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-AUC₃₀levels were significantly lower in the ARC-HBR positive group than in the ARC-HBR negative group (median [interquartile range] 1571.4 [1277.0-1745.3] vs. 1726.2 [1567.7-1799.6], 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.