Direct oral anticoagulants or warfarin in patients with left ventricular thrombus after ST-elevation myocardial infarction: a pilot trial and a prespecified meta-analysis of randomised trials
Yaser Jenab, Parham Sadeghipour, Reza Mohseni‐Badalabadi, Raheleh Kaviani, Kaveh Hosseini, Yeganeh Pasebani, Hamid Khederlou, Ali Rafati, Zohre Mohammadi, Sepehr Jamalkhani, Azita H. Talasaz, Ata Firouzi, Hamid Ariannejad, Mohammad Javad Alemzadeh‐Ansari, Sajjad Ahmadi‐Renani, Mohsen Maadani, Melody Farrashi, Hooman Bakhshandeh, Gregory Piazza, Harlan M. Krumholz, Roxana Mehran, Gregory Y.H. Lip, Behnood Bikdeli
Abstract
BACKGROUND: The role of direct oral anticoagulants (DOACs) in the treatment of left ventricular thrombus (LVT) after ST-elevation myocardial infarction (STEMI) remains uncertain. AIMS: We aimed to compare the effect of rivaroxaban versus warfarin in patients with STEMI complicated by LVT. METHODS: Adult patients with STEMI and two-dimensional transthoracic echocardiography showing LVT were assigned to rivaroxaban (15 mg once daily) or warfarin (international normalised ratio goal of 2.0-2.5) in an open-label, randomised clinical trial (RCT). A prospective pooled analysis was planned comparing DOAC- versus warfarin-based anticoagulation for the same indication. The main outcome of the RCT was complete LVT resolution at 3 months, determined by a blinded imaging core laboratory. Complete LVT resolution and bleeding were investigated in the pooled analysis. RESULTS: A total of 50 patients (median age: 55 years, 18% females) were enrolled from June 2020 to November 2022. Three-month complete LVT resolution occurred in 19/25 (76.0%) patients assigned to rivaroxaban and 13/24 (54.2%) assigned to warfarin (relative risk [RR] 1.40, 95% confidence interval [CI]: 0.91-2.15; p=0.12) with no thrombotic or major bleeding events. Pooled analysis showed numerically better complete LVT resolution with DOACs (rivaroxaban and apixaban; 93/115 [80.8%] vs 79/112 [70.5%], RR 1.14, 95% CI: 0.98-1.32; p=0.08) and less major bleeding (2/116 [1.7%] and 9/112 [8.0%], risk difference -0.06, 95% CI: -0.12 to 0.00; p=0.05) than with warfarin. CONCLUSIONS: Although the findings are limited by a small sample size, the results suggest that DOACs are safe with at least similar outcomes concerning LVT resolution and major bleeding compared with warfarin. (ClinicalTrials.gov: NCT05705089).