Treatment of left ventricular thrombi with DOACS may increase stroke risk

Researchers have found in an observational study that off-label use for treatment of left ventricular thrombi with DOACs may be dangerous for patients.The treatment with DOACS was associated with an increased risk of stroke or systemic embolism compared with warfarin.Therefore off-label use of direct oral anticoagulants for left ventricular thrombi should be undertaken with caution until clinical trial data are available to compare their use with warfarin. The findings of the research have been published in JAMA Cardiology.

Lately use of anticoagulants (DOACs) in cardiovascular medicine has increased significantly.

The researchers conducted the study to ascertain whether DOACs could be used as a safe and effective treatment for left ventricular thrombi.

The current analysis was conducted as part of the Retrospective Evaluation of DOACs and Vascular Endpoints of Left Ventricular Thrombi (RED VELVT) study. Using warfarin as the reference, this portion of RED VELVT included 514 patients with left ventricular thrombi enrolled at 3 tertiary care academic medical centers between October 1, 2013 and March 31, 2019.

Of the 514 patients included in the study, the mean age was 58.4 (14.8) years, 379 were men, and the median follow-up time was 351 days. Investigators pointed out 185 patients received a DOAC, 300 patients received warfarin, and 64 patients switched treatment between the 2 groups.

Oot of all subjects, 141 patients receiving DOACs were treated with apixaban, 46 were treated with rivaroxaban, and 9 were treated with dabigatran.

The primary outcome of the study was a composite of clinically documented stroke or systemic embolism.

During the follow-up period, a total of 54 stroke or systemic embolism events occurred. Out of these, 36 were identified as ischemic strokes and 18 as systemic emboli.

In 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.

The researchers concluded that

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.

Therefore patients should be made aware that DOACs are not US Food and Drug Administration–approved for left ventricular thrombi and clinicians should be cautious in prescribing DOACs for off-label indications.

For further reference log on to:

"Off-label Use of Direct Oral Anticoagulants Compared With Warfarin for Left Ventricular Thrombi," was published in JAMA Cardiology.