Use of dabigatran and rivaroxaban in non-valvular atrial fibrillation: one-year follow-up experience in an Italian centre

Abstract

Background: Direct oral anticoagulants (DOAC) have been shown to be non-inferior to traditional vitamin K antagonists in preventing stroke and arterial thromboembolism in patients with non-valvular atrial fibrillation. Nevertheless, it is mandatory to record side effects and individual adherence to DOAC treatment.

Materials and methods: In this single-centre experience, patients with non-valvular atrial fibrillation were prospectively observed after switching from a vitamin K antagonist to dabigatran or rivaroxaban. The efficacy, safety, and tolerability of the novel treatment, and adherence to it, were evaluated over a period of 1 year. Clinical data were integrated with records of haemorrhagic and non-haemorrhagic complications. All the subjects were given an anonymous self-report questionnaire on the degree of their adherence/satisfaction with the treatment.

Results: Of 196 patients with non-valvular atrial fibrillation (median age, 78.5 years) who switched from a vitamin K antagonist to DOAC, 178 completed the 1-year follow up, of whom 87 were given dabigatran and 91 rivaroxaban. The efficacy of the two DOAC was similar. Patients given dabigatran had a higher frequency (n=32) of non-haemorrhagic complications (OR: 3.3; 95% CI: 1.7-7.8), which occurred earlier (HR: 6.1; 95% CI: 3.0-12.6) than those (n=7) recorded in subjects on rivaroxaban. The degree of satisfaction with therapy was higher among patients on rivaroxaban (mean score 9.1, SD 1.0) than among those on dabigatran (mean score 8.7; SD 0.9; p=0.01).

Discussion: Overall, in this experience, DOAC were shown to be effective, safe alternatives to vitamin K antagonists. Nevertheless, compared with rivaroxaban, dabigatran resulted in a higher rate and earlier occurrence of non-haemorrhagic events, and a lower satisfaction score.

Figure 1

VAS questionnaire on adherence/satisfaction with DOAC therapy. VAS: visual analogue scale; DOAC:Direct oral anticoagulants.

Figure 2

Cumulative event-free survival in DOAC anticoagulated patients. Kaplan-Meier curve, showing cumulative event-free survival in DOAC anticoagulated patients taking dabigatran (solid line) or rivaroxaban (dotted line). DOAC: direct oral anticoagulants.

Figure 3

VAS adherence/satisfaction scores in patients on dabigatran or rivaroxaban. The numbers of patients with each score are reported above the columns. VAS: visual analogue scale.