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38 A meta-analysis of randomised controlled trials comparing direct oral anticoagulants against warfarin for the treatment left ventricular thrombus

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Abstract

Background

Left ventricular thrombus (LVT) is a well-recognised complication of acute myocardial infarction(1), with warfarin being the mainstay treatment. Off-label use of direct oral anticoagulants (DOACs) are increasingly being used for LVT treatment. Previously meta-analyses comparing DOACs against warfarin for the treatment LVT have predominantly consisted of observational studies. The randomised controlled trials (RCTs) published recently included small number of patients (2–5).

Purpose

We aimed to assess the safety and efficacy of DOACs vs warfarin in the management of LVT in a meta-analysis of RCTs only.

Methods

Full text RCTs comparing the effects DOACs against warfarin were identified via a comprehensive literature search. The main endpoint of interest was LVT resolution. The secondary endpoints of interest were embolic complications, and clinically significant bleeding. Two authors identified relevant articles and extracted the data independently (SK and TJ). Any disagreements were resolved by a third author (HB). Statistical analysis was undertaken (HB) using RevMan 5.4 (Nordic Cochrane Centre). Risk ratios (RRs) with 95% confidence intervals (CI) were used as summary estimates. The pooled RR was calculated with the random-effects model using the Mantel-Haenszel method. All reported P values are two-sided, with significance set at P<0.05.

Results

Four RCTs involving 183 patients were included. In the DOAC arm, 59% were on apixaban and 41% were on rivaroxaban. At 3 months, there was no difference in the rate of LVT resolution between those in the DOAC arm and the warfarin arm [74% versus 76%, RR 0.86 (95% CI 0.35 – 2.09), I2=26%, P=0.73]. There was also no difference in the rate of LVT resolution between those in the DOAC arm and the warfarin arm [89% versus 86%, RR 1.01 (95% CI 0.88 – 1.16), I2=28%, P=0.92]. There was numerically less bleeding (2.1% versus 8.6%) and less embolic complications (1.1% versus 7.5%) in the DOAC arm when compared to the warfarin arm but they were not statistically significant.

Conclusion

DOAC resulted in similar LVT resolution at 3 and 6 months when compared to warfarin and was at least as safe. Larger RCTs powered for hard clinical outcomes are needed to evaluate whether DOAC use for LVT is associated with better net adverse clinical outcomes.

Conflict of Interest

None

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