Registry of antithrombotic therapy in atrial fibrillation patients with bioprosthetic valves: A retrospective observational study.

BACKGROUND

The incidence of cardiovascular diseases, including valvular heart disease and atrial fibrillation (AF), is rising as the elderly population increases. For patients with AF and bioprosthetic valves, current treatment guidelines for antithrombotic therapy vary by country, likely due to a lack of robust study data.

METHODS

We conducted a multicenter, retrospective, observational analysis of 214 Japanese AF patients after bioprosthetic valve replacement in real-world clinical practice. The primary efficacy endpoint was the incidence of stroke/systemic embolism, and the primary safety endpoint was major bleeding.

RESULTS

The mean observation period was 46.0 months. Warfarin was administered to 176 patients (82.2%), direct oral anticoagulants (DOAC) to 16 patients (7.5%), and antiplatelet drugs to 13 patients (6.1%). The number of patients who were treated with DOAC was increasing in the later period of registration. Stroke/systemic embolism was observed in 14 patients [1.77 patients/100 person-years (PY)]. Major bleeding was observed in 22 patients (2.83/100 PY).

CONCLUSIONS

In a current real-world setting in Japan, warfarin was the most commonly used treatment in AF patients with bioprosthetic valves, but there was an increasing trend of DOAC-treated patients. Further investigations are needed to confirm the efficacy and safety of DOAC in patients with bioprosthetic valves.