PO130 | HEMORRHAGIC AND THROMBOTIC COMPLICATIONS DURING DOACS TREATMENT: THE IMPORTANCE OF A REGULAR AND PROLONGED FOLLOW-UP
Abstract
Background and Aims. Direct Oral Anticoagulants (DOAC) are the recommended drugs to be employed in the primary and secondary prophylaxis of the cardioembolic risk in patients with Atrial Fibrillation (AF). Nevertheless, ischemic stroke and major bleeding are still important outcomes to be considered. In particular, adherence to therapy has generally been found unsatisfactory. The aim of this prospective observational study is to record the percentages of ischemic and hemorrhagic events in a relatively large cohort of patients regularly followed in our Hemostasis and Thrombosis Unit over a long follow-up period. Methods. A total of 570 patients (256 women and 314 men, median age 78, range 65-95 years) with AF have been regularly followed for a median follow-up of 5 years (range 0.5-12 years, 2741 patient/years). The DOACs employed were: apixaban (n=357, 62.6%), Rivaroxaban (n=67, 11.7%), Edoxaban (n=79, 13.8%), and dabigatran (n=67, 11.7%). The DOAC regimen was given at either the recommended full or reduced dose. All bleeding episodes and thrombotic events have been documented by objective evidence. Each follow-up visit has been made on clinical grounds, with laboratory tests including Hb, platelet count, estimated glomerular filtration rate, and liver function tests. Non-parametric ANOVA was utilized to compare the clinical events across all DOACs. Results. Major bleeding events was 33 (1.2x100/patients/year), spontaneous intracerebral hemorrhages were 4 (0.15 x 100 patients-years), while post-traumatic cerebral hemorrhages were 3 (2 subdural and 1 subarachnoid) (0.11 x 100 patients-years). Clinically relevant non-major bleeding episodes were 28 (0.2 x 100 patients-years). Thrombotic events were as follows: ischemic strokes (n=9), upper right embolic event (n=1), atrial thrombosis (n=1), transient ischemic attacks (n=4) (0.55 x 100 patients-years). No differences were found when all these clinical adverse events were compared among all four DOACs (Table). Conclusions. This prospective study demonstrates that all DOACs perform well when patients with AF are regularly followed and monitored in a Hemostasis and Thrombosis Unit over an extended follow-up period. The results are significantly better than those achieved in the registrative trials, underscoring the importance of periodic follow-up for these patients. The role of the Hemostasis and Thrombosis Unit is crucial in managing therapy, which often faces adherence issues when patients are left to manage their treatment independently after the initial prescription.
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BibTeX
@article{barcellona2026po130,
title = {{PO130 | HEMORRHAGIC AND THROMBOTIC COMPLICATIONS DURING DOACS TREATMENT: THE IMPORTANCE OF A REGULAR AND PROLONGED FOLLOW-UP}},
author = {Doris Barcellona},
journal = {Bleeding, Thrombosis and Vascular Biology},
year = {2026},
month = oct,
url = {https://www.btvb.org/btvb/article/view/946},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - PO130 | HEMORRHAGIC AND THROMBOTIC COMPLICATIONS DURING DOACS TREATMENT: THE IMPORTANCE OF A REGULAR AND PROLONGED FOLLOW-UP
AU - Doris Barcellona
PY - 2026
DA - 2026/10/26
JO - Bleeding, Thrombosis and Vascular Biology
UR - https://www.btvb.org/btvb/article/view/946
AB - Background and Aims. Direct Oral Anticoagulants (DOAC) are the recommended drugs to be employed in the primary and secondary prophylaxis of the cardioembolic risk in patients with Atrial Fibrillation (AF). Nevertheless, ischemic stroke and major bleeding are still important outcomes to be considered. In particular, adherence to therapy has generally been found unsatisfactory. The aim of this prospective observational study is to record the percentages of ischemic and hemorrhagic events in a relatively large cohort of patients regularly followed in our Hemostasis and Thrombosis Unit over a long follow-up period. Methods. A total of 570 patients (256 women and 314 men, median age 78, range 65-95 years) with AF have been regularly followed for a median follow-up of 5 years (range 0.5-12 years, 2741 patient/years). The DOACs employed were: apixaban (n=357, 62.6%), Rivaroxaban (n=67, 11.7%), Edoxaban (n=79, 13.8%), and dabigatran (n=67, 11.7%). The DOAC regimen was given at either the recommended full or reduced dose. All bleeding episodes and thrombotic events have been documented by objective evidence. Each follow-up visit has been made on clinical grounds, with laboratory tests including Hb, platelet count, estimated glomerular filtration rate, and liver function tests. Non-parametric ANOVA was utilized to compare the clinical events across all DOACs. Results. Major bleeding events was 33 (1.2x100/patients/year), spontaneous intracerebral hemorrhages were 4 (0.15 x 100 patients-years), while post-traumatic cerebral hemorrhages were 3 (2 subdural and 1 subarachnoid) (0.11 x 100 patients-years). Clinically relevant non-major bleeding episodes were 28 (0.2 x 100 patients-years). Thrombotic events were as follows: ischemic strokes (n=9), upper right embolic event (n=1), atrial thrombosis (n=1), transient ischemic attacks (n=4) (0.55 x 100 patients-years). No differences were found when all these clinical adverse events were compared among all four DOACs (Table). Conclusions. This prospective study demonstrates that all DOACs perform well when patients with AF are regularly followed and monitored in a Hemostasis and Thrombosis Unit over an extended follow-up period. The results are significantly better than those achieved in the registrative trials, underscoring the importance of periodic follow-up for these patients. The role of the Hemostasis and Thrombosis Unit is crucial in managing therapy, which often faces adherence issues when patients are left to manage their treatment independently after the initial prescription.
SN - 2785-5309
ER -