A randomized trial of antithrombotic therapy in patients with acute coronary syndrome and coronary ectasia.
Background: Coronary artery ectasia (CAE) of the culprit infarct artery is a rare finding in patients with acute coronary syndrome (ACS). While anticoagulants have been suggested to reduce recurrent events, the optimal antithrombotic therapy remains unclear.
Methods: OVER-TIME was an open label, exploratory, randomized controlled trial comparing dual antiplatelet therapy (DAPT; acetyl-salicylic-acid 100mg plus clopidogrel 75mg daily) versus single antiplatelet (SAPT, clopidogrel 75mg) plus DOAC (rivaroxaban 15mg) in patients with ACS and CAE. The study primary objectives were 1) the composite of cardiovascular death, recurrent MI and repeat revascularization and 2) total bleeding events (BARC 1-5) at 12 months. The secondary objective was fibrin clot lysis time (using turbidimetry).
Results: A total of 62 patients were randomized, 32 (51.6%) to receive DAPT and 30 (48.3%) to receive SAPT+DOAC. Patients were aged 55.5 years (±10.6) and mostly male (86.9%); STEMI was the most common presentation (83.8%). No statistically significant differences (HR 0.24, 95% CI 0.02-2.16, P = .20) in the risk of the primary endpoint were found; however, a numerically lower rate of recurrent MI (4 events - 12.5% - in the DAPT arm vs. 1 event - 3.3% in the SAPT+DOAC arm) was observed. The risk of bleeding events was not different HR 0.75 (95% CI 0.26-2.16, P = .59). A statistically significant reduction in fibrin clot lysis time (-24.7% reduction, P = .038) was observed in those randomized to SAPT+DOAC, but not in DAPT (-14.7% reduction, P = .25).
Conclusions: In this exploratory study including patients with ACS and CAE of the culprit artery, the use of rivaroxaban 15mg in addition to clopidogrel was not associated with a statistically lower risk of major adverse cardiovascular events; however, a lower rate of recurrent MI and a reduction in fibrin clot lysis time were observed. Future studies to address antithrombotic therapy in CAE are needed. Background: ClinicalTrials.gov ID NCT05233124, URL: https://clinicaltrials.gov/study/NCT05233124.