Summary
Although many patients with long-term oral anticoagulation (OAC) can manage their
medication safely and reliably themselves, no study on elderly patients has as yet
assessed the safety and efficacy of OAC self-management with major thromboembolic
and haemorrhagic complications as primary outcomes. In this multi-centre trial, patients
aged 60 years or more were randomised into a self-management (SMG) (N=99) or routine
care group (RCG) (N=96).The primary outcome was the combined endpoint of all thromboembolic
events requiring hospitalisation and all major bleeding complications. Mean follow-up
was 2.9 ± 1.2 and 3.0 ± 1.1 years in the SMG and RCG, respectively. In intention-to-treat
analysis, 12 patients in the SMG versus 22 patients in the RCG reached a primary endpoint
(hazard ratio [HR]: 0.50; 95% confidence interval [CI]: 0.25 to 1.00; p=0.049).
Keywords
Oral anticoagulation - self-management - elderly patients - randomized controlled
trial