Development and assessment of total thrombus-formation analysis system-based bleeding risk model in patients undergoing percutaneous coronary intervention

BACKGROUND Antithrombotic therapy is established for the treatment of various cardiovascular events. However, it has been shown to increase the bleeding risk. Total Thrombus-formation Analysis System (T-TAS) is reported to be useful for evaluating thrombogenicity. Here, we estimated whether T-TAS is useful for predicting bleeding events risk in patients undergoing percutaneous coronary intervention (PCI). METHODS This was a retrospective, observational study at Kumamoto University Hospital between April 2017 and March 2019. Blood samples obtained on the day of PCI were used in T-TAS to compute the thrombus formation area under the curve (AUC) (AR10-AUC30, AUC for AR chip). We divided the study population into 2 groups according to the Academic Research Consortium for High Bleeding Risk (ARC-HBR) (182 patients in ARC-HBR positive, 118 in ARC-HBR negative). The primary endpoint was 1-year bleeding events that were defined by Bleeding Academic Research Consortium type2, 3, or 5. RESULTS The AR10-AUC30 levels were significantly lower in the ARC-HBR positive group than in the ARC-HBR negative group (median [interquartile range] 1568.1 [1258.5-1744.1] vs. 1723.1 [1567.0-1799.5], p < 0.001). The combination of ARC-HBR and AR10-AUC30 could discriminate the bleeding risk, and improved predictive capacity compared with ARC-HBR by c-statistics. Decision-curve analysis also revealed that combining AR10-AUC30 with ARC-HBR ameliorated bleeding risk-prediction. In multivariate Cox hazards analyses, combining ARC-HBR with lower AR10-AUC30 levels was significantly associated with 1-year bleeding events. CONCLUSIONS The results highlight that AR10-AUC30 evaluated by T-TAS could be a potentially useful marker for predicting high bleeding risk in patients undergoing PCI.