Key result
Rivaroxaban shows no significant benefit over warfarin for complete LVT resolution at three months.
Why the study?
The role of direct oral anticoagulants in the treatment of left ventricular thrombus after ST-elevation myocardial infarction remains uncertain.
Does rivaroxaban improve complete left ventricular thrombus resolution at 3 months compared to warfarin in patients with STEMI complicated by LVT?
RCT (n=50)
Open-label
Does rivaroxaban improve complete left ventricular thrombus resolution at 3 months compared to warfarin in patients with STEMI complicated by LVT?
Relative Risk: 1.4 (95% CI 0.91–2.15)
Absolute Event Rate: 76% vs 54.2%
p-value: p=0.12
Rivaroxaban 15 mg daily showed a non-significant trend toward improved LVT resolution at 3 months compared to warfarin in post-STEMI patients, with a favorable safety profile.
Trend toward higher LVT resolution with rivaroxaban is nonsignificant; leaves open DOAC superiority versus warfarin in post-STEMI patients.
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).
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Jenab et al. (2024) conducted an RCT in Left ventricular thrombus after ST-elevation myocardial infarction (n=50). Rivaroxaban vs. Warfarin was evaluated on Complete LVT resolution at 3 months (RR 1.40, 95% CI 0.91-2.15, p=0.12). Rivaroxaban resulted in complete left ventricular thrombus resolution at 3 months in 76.0% of patients compared to 54.2% with warfarin (RR 1.40; 95% CI 0.91-2.15; p=0.12).
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