Strategie antitrombotiche alternative nell’infarto miocardico acuto con elevato carico trombotico: uno studio randomizzato.

Abstract

Background: La gestione dello STEMI con elevato carico trombotico coronarico (LCTB) è complessa. Sebbene lo stenting differito migliori gli esiti, il regime antitrombotico ottimale è incerto. Lo studio ARISE-ARMYDA 7 ha valutato rivaroxaban a basse dosi + DAPT per ridurre il LCTB in questi pazienti.

Metodi: Studio pilota monocentrico, randomizzato, su pazienti STEMI con LCTB sottoposti a PCI primaria e stenting differito. I pazienti sono stati randomizzati a rivaroxaban 2.5 mg + aspirina/ticagrelor o solo aspirina/ticagrelor. Il carico trombotico è stato valutato tramite OCT al basale e dopo 5-7 giorni. Endpoint primario: riduzione del Thrombus Score.

Risultati: 40 pazienti randomizzati (1:1). Il Thrombus Score post-trattamento (OCT) era significativamente inferiore nel gruppo rivaroxaban (39 [27-52] vs 82 [50-111], p=0.005). La riduzione relativa del Thrombus Score era maggiore con rivaroxaban (61% vs 36%, p=0.002). Anche la riduzione relativa del Thrombus Volume era superiore (77% vs 39%, p=0.001). Lo stenting differito è stato sicuro, senza complicanze procedurali maggiori. Gli esiti clinici a 30 giorni (MACE, sanguinamenti) non hanno mostrato differenze significative.

Conclusioni: Il trial ARISE-ARMYDA 7 dimostra che l'aggiunta di rivaroxaban a basse dosi alla DAPT riduce significativamente il carico trombotico in pazienti STEMI con LCTB, mantenendo un profilo di sicurezza favorevole.

Background: Managing large coronary thrombus burden (LCTB) in patients with ST-segment elevation myocardial infarction (STEMI) remains challenging. While deferred stenting emerged to potentially improve outcomes in this high-risk population, the optimal antithrombotic regimen remains unclear. The ARISE-ARMYDA 7 trial evaluated low-dose rivaroxaban, in addition to dual antiplatelet therapy (DAPT), for LCTB reduction in STEMI patients managed with deferred stenting. Methods: This single-center, randomized, pilot study included STEMI patients with angiographic evidence of LCTB undergoing primary percutaneous coronary intervention (PCI) and deferred stenting. Patients were randomized to rivaroxaban 2.5 plus aspirin and ticagrelor or aspirin plus ticagrelor alone. Thrombus burden was assessed by optical coherence tomography (OCT) at baseline and after 5-7 days of treatment. Primary endpoint was reduction of Thrombus Score after this period. Results: A total of 40 patients with STEMI and LCTB were randomized 1:1. Post-treatment Thrombus Score at re-OCT imaging was significantly lower in the rivaroxaban arm (39 [27-52] vs 82 [50-111] in controls, p=0.005). Relative reduction of the Thrombus Score vs baseline was greater with rivaroxaban use (61% [50–81%] vs 36% [0–50%], p=0.002). The relative Thrombus Volume decrease was 77% with rivaroxaban vs. 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 MACE and bleeding complications, were not significantly different. Conclusions: The ARISE-ARMYDA 7 trial shows that adding low-dose rivaroxaban to DAPT significantly reduces thrombus burden in STEMI patients with LCTB, while maintaining a favorable safety profile.