Bleeding avoidance strategies and percutaneous coronary intervention outcomes: A 10-year observation from a Japanese Multicenter Registry
Bleeding avoidance strategies and percutaneous coronary intervention outcomes: A 10-year observation from a Japanese Multicenter Registry
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DOI：
10.1016/j.ahj.2021.01.010
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发表时间：
2021-03-05
影响因子：
4.8
通讯作者：
Kohsaka, Shun
中科院分区：
文献类型：
--
作者：
Sawano, Mitsuaki;Spertus, John A.;Kohsaka, Shun
背景由于出血并发症，越来越多的患者接受经皮冠状动脉介入治疗（PCI），采用避免出血策略（BAS）。然而，其与西方国家以外出血事件的相关性仍不清楚。在与国家心血管数据登记处（NCDR）CathPCI注册合作，我们的目的是评估的时间趋势和影响BAS利用日本patients.Methods我们的研究包括19,656连续PCI患者注册超过10年。这些患者分为4个时间范围组（T1：2008-2011，T2：2012-2013，T3：2014-2015和T4：2016-2018）。BAS定义为经桡动脉入路或经股动脉入路（TFA）后使用血管闭合装置（VCD）。评价了NCDR CathPCI出血模型的模型性能。通过多层次混合效应多变量logistic回归分析估计与BAS采用相关的出血减少程度。结果NCDR CathPCI出血风险评分在日本人群中表现出良好的区分度（C-统计量0.79-0.81）。BAS采用率从43%（T1）增加到91%（T4），而粗CathPCI定义的出血率从10%（T1）下降到7%（T4）。出血事件的校正比值比为0.25（95%置信区间，0.14 ± 0.45，P< .001），T4和0.26（95%置信区间0.20-0.35，P<0.001），但不影响正常工作。T4经桡动脉入路与T1接受无VCD的TFA的患者相比。结论在研究的时间范围内，日本人的出血并发症风险较低。尽管如此，观察到的出血率仍高于美国人群。
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, 0.140.45, 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.