Mario Schiavoni1, Maurizio Margaglione2, Antonella Coluccia1. 1. Centre for Haemophilia and Rare Bleeding Disorders, "I. Veris delli Ponti" Hospital, Lecce Health Authority, Lecce, Italy. 2. Genetic Medicine, Department of Clinical and Experimental Medicine - Polyclinic Hospital, Foggia, Italy.
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.
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.
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