Rationale and design of the direct oral anticoagulants for prevention of left ventricular thrombus after anterior acute myocardial infarction (APERITIF) trial

Anterior acute myocardial infarction (AMI) is associated with an increased risk of left ventricular (LV) thrombus formation. We hypothesized that adding low-dose oral rivaroxaban to the usual antiplatelet regimen would reduce the risk of LV thrombus in patients with large AMI. APERITIF is an investi...

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Bibliographic Details
Published in:The American heart journal 2023-12, Vol.266, p.98-105
Main Authors: Puymirat, Etienne, Soulat, Gilles, Fayol, Antoine, Mousseaux, Elie, Montalescot, Gilles, Cayla, Guillaume, Steg, Philippe Gabriel, Berard, Laurence, Rousseau, Alexandra, Drouet, Élodie, Simon, Tabassome, Danchin, Nicolas
Format: Article
Language:English
Subjects:
Angiography
Anticoagulants
Antiplatelet therapy
Diameters
Heart
Medical imaging
Myocardial infarction
Observational studies
Prevention
Risk
Stroke
Thrombosis
Ventricle
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Summary:Anterior acute myocardial infarction (AMI) is associated with an increased risk of left ventricular (LV) thrombus formation. We hypothesized that adding low-dose oral rivaroxaban to the usual antiplatelet regimen would reduce the risk of LV thrombus in patients with large AMI. APERITIF is an investigator-initiated, multicenter randomized open-label, blinded end-point (PROBE) trial, nested in the ongoing “FRENCHIE” registry, a French multicenter prospective observational study, in which all consecutive patients admitted within 48 hours of symptom onset in a cardiac Intensive Care Unit (ICU) for AMI are included (NCT04050956). Among them, patients with anterior ST-elevation-myocardial infarction (STEMI) or very high-risk non- ST-elevation-myocardial infarction (NSTEMI) patients with involvement of the left anterior descending artery are randomized into 2 groups: Dual Antiplatelet Therapy (DAPT) alone or DAPT plus rivaroxaban 2.5mg twice daily for 4 weeks, started as soon as possible after completion of the initial percutaneous coronary intervention/angiography procedure. The primary endpoint is the presence of LV thrombus at 1 month, as detected by contrast enhanced CMR (CE-CMR). Secondary endpoints include LV thrombus dimension (greatest diameter), the rate of major bleedings and major cardiovascular events at 1 month. Based on estimated event rates, a sample size of 560 patients is needed to show superiority of DAPT plus rivaroxaban therapy versus DAPT alone, with 80% power. The APERITIF trial will determine whether, in patients with large AMIs, the use of rivaroxaban 2.5mg twice daily in addition to DAPT reduces LV thrombus formation, compared with DAPT alone. ClinicalTrials.gov Identifier: NCT05077683.
ISSN:0002-8703
1097-6744
DOI:10.1016/j.ahj.2023.09.005