The usefulness of total thrombus-formation analysis system for predicting high bleeding risk in coronary artery disease patients taking anticoagulants who underwent percutaneous coronary intervention
Abstract Background Although anticoagulants are widely used for prevention of cerebral infarction in patients with atrial fibrillation (AF), venous thrombosis, and valvular disease, it is possible that anticoagulants increase bleeding events in daily medical practices. Recently, we reported that the total thrombus-formation analysis system (T-TAS) was useful for evaluating bleeding risk in coronary artery disease (CAD) patients. Aim We examined whether T-TAS was practical for predicting bleeding risk in CAD patients taking anticoagulants who underwent percutaneous coronary intervention (PCI). Methods This study was the retrospective analysis of the 500 consecutive CAD patients who underwent PCI. 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 total number of study patients into two groups according to the presence of anticoagulants; 53 CAD patients with triple therapy (TT) and 447 CAD patients with dual antiplatelet therapy (DAPT). We compared clinical characteristics and prognosis between the two groups. The primary endpoint was 1-year bleeding events that were defined by ISTH bleeding criteria. We excluded the CAD patients who underwent emergency PCI, and who were treated for hemodialysis. Results All patients took aspirin and clopidogrel, or aspirin and prasugrel at baseline. Compared to the patients with DAPT, the patients with TT had atrial fibrillation and history of stroke. The AR10-AUC30 levels were significantly lower in the patients with TT than the patients with DAPT (median [interquartile range] 1402.6 [1095.1–1609.8] vs. 1679.8 [1526.4–1783.3], p<0.001). Thirty-five patients (7%) had bleeding events during follow-up [11 cases (20.8%) in the patients with TT, 24 cases (5.4%) in the patients with DAPT]. Kaplan-Meier curve analysis showed a worse 1-year bleeding event-free survival rate in the patients with TT compared with the patients with DAPT (p<0.001). Receiver operating characteristic analysis showed that AR10-AUC30 levels significantly predicted bleeding events (AUC 0.653, 95% CI 0.555–0.751; p=0.003) and the cut-off point was 1586.4 by Youden index in the present study. In multivariate Cox hazards analysis, low AR10-AUC30 level (≤1586.4) (hazard ratio 2.99; 95% CI 1.46–6.11; p=0.003) and taking warfarin (hazard ratio 3.02; 95% CI 1.24–7.34; p=0.015) were significant predictors for 1-year bleeding events. Conclusions The present findings suggested that the AR10-AUC30 level determined by T-TAS could be a useful marker for predicting high bleeding risk in CAD patients taking anticoagulants who underwent PCI. Funding Acknowledgement Type of funding source: None
