A multicomponent intervention to prevent major bleeding complications in older patients receiving warfarin - A randomized, controlled trial

Background: warfarin is effective in the treatment and prevention of many v enous thromboembolic disorders, but it often leads to bleeding, Objective: To develop a multicomponent program of management of warfarin th erapy and to determine its effect on the frequency of warfarin-related majo r bleeding in older patients. Design: Randomized, controlled trial. Setting: University hospital in Cleveland, Ohio. Patients: 325 patients 65 years of age or older who started warfarin therap y during hospitalization. Interventions: Patients were stratified according to baseline risk for majo r bleeding and were randomly assigned to receive the intervention (n = 163) or usual care (n = 162) by their primary physicians for 6 months. The inte rvention consisted of patient education about warfarin, training to increas e patient participation, self-monitoring of prothrombin time, and guideline -based management of warfarin dosing, Measurements: Major bleeding, death, recurrent venous thromboembolism, and therapeutic control of anticoagulant therapy at 6 months. Results: In an intention-to-treat analysis, major bleeding was more common at 6 months in the usual care group than in the intervention group (cumulat ive incidence, 12% vs. 5.6%; P = 0.0498, log-rank test). The most frequent site of major bleeding in both groups was the gastrointestinal tract. Death and recurrent venous thromboembolism occurred with similar frequency in bo th groups at 6 months. Throughout 6 months, the proportion of total treatme nt time during which the international normalized ratio was within the ther apeutic range was higher in the intervention group than in the usual care g roup (56% vs. 32%; P < 0.001). After 6 months, major bleeding occurred with similar frequencies in the intervention and usual care groups. Conclusions: A multicomponent comprehensive program of warfarin management reduced the frequency of major bleeding in older patients. Although the gen eralizability and cost-effectiveness of this program remain to be demonstra ted, these findings support the premise that efforts to reduce the likeliho od of major bleeding will lead to safe and effective use of warfarin therap y in older patients.