TY - JOUR
T1 - 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
AU - Jenab, Yaser
AU - Sadeghipour, Parham
AU - Mohseni-Badalabadi, Reza
AU - Kaviani, Raheleh
AU - Hosseini, Kaveh
AU - Pasebani, Yeganeh
AU - Khederlou, Hamid
AU - Rafati, Ali
AU - Mohammadi, Zohre
AU - Jamalkhani, Sepehr
AU - Talasaz, Azita Haj Hossein
AU - Firouzi, Ata
AU - Ariannejad, Hamid
AU - Alemzadeh-Ansari, Mohammad Javad
AU - Ahmadi-Renani, Sajjad
AU - Maadani, Mohsen
AU - Farrashi, Melody
AU - Bakhshandeh, Hooman
AU - Piazza, Gregory
AU - Krumholz, Harlan M.
AU - Mehran, Roxana
AU - Lip, Gregory Y. H.
AU - Bikdeli, Behnood
PY - 2025/1/6
Y1 - 2025/1/6
N2 - 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).
AB - 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).
KW - Adult
KW - Aged
KW - Female
KW - Humans
KW - Male
KW - Middle Aged
KW - Administration, Oral
KW - Anticoagulants/therapeutic use
KW - Factor Xa Inhibitors/therapeutic use
KW - Heart Ventricles/diagnostic imaging
KW - Hemorrhage/chemically induced
KW - Pilot Projects
KW - Prospective Studies
KW - Randomized Controlled Trials as Topic
KW - Rivaroxaban/therapeutic use
KW - ST Elevation Myocardial Infarction/complications
KW - Thrombosis/drug therapy
KW - Treatment Outcome
KW - Warfarin/therapeutic use
U2 - 10.4244/EIJ-D-24-00527
DO - 10.4244/EIJ-D-24-00527
M3 - Journal article
C2 - 39773831
SN - 1774-024X
VL - 21
SP - 82
EP - 92
JO - EuroIntervention
JF - EuroIntervention
IS - 1
ER -