The usefulness of the direct oral anticoagulant score for predicting bleeding risk in patients with atrial fibrillation undergoing percutaneous coronary intervention: a multicenter study

Background Major bleeding after percutaneous coronary intervention (PCI) is associated with increased mortality. Therefore, assessing major bleeding risk before the procedure is essential. According to the European Society of Cardiology guidelines, early switching to oral anticoagulant (OAC) monotherapy should be considered in high-bleeding-risk patients requiring OAC therapy and not having a high ischemic risk. However, no standardized assessment tools for predicting bleeding risk have been established in those patients. Moreover, since OAC utilization is included as a criterion for bleeding risk criteria in the Academic Research Consortium for high bleeding risk (ARC-HBR), many patients with atrial fibrillation (AF) are stratified as high-bleeding risk. This suggests that the ARC-HBR may not provide sufficient risk stratification in AF patients undergoing PCI. The Direct Oral Anticoagulant (DOAC) score was recently developed to predict bleeding events in patients with AF. However, its clinical implications in patients with AF undergoing PCI remain unclear. Purpose This study aims to evaluate the predictive value of the DOAC score for major bleeding risk in patients with AF undergoing PCI. Methods The present study was a retrospective analysis of data from the SAKURA PCI2 Antithrombotic Registry, a multicenter prospective observational study. A total of 140 patients with AF underwent PCI between June, 2020 and September, 2022 were analyzed in the present study. Based on previous reports, patients with AF were stratified into a very high-risk (VHR) group (DOAC score ≥10) or a non-very high-risk (non-VHR) group (DOAC score <10). The primary outcome was defined as major bleeding within one year. The secondary outcome was defined as all-cause mortality within one year. Results A total of 140 patients were analyzed. The mean age was 75.4 ± 9.6 years old, and the prevalence of high-bleeding risk as defined by the ARC-HBR was 94.2%. Among the study participants, 53(37.9%) were assigned to a VHR group and 87(62.1%) to a non-VHR group. Patients with VHR had higher rates of one-year major bleeding than those with non-VHR (10.2% vs. 1.2%, log-rank p= 0.02). All-cause mortality within one year tended to be higher in patients with VHR than those with non-VHR (11.3% vs. 3.5%, log-rank p= 0.07). In the Receiver Operating Characteristic curve analysis for predicting major bleeding, the DOAC score had the largest area under the curve compared to the ARC-HBR and HAS-BLED score (0.779 vs. 0.662 vs. 0.535, p = 0.016). Conclusion Patients with AF classified as VHR were associated with one-year major bleeding. The DOAC score may be useful information for assessing major bleeding risk in patients with AF undergoing PCI and for guiding the optimal timing of switching to OAC monotherapy in clinical practice.