Ischemic/bleeding event after short dual-antiplatelet therapy in patients with high bleeding risk: Sub-analysis of the MODEL U-SES study

Abstract

Background: This analysis aimed to evaluate the clinical impact of high bleeding risk (HBR) on adverse events after percutaneous coronary intervention (PCI). Methods:We retrospectively analyzed 1695 patients in the MODEL U-SES study, which was a multicenter, open-label, prospective observational study evaluating safety of 3-month dual antiplatelet therapy (DAPT) after Ultimaster stent (Terumo Corporation, Tokyo, Japan) implantation at 65 sites in Japan. Patients were divided into 2 groups (HBR/Non-HBR) according to modified Academic Research Consortium-HBR criteria. Ischemic/thrombotic event (cardiovascular death, myocardial infarction, ischemic stroke, and stent thrombosis) and bleeding event (Bleeding Academic Research Consortium 3 or 5) at 1 year were evaluated.Results: Of 1695 patients, 840 patients were categorized as HBR and 855 patients were Non-HBR. Oneyear follow-up was completed in 95.3%. During 1-year follow-up, ischemic/thrombotic events were observed in 31 cases (1.8%) and bleeding events occurred in 21 cases (1.2%). Presence of HBR was significantly associated with higher incidence of ischemic/thrombotic events as compared to Non-HBR (adjusted hazard ratio, 0.16; 95% confidence interval, 0.05 to 0.50), whereas the incidence of bleeding events did not reach statistical significance between HBR and Non-HBR. In comparison of monotherapy after DAPT, P2Y 12 inhibitor monotherapy after DAPT had comparable ischemic/thrombotic and bleeding events with aspirin monotherapy after DAPT in both HBR and Non-HBR. Conclusion:In contemporary PCI practice, nearly half of patients had HBR and presence of HBR significantly increased risk of ischemic/thrombotic events. Both aspirin and P2Y 12 inhibitor monotherapy following short DAPT had low and comparable ischemic/bleeding events.

Comparison of original and modified Academic Research Consortium for High Bleeding Risk definitions in real-world practice

“…Since major bleeding events seem to increase over time as shown in a previous report and our data [11], we believe that all three definitions are equally useful in distinguishing a high bleeding population through long-term periods. While not only bleeding but also ischemic events are related to post-PCI mortality, the diagnostic value for long-term ischemic events in each definition was similar [24][25][26]. We found that each definition could be used similarly for predicting major bleeding and ischemic events.…”