Bleeding avoidance strategies and percutaneous coronary intervention outcomes: A 10-year observation from a Japanese
Mitsuaki Sawano1, John A Spertus2, Frederick A Masoudi3
1Department of Cardiology, Keio University School of Medicine, Tokyo, Japan.
Insights
Bleeding avoidance strategies (BASs) significantly reduced bleeding complications in Japanese patients undergoing percutaneous coronary intervention (PCI). However, bleeding rates remained higher than in the US population.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Health Services Research
Background:
- Bleeding complications are a concern for percutaneous coronary intervention (PCI).
- The effectiveness of bleeding avoidance strategies (BASs) outside Western countries is not well-established.
- Japanese patients undergoing PCI were studied to assess BAS utilization trends and impact.
Purpose of the Study:
- To evaluate the time trend of BAS adoption in Japanese PCI patients.
- To assess the impact of BAS utilization on bleeding events in this population.
- To validate the NCDR CathPCI bleeding model in Japanese patients.
Main Methods:
- A 10-year study of 19,656 PCI patients, divided into four time frames.
- BAS defined as transradial approach or vascular closure device (VCD) use after transfemoral approach (TFA).
- Multivariable logistic regression used to estimate bleeding reduction associated with BAS adoption.
Main Results:
- BAS adoption increased from 43% to 91% over the study period.
- Crude bleeding rates decreased from 10% to 7%.
- Adjusted odds ratios for bleeding were significantly lower for BAS users (0.25-0.26) compared to TFA without VCD in the initial period.
Conclusions:
- BAS use is associated with reduced bleeding risk in Japanese PCI patients.
- The NCDR CathPCI bleeding model showed good discrimination in this population.
- Despite improvements, bleeding rates in Japan were higher than in the US.
Background:
Bleeding 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.
Methods:
Our study included 19,656 consecutive PCI patients registered over 10 years. These patients were divided into 4-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 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.
Results:
The 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 for bleeding events were 0.25 (95% confidence interval, 0.14-0.45, P< .001) for those undergoing TFA with VCD in T4 and 0.26 (95% confidence interval 0.20-0.35, P< .001) for transradial approach in T4 compared to patients that received TFA without VCD in T1.
Conclusions:
BAS 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 US population.
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