INTRODUCTION: This study was designed to evaluate safety and efficacy of combined low dose aspirin and warfarin therapy following mechanical heart valve replacement. METHODS: A total of 1496 patients (686 males, mean age 35±8.5 years) undergoing mechanical heart valvular replacement were randomly divided into study (warfarin plus 75-100 mg aspirin) or control (warfarin only) group. International normalized ratio (INR) and prothrombin time was maintained at 1.8-2.5 and 1.5-2.0 times of the normal value, respectively. Thromboembolic events and major bleedings were registered during follow up. RESULTS: Patients were followed up for 24±9 months. The average dose of warfarin in the study and control group was 2.92±0.87 mg and 2.89±0.79 mg, respectively (p>0.05). The overall thromboembolic events in study group were lower than in control group (2.1% vs. 3.6%, p=0.044). No statistically significant differences were found in hemorrhage events (3.5% vs. 3.7%, p>0.05) or mortality (0.3% vs 0.4%, p>0.05) between the two groups. CONCLUSIONS: Following mechanical valve replacement, combined low dose aspirin and warfarin therapy was associated with a greater reduction in thromboembolism events than warfarin therapy alone. This combined treatment was not associated with an increase in the rate of major bleeding or mortality. Crown
RCT Entities:
INTRODUCTION: This study was designed to evaluate safety and efficacy of combined low dose aspirin and warfarin therapy following mechanical heart valve replacement. METHODS: A total of 1496 patients (686 males, mean age 35±8.5 years) undergoing mechanical heart valvular replacement were randomly divided into study (warfarin plus 75-100 mg aspirin) or control (warfarin only) group. International normalized ratio (INR) and prothrombin time was maintained at 1.8-2.5 and 1.5-2.0 times of the normal value, respectively. Thromboembolic events and major bleedings were registered during follow up. RESULTS:Patients were followed up for 24±9 months. The average dose of warfarin in the study and control group was 2.92±0.87 mg and 2.89±0.79 mg, respectively (p>0.05). The overall thromboembolic events in study group were lower than in control group (2.1% vs. 3.6%, p=0.044). No statistically significant differences were found in hemorrhage events (3.5% vs. 3.7%, p>0.05) or mortality (0.3% vs 0.4%, p>0.05) between the two groups. CONCLUSIONS: Following mechanical valve replacement, combined low dose aspirin and warfarin therapy was associated with a greater reduction in thromboembolism events than warfarin therapy alone. This combined treatment was not associated with an increase in the rate of major bleeding or mortality. Crown
Authors: Lauren V Huckaby; Laura M Seese; Thomas G Gleason; Ibrahim Sultan; Yisi Wang; Floyd Thoma; Arman Kilic Journal: J Thorac Dis Date: 2021-05 Impact factor: 2.895