Abstract
Direct oral anticoagulants (DOACs) represent the standard of care for stroke prevention in non-valvular atrial fibrillation (NVAF). However, suboptimal adherence and adverse drug events (ADEs) remain major clinical challenges in geriatric populations due to polypharmacy and age-related physiological changes. This prospective, randomized controlled trial evaluated the efficacy of a Clinical Pharmacist-Led Anticoagulation Management Program (CPAMP) compared to standard care in elderly NVAF patients (age ≥65 years) receiving DOAC therapy over a 12-month period. A total of 320 patients were randomized to either the CPAMP intervention group (n=160) or standard care (n=160). Primary outcomes included medication adherence measured by Proportion of Days Covered (PDC ≥80%) and total ADEs, including major and clinically relevant non-major bleeding (CRNMB). At 12 months, the CPAMP group demonstrated significantly higher DOAC adherence compared to standard care (PDC ≥80%: 89.4% vs. 71.9%, p < 0.001; mean PDC: 0.91 vs. 0.78, p < 0.001). Total ADEs were significantly lower in the CPAMP group (8.1% vs. 18.8%, p = 0.005), primarily driven by a reduction in CRNMB (5.0% vs. 12.5%, p = 0.018) and fewer emergency department visits (6.3% vs. 15.0%, p = 0.011). Ischemic stroke rates did not differ significantly between groups (1.3% vs. 2.5%, p = 0.446). Structured clinical pharmacist monitoring, individualized education, and routine drug interaction screening significantly enhance DOAC adherence and reduce preventable ADEs in elderly NVAF patients, highlighting the critical value of integrating specialized pharmaceutical care into outpatient anticoagulation management.
