Management of bleeding and nonelective invasive procedures in patients receiving direct oral anticoagulants (DOACs): a 5-year single-center observational study

Abstract

Background

Guidelines exist for managing bleeding or nonelective invasive procedures in patients on direct oral anticoagulants (DOACs), but their clinical impact remains unclear.

Objectives

To describe the management of patients who had DOAC concentrations measured for bleeding or nonelective invasive procedures and to assess 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 nonelective 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 and 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 the bleeding group than in the procedural group (122 [IQR, 57-219] vs 55 [IQR, 25-127] ng/mL), but bleeding severity was not associated with drug levels. In bleeding patients, rivaroxaban concentrations were higher in those with adverse outcomes compared with those without (243 [IQR, 74-367] vs 88 [IQR, 35-199] ng/mL).

Conclusion

In a large cohort of patients who had DOAC concentrations measured at the time of a bleeding or a nonelective 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.