R J Beyth1, L Quinn, C S Landefeld. 1. Baylor College of Medicine, Section of Health Services Research, Houston Center for Quality of Care and Utilization Studies, Veterans Affairs Medical Center (152), Building 110T, 2002 Holcombe Boulevard, Houston, TX 77030, USA. rbeyth@bcm.tmc.edu
Abstract
BACKGROUND:Warfarin is effective in the treatment and prevention of many venous thromboembolic disorders, but it often leads to bleeding. OBJECTIVE: To develop a multicomponent program of management of warfarin therapy and to determine its effect on the frequency of warfarin-related major 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 therapy during hospitalization. INTERVENTIONS:Patients were stratified according to baseline risk for major bleeding and were randomly assigned to receive the intervention (n = 163) or usual care (n = 162) by their primary physicians for 6 months. The intervention consisted of patient education about warfarin, training to increase 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 (cumulative 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 both groups at 6 months. Throughout 6 months, the proportion of total treatment time during which the international normalized ratio was within the therapeutic range was higher in the intervention group than in the usual care group (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 generalizability and cost-effectiveness of this program remain to be demonstrated, these findings support the premise that efforts to reduce the likelihood of major bleeding will lead to safe and effective use of warfarin therapy in older patients.
RCT Entities:
BACKGROUND:Warfarin is effective in the treatment and prevention of many venous thromboembolic disorders, but it often leads to bleeding. OBJECTIVE: To develop a multicomponent program of management of warfarin therapy and to determine its effect on the frequency of warfarin-related major 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 therapy during hospitalization. INTERVENTIONS:Patients were stratified according to baseline risk for major bleeding and were randomly assigned to receive the intervention (n = 163) or usual care (n = 162) by their primary physicians for 6 months. The intervention consisted of patient education about warfarin, training to increase 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 (cumulative 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 both groups at 6 months. Throughout 6 months, the proportion of total treatment time during which the international normalized ratio was within the therapeutic range was higher in the intervention group than in the usual care group (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 generalizability and cost-effectiveness of this program remain to be demonstrated, these findings support the premise that efforts to reduce the likelihood of major bleeding will lead to safe and effective use of warfarin therapy in older patients.
Authors: Marc Ruivard; Christine Berger; Abdellaziz Achaibi; Claude Campagne; Pierre Philippe Journal: J Gen Intern Med Date: 2003-11 Impact factor: 5.128
Authors: Daniel M Witt; Robby Nieuwlaat; Nathan P Clark; Jack Ansell; Anne Holbrook; Jane Skov; Nadine Shehab; Juliet Mock; Tarra Myers; Francesco Dentali; Mark A Crowther; Arnav Agarwal; Meha Bhatt; Rasha Khatib; John J Riva; Yuan Zhang; Gordon Guyatt Journal: Blood Adv Date: 2018-11-27