December 15, 2015
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Novel assay shows promise in evaluating bleeding risk with new oral anticoagulants

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A novel method to evaluate clot formation and lysis activities under physiological conditions appears to be a feasible approach to assess the risk for dabigatran-related bleeding complications, according to research published in Thrombosis Journal.

Kazunori Otsui, MD, of Kobe Rosai Hospital in Kobe, Japan, and colleagues assessed whether the global thrombosis test would affect shear-induced thrombi based on occlusion time and could be useful to monitor the effects of dabigatran (Pradaxa, Boehringer Ingelheim).

“Since the [global thrombosis test] can simultaneously assess both platelet reactivity and the pro-coagulant state, this system seems to have significant potential for the assessment of ischemic risk in various [CVD] states,” the researchers wrote. “Furthermore, the [global thrombosis test] system has several advantages over previous methods.”

The researchers looked at Japanese volunteers (27 men and 23 women; mean age, 69.2 ± 1.3 years) not on antithrombotic treatment, as well as patients with nonvalvular atrial fibrillation on warfarin (27 men and 16 women; mean age, 76.5 ± 1.4 years). Patients had an average CHA2DS2-VASc score of 4.14 ± 0.21 and an average HAS-BLED score of 1.86 ± 0.16.

The investigators changed patients’ therapy from warfarin to dabigatran. They used the global thrombosis test to assess thrombotic status of patients, taking measurements 1 day before and 1 month after the switch.

A novel point-of-care assay capable of measuring the time between two consecutive blood drops in a person’s non-anticoagulated blood, the global thrombosis test evaluates time needed to form an occlusive thrombus and time needed to lyse this thrombus.

At initial reading, occlusion time was 524.9 ± 17 seconds in volunteers compared with 581.7 ± 26.3 seconds in patients on warfarin. After a month on dabigatran, patients demonstrated a prolonged occlusion time of 784.5 ± 19.3 seconds. Additionally, one patient on warfarin had occlusion time greater than 900 seconds compared with 12 patients on dabigatran.

“Further assessment of this in larger populations followed up for a longer period is necessary to better evaluate the usefulness of [occlusion times], as assessed by the [global thrombosis test] as a monitoring system to assess bleeding risk with [novel oral anticoagulants],” the researchers wrote. – by Allegra Tiver

Disclosure: The researchers report no relevant financial disclosures.