Work

Reduction of Thrombus Burden With Short‐Term, Low‐Dose Rivaroxaban Use in Acute Myocardial Infarction: The ARISE‐ARMYDA 7 Randomized Trial

Year: 2025

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: 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.

Source: Journal of the American Heart Association

DOI: 10.1161/jaha.125.041993