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Published on: February 28, 2012
Low-Dose Rivaroxaban to Prevent Left Ventricular Thrombosis After Anterior Myocardial Infarction: The APERITIF
Etienne Puymirat1,2,3, Gilles Soulat4,5, Benoit Lattuca3,6
1Department of Cardiology, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.
Insights
Adding low-dose rivaroxaban to dual antiplatelet therapy (DAPT) did not significantly reduce left ventricular (LV) thrombus in anterior ST-elevation myocardial infarction (STEMI) patients. However, it did increase minor bleeding events, warranting cautious interpretation due to study limitations.
Area of Science:
- Cardiology
- Clinical Trials
- Pharmacology
Background:
- Anterior acute myocardial infarction (MI) increases the risk of left ventricular (LV) thrombus formation.
- The efficacy and safety of adding oral anticoagulants to dual antiplatelet therapy (DAPT) for LV thrombus prevention post-anterior STEMI are not well-established.
Purpose of the Study:
- To evaluate if low-dose rivaroxaban added to DAPT reduces LV thrombus incidence at 1 month in anterior ST-segment elevation myocardial infarction (STEMI) patients.
- To assess the safety profile, including major and minor bleeding events, of this combined therapy.
Main Methods:
- A multicenter, open-label, blinded-endpoint randomized clinical trial involving 560 patients with anterior STEMI.
- Participants received either DAPT plus rivaroxaban (2.5 mg twice daily for 4 weeks) or DAPT alone.
- The primary endpoint was LV thrombus detection via contrast-enhanced cardiac magnetic resonance imaging at 1 month.
Main Results:
- LV thrombus was detected in 13.7% of patients receiving rivaroxaban plus DAPT versus 16.6% receiving DAPT alone (P=.34).
- No significant difference was observed in LV thrombus size or major adverse cardiovascular events between groups.
- Major bleeding events were comparable, but minor bleeding (BARC type 1) occurred more frequently in the rivaroxaban group (16.4% vs 7.2%).
Conclusions:
- Addition of low-dose rivaroxaban to DAPT did not significantly reduce LV thrombus formation in anterior STEMI patients at 1 month.
- The combination therapy led to a higher incidence of minor bleeding events.
- Findings should be interpreted cautiously due to the study's limited power; a modest effect cannot be excluded.
Importance:
Anterior acute myocardial infarction is associated with increased risk of left ventricular (LV) thrombus. The benefit and risk of adding an oral anticoagulant to dual antiplatelet therapy (DAPT) in preventing LV thrombus remain uncertain.
Objective:
To determine whether the addition of low-dose rivaroxaban to DAPT reduces the incidence of LV thrombus at 1 month in patients with anterior ST-segment elevation myocardial infarction (STEMI).
Design, Setting, And Participants:
This multicenter, open-label, blinded-end point randomized clinical trial was performed in 29 centers in France. The trial was nested in the ongoing FRENCHIE (French Cohort of Myocardial Infarction Evaluation) registry. Between October 2021 and January 2023, patients with anterior STEMI were enrolled. The last date of participant follow-up was in March 2023. Data analysis was performed from September 2024 to July 2025.
Interventions:
Patients were randomized to receive either DAPT plus rivaroxaban, 2.5 mg, twice daily for 4 weeks (n = 283) or DAPT alone (aspirin ≤100 mg per day and either clopidogrel, 75 mg per day, or ticagrelor, 90 mg twice a day [n = 277]), as soon as possible following completion of the initial percutaneous coronary intervention or angiography procedure.
Main Outcomes And Measures:
The primary end point was presence of LV thrombus on contrast-enhanced cardiac magnetic resonance imaging at 1 month.
Results:
Among 560 patients with anterior STEMI enrolled (mean [SD] age, 61.1 [11.6] years; 121 female patients [21.6%]), LV thrombus was detected in 38 patients (13.7%) receiving rivaroxaban and 47 patients (16.6%) with DAPT alone (difference, -2.9%; 95% CI, -8.9% to 3.2%; P = .34). No difference was observed between the 2 groups regarding the largest diameter of LV thrombus or the incidence of major adverse cardiovascular events. The incidence of major bleeding events (Bleeding Academic Research Consortium [BARC] ≥type 2) was also comparable (4 [1.5%] with DAPT plus rivaroxaban vs 2 [0.7%] with DAPT alone; difference, 0.7%; 95% CI, -1.3% to 3.1%), whereas minor bleeding events (BARC type 1) occurred more frequently in the DAPT plus rivaroxaban group (45 [16.4%] vs 20 [7.2%]; difference, 9.3%; 95% CI, 3.6%-14.8%).
Conclusions And Relevance:
In this multicenter randomized clinical trial among patients with anterior STEMI, the addition of low-dose rivaroxaban to DAPT did not demonstrate a statistically significant reduction in LV thrombus formation at 1 month but did increase minor bleeding. Given the limited power of the study, these findings should be interpreted with caution, as a modest effect cannot be excluded.
Trial Registration:
ClinicalTrials.gov Identifier: NCT05077683.
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