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Reduction of Thrombus Burden With Short-Term, Low-Dose Rivaroxaban Use in Acute Myocardial Infarction: The
Marco G Mennuni1,2, Leonardo Grisafi2, Gianluca Anastasia3,4
1Department of Translational Medicine University of Eastern Piedmont Novara Italy.
Insights
Adding low-dose rivaroxaban to dual antiplatelet therapy significantly reduced large coronary thrombus burden in STEMI patients undergoing deferred stenting. This regimen demonstrated a favorable safety profile in the ARISE-ARMYDA 7 pilot study.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- Managing large coronary thrombus burden (LCTB) in ST-segment-elevation myocardial infarction (STEMI) is challenging.
- Deferred stenting is a strategy for STEMI patients with LCTB, but optimal antithrombotic therapy is unclear.
- The ARISE-ARMYDA 7 trial investigated low-dose rivaroxaban in this patient group.
Purpose of the Study:
- To evaluate the efficacy and safety of adding low-dose rivaroxaban to dual antiplatelet therapy (DAPT) for LCTB reduction in STEMI patients undergoing deferred stenting.
- To assess the impact of rivaroxaban on thrombus burden reduction using optical coherence tomography (OCT).
Main Methods:
- A single-center, randomized pilot study included STEMI patients with LCTB undergoing primary PCI and deferred stenting.
- Patients received either rivaroxaban 2.5 mg BID plus aspirin and ticagrelor, or aspirin and ticagrelor alone.
- Thrombus burden was quantified by OCT at baseline and after 5-7 days; the primary endpoint was thrombus score reduction.
Main Results:
- The rivaroxaban group showed a significantly lower post-treatment thrombus score compared to controls (39 vs. 82, P=0.005).
- Relative thrombus score reduction was greater with rivaroxaban (61% vs. 36%, P=0.002), and thrombus volume decreased by 77% vs. 39% (P=0.001).
- Deferred stenting was safe; no significant differences in 30-day MACE or bleeding were observed between groups.
Conclusions:
- Adding low-dose rivaroxaban to DAPT significantly reduces thrombus burden in STEMI patients with LCTB managed with deferred stenting.
- This combination therapy appears safe, with no increase in major adverse cardiovascular events or bleeding.
- The findings support further investigation of rivaroxaban-based regimens in this high-risk population.
Background:
Managing large coronary thrombus burden (LCTB) in patients with ST-segment-elevation myocardial infarction (STEMI) remains challenging. Although deferred stenting emerged to potentially improve outcomes in this high-risk population, the optimal antithrombotic regimen remains unclear. The ARISE-ARMYDA 7 (Alternative Anti-Thrombotic Pathways in Acute Myocardial Infarction-Antiplatelet Therapy for Reduction of Myocardial Damage 7) trial evaluated low-dose rivaroxaban in addition to dual antiplatelet therapy for LCTB reduction in patients with STEMI managed with deferred stenting.
Methods:
This single-center, randomized, pilot study included patients with STEMI with angiographic evidence of LCTB undergoing primary percutaneous coronary intervention and deferred stenting. Patients were randomized to rivaroxaban 2.5 mg BID plus aspirin and ticagrelor or aspirin plus ticagrelor alone. Thrombus burden was assessed by optical coherence tomography at baseline and after 5 to 7 days of treatment. The primary end point was reduction of thrombus score after this period.
Results:
A total of 40 patients with STEMI and LCTB were randomized 1:1. Posttreatment thrombus score at re-optical coherence tomography imaging was significantly lower in the rivaroxaban arm (39 [27-52] versus 82 [50-111] in controls, P=0.005). Relative reduction of the thrombus score versus baseline was greater with rivaroxaban use (61% [50%-81%] versus 36% [0%-50%], P=0.002). The relative thrombus volume decrease was 77% with rivaroxaban versus 39% in the control arm (P=0.001). Deferred stenting was safe, with no abrupt vessel closures, distal embolization, or no reflow. Clinical outcomes at 30 days, including major adverse cardiovascular events and bleeding complications, were not significantly different.
Conclusions:
The ARISE-ARMYDA 7 trial shows that adding low-dose rivaroxaban to dual antiplatelet therapy significantly reduces thrombus burden in patients with STEMI with LCTB, while maintaining a favorable safety profile.
Registration:
URL: https://www.clinicaltrialsregister.eu/; Unique identifier: EudraCT 2020-005156-38.
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