Total Thrombus-Formation Analysis System can Predict 1-Year Bleeding Events in Patients with Coronary Artery Disease

Aims: The assessment of bleeding risk in patients with coronary artery disease (CAD) is clinically important. We recently developed the Total Thrombus-Formation Analysis System (T-TAS) for the quantitative analysis of thrombus formation using microchips with thrombogenic surfaces. Here, we assessed the utility of T-TAS parameters in predicting 1-year bleeding events in patients with CAD. Methods: The study subjects were 561 consecutive patients who underwent coronary angiography (CAG) between August 2013 and September 2016 for suspected CAD. Blood samples collected at the time of CAG were used for T-TAS to compute the area under the curve (AUC) (AR(10)-AUC(30)) in the AR chip. Patients were divided into three groups according to AR(10)-AUC(30) (low: ≤ 1603, intermediate, and high: > 1765, n = 187 each). One-year bleeding events were defined by the Platelet Inhibition and Patient Outcomes criteria. Results: Bleeding occurred in 21 (3.7%) patients and was classified as major (8 [1.4%]) and minor (13 [2.3%]). The AR(10)-AUC(30) levels were significantly lower in the bleeding group than the non-bleeding group (median [interquartile range] 1590 [1442–1734] vs. 1687 [1546–1797], p = 0.04). Univariate Cox regression analysis demonstrated that low AR(10)-AUC(30), high prothrombin time-international normalized ratio levels, and diabetes correlated with bleeding events. Multivariate Cox regression analysis identified low AR(10)-AUC(30) levels as a significant determinant of bleeding events. Kaplan-Meier survival curves showed a higher rate of bleeding events in the low than the high AR(10)-AUC(30) group (p = 0.007). Conclusions: The results highlight the potential usefulness of the AR(10)-AUC(30) levels in the prediction of 1-year bleeding events in patients with CAD treated with various antithrombotic therapies.