In patients with anterior ST-segment elevation myocardial infarction, adding low-dose rivaroxaban to dual antiplatelet therapy did not reduce the rate of left ventricular thrombus detected by cardiac magnetic resonance imaging at 1 month compared with dual antiplatelet therapy alone, according to the APERITIF randomized clinical trial published in JAMA Cardiology.
Among 560 patients treated at 29 centers in France, left ventricular thrombus was detected in 14% of patients assigned to dual antiplatelet therapy plus rivaroxaban and 17% of patients assigned to dual antiplatelet therapy alone. The difference between groups was not statistically significant, and the trial did not meet its primary end point.
The multicenter trial used an open-label design with blinded assessment of outcomes and was conducted within the FRENCHIE registry. Eligible participants were adults with anterior ST-segment elevation myocardial infarction, anterior wall motion abnormalities on echocardiography, and a culprit lesion in the proximal or mid–left anterior descending artery.
Patients were excluded if left ventricular thrombus was detected on baseline echocardiography, if they had a high bleeding risk, or if they had contraindications to cardiac magnetic resonance imaging. Randomization occurred after primary percutaneous coronary intervention.
All patients received aspirin plus either clopidogrel or ticagrelor. Prasugrel was not permitted. Patients assigned to the intervention group also received rivaroxaban at a dose of 2.5 mg twice daily for 4 weeks.
Cardiac magnetic resonance imaging was performed about 1 month after the index event to assess for left ventricular thrombus. Missing imaging data were counted as thrombus in the primary analysis.
Baseline characteristics were similar between groups. The mean age of participants was 61 years, and 22% were women. The median left ventricular ejection fraction was about 45%.
Prespecified subgroup analyses showed consistent findings across patient characteristics, including age, sex, cardiovascular risk profile, time to revascularization, left ventricular ejection fraction, and type of P2Y12 inhibitor used.
Exploratory analyses suggested differences according to antithrombotic regimen. Left ventricular thrombus occurred in 29% of patients receiving aspirin plus clopidogrel, compared with about 11% among those receiving aspirin, clopidogrel, and rivaroxaban. Rates were lower among patients treated with ticagrelor-based regimens, at about 7% with or without rivaroxaban.
Major adverse cardiovascular events at 1 month were uncommon and similar between groups. Death, myocardial infarction, or stroke occurred in fewer than 2% of patients in either treatment group.
Bleeding events were more frequent among patients receiving triple therapy. Any bleeding occurred in 18% of patients receiving rivaroxaban compared with 9% of those receiving dual antiplatelet therapy alone. Rates of major bleeding were low and similar between groups, but minor bleeding was more common with rivaroxaban.
The researchers noted several limitations, including the open-label design and fewer thrombus events than expected, which reduced the statistical power of the trial. As a result, the findings should be interpreted cautiously because a modest treatment effect cannot be excluded.
APERITIF was funded by a grant from the Programme Hospitalier de Recherche Clinique issued by the French Ministry of Health. The study was sponsored by Assistance Publique–Hôpitaux de Paris with an unrestricted grant from Bayer. Several researchers reported consulting fees or other financial relationships with pharmaceutical companies.
Source: JAMA Cardiology
