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Comparative Study
. 2020 Jun 1;5(6):685-692.
doi: 10.1001/jamacardio.2020.0652.

Off-label Use of Direct Oral Anticoagulants Compared With Warfarin for Left Ventricular Thrombi

Austin A Robinson  1 , Cory R Trankle  2 , Grayson Eubanks  3 , Christopher Schumann  1 , Paul Thompson  4 , Ryan L Wallace  2 , Shouri Gottiparthi  3 , Benjamin Ruth  1 , Christopher M Kramer  1   5 , Michael Salerno  1   5   6 , Kenneth C Bilchick  1 , Cody Deen  3 , Michael C Kontos  2 , John Dent  1
Affiliations
Comparative Study

Off-label Use of Direct Oral Anticoagulants Compared With Warfarin for Left Ventricular Thrombi

Austin A Robinson et al. JAMA Cardiol. .

Abstract

Importance: Left ventricular (LV) thrombi can arise in patients with ischemic and nonischemic cardiomyopathies. Anticoagulation is thought to reduce the risk of stroke or systemic embolism (SSE), but there are no high-quality data on the effectiveness of direct oral anticoagulants (DOACs) for this indication.

Objective: To compare the outcomes associated with DOAC use and warfarin use for the treatment of LV thrombi.

Design, setting, and participants: A cohort study was performed at 3 tertiary care academic medical centers among 514 eligible patients with echocardiographically diagnosed LV thrombi between October 1, 2013, and March 31, 2019. Follow-up was performed through the end of the study period.

Exposures: Type and duration of anticoagulant use.

Main outcomes and measures: Clinically apparent SSE.

Results: A total of 514 patients (379 men; mean [SD] age, 58.4 [14.8] years) with LV thrombi were identified, including 300 who received warfarin and 185 who received a DOAC (64 patients switched treatment between these groups). The median follow-up across the patient cohort was 351 days (interquartile range, 51-866 days). On unadjusted analysis, DOAC treatment vs warfarin use (hazard ratio [HR], 2.71; 95% CI, 1.31-5.57; P = .01) and prior SSE (HR, 2.13; 95% CI, 1.22-3.72; P = .01) were associated with SSE. On multivariable analysis, anticoagulation with DOAC vs warfarin (HR, 2.64; 95% CI, 1.28-5.43; P = .01) and prior SSE (HR, 2.07; 95% CI, 1.17-3.66; P = .01) remained significantly associated with SSE.

Conclusions and relevance: In this multicenter cohort study of anticoagulation strategies for LV thrombi, DOAC treatment was associated with a higher risk of SSE compared with warfarin use, even after adjustment for other factors. These results challenge the assumption of DOAC equivalence with warfarin for LV thrombi and highlight the need for prospective randomized clinical trials to determine the most effective treatment strategies for LV thrombi.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Robinson reported receiving grants from the National Institutes of Health during the conduct of the study. Dr Schumann reported receiving grants from the National Institutes of Health during the conduct of the study. Dr Salerno reported receiving grants from the National Institutes of Health and American Heart Association; access to research software from Siemens Healthcare; and research support for participation in the PRECISE clinical trial from Heart Flow outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Oral Anticoagulation Strategies
Of the 514 patients with left ventricular thrombi, 421 were treated with an oral anticoagulant. Three hundred were treated with warfarin at any point during the follow-up period (any warfarin) and 185 were treated with a direct oral anticoagulant (DOAC; any DOAC). These groups included a mixed cohort of 64 patients (therapy change), who switched treatment, such that there were 236 patients treated exclusively with warfarin (warfarin only), and 121 patients treated exclusively with a DOAC (DOAC only). Among the patients treated with a DOAC, 141 were treated with apixaban, 46 with rivaroxaban, and 9 with dabigatran. No patients were treated with edoxaban.
Figure 2.
Figure 2.. Survival Curves for Freedom From Stroke and Systemic Embolism
Survival curves are shown for freedom from stroke and systemic embolism (SSE) in patients with left ventricular thrombus after index echocardiogram, Mantel-Byar P < .001. DOAC indicates direct oral anticoagulant.
See this image and copyright information in PMC

Comment in

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