Bleeding Avoidance Strategies and Percutaneous Coronary Intervention Outcomes: A Ten-year Observation from a Japanese Multicenter Registry: Post-PCI Bleeding Avoidance and Outcomes.

Abstract

BACKGROUND\nBleeding avoidance strategies (BASs) are increasingly adopted for patients undergoing percutaneous coronary intervention (PCI) due to bleeding complications. However, their association with bleeding events outside of Western countries remains unclear. In collaboration with the National Cardiovascular Data Registry (NCDR) CathPCI registry, we aimed to assess the time trend and impact of BAS utilization among Japanese patients.\n\n\nMETHODS\nOur study included 19,656 consecutive PCI patients registered over 10 years. These patients were divided into four-time frame groups (T1: 2008-2011, T2: 2012-2013, T3: 2014-2015, and T4: 2016-2018). BAS was defined as the use of transradial approach (TRA) or vascular closure device (VCD) use after transfemoral approach (TFA). Model performance of the NCDR CathPCI bleeding model was evaluated. The degree of bleeding reduction associated with BAS adoption was estimated via multilevel mixed-effects multivariable logistic regression analysis.\n\n\nRESULTS\nThe NCDR CathPCI bleeding risk score demonstrated good discrimination in the Japanese population (C-statistics 0.79-0.81). The BAS adoption rate increased from 43% (T1) to 91% (T4), whereas the crude CathPCI-defined bleeding rate decreased from 10% (T1) to 7% (T4). Adjusted odds ratios (ORs) for bleeding events were 0.25 (95% confidence interval [CI], 0.14-0.45, p <0.001) for those undergoing TFA with VCD in T4 and 0.26 (95% CI 0.20-0.35, p <0.001) for TRA in T4 compared to patients that received TFA without VCD in T1.\n\n\nCONCLUSION\nBAS use over the studied time frames was associated with lower risk of bleeding complications among Japanese. Nonetheless, observed bleeding rates remained higher compared to the United States population.