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Apixaban in Patients With Post-Myocardial Infarction Left Ventricular Thrombus: A Randomized Clinical Trial
Ali A Youssef1,2, Mustafa A Alrefae1, Hesham H Khalil1,3
1Saud Albabtain Cardiac Centre, Dammam, Saudi Arabia.
Insights
Apixaban effectively treats left ventricular thrombus (LVT) after myocardial infarction (MI), showing non-inferiority to warfarin. This study confirms apixaban
Area of Science:
- Cardiology
- Pharmacology
Background:
- Direct oral anticoagulants (DOACs) are standard for treating left ventricular thrombus (LVT) post-myocardial infarction (MI).
- Evaluating apixaban against warfarin for post-MI LVT is crucial for treatment optimization.
Purpose of the Study:
- To compare the efficacy and safety of apixaban versus warfarin in resolving post-MI LVT.
- To assess LVT resolution rates and adverse events in patients receiving apixaban or warfarin.
Main Methods:
- An open-label, randomized controlled trial involving patients with post-MI LVT confirmed by echocardiography.
- Patients received either apixaban or warfarin alongside dual antiplatelet therapy.
- Primary endpoint: LVT resolution at 3 months; Secondary endpoint: Major adverse cardiovascular events (MACE) and bleeding events (BARC classification).
Main Results:
- Apixaban demonstrated non-inferiority to warfarin in LVT resolution at 3 months (76.0% vs. 80.0%, P < 0.036).
- No significant differences in LVT resolution rates were observed at 1, 3, or 6 months between the groups.
- Warfarin-treated patients experienced longer hospital stays and more outpatient visits; no MACE occurred, and one BARC-2 bleeding event was reported with warfarin.
Conclusions:
- Apixaban is a safe and effective alternative to warfarin for treating post-MI LVT.
- Apixaban offers comparable efficacy to warfarin in LVT resolution, with potential benefits in healthcare resource utilization.
Background:
Direct oral anticoagulants are frequently used to treat post-myocardial infarction (MI) left ventricular thrombus (LVT). This study was conducted to evaluate the efficacy and safety of use of apixaban, compared to the standard warfarin therapy, in post-MI LVT.
Methods:
This open-label, randomized controlled trial included patients with post-acute or recent anterior wall MI with transthoracic echocardiography-confirmed LVT. Patients were randomized to receive either apixaban 5 mg twice daily or warfarin to achieve an international normalized ratio of 2-3, in addition to dual antiplatelet therapy. The primary endpoint was LVT resolution at 3 months, with a noninferiority margin of 95% for apixaban compared to warfarin. The secondary endpoint was major adverse cardiovascular events (MACE) or any relevant bleeding according to the Bleeding Academic Research Consortium (BARC) classification.
Results:
Fifty patients were enrolled from 3 centres. The use of dual or single antiplatelet agents was similar in the 2 groups. The number of 1-, 3-, and 6-month LVT resolutions were 10 (40.0%), 19 (76.0%), and 23 (92.0%) in the apixaban group, and 14 (56%), 20 (80.0%), and 24 (96.0%) in the warfarin group, respectively, without significant differences (P < 0.036 for noninferiority at 3 months). Patients taking warfarin required longer hospital stays and more outpatient visits. Multivariate adjustment analysis revealed left ventricular aneurysm, larger baseline LVT area and lower left ventricular ejection fraction to be independent predictors of LVT persistence at 3 months. No MACE occurred in either group; 1 BARC-2 bleeding event occurred with warfarin.
Conclusions:
Apixaban was not inferior to warfarin in the resolution of post-MI LVT.
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