of the event. Compliance with French and European guidelines was assessed. Adverse outcomes—a composite of all-cause mortality, worsening or new bleeding, and thrombotic events—were recorded until discharge. Results A total of 584 events (432 procedures, 152 bleeding episodes) in 547 patients were analyzed. Guideline compliance was 79% and showed no association with outcomes. Among 95 events treated with prothrombin complex concentrates, one thrombotic event occurred. DOAC concentrations were higher in bleeding than in procedural group (122 [57–219] vs 55 [25–127] ng.mL -1 ), but bleeding severity was not associated with drug levels. In bleeding patients, rivaroxaban concentrations were higher in those with adverse outcomes compared to those without (243 [74–367] vs 88 [35–199] ng.mL -1 ). Conclusion In a large cohort of patients who had DOAC concentrations measured at the time of a bleeding or a non-elective invasive procedure, compliance with guidelines was high and not associated with outcomes. In bleeding patients, rivaroxaban concentrations were higher in those with vs without adverse events.