Dobies David R, Barber Kimberly R, Cohoon Amanda L
Department of Cardiology , Regional Cardiology Associates , Grand Blanc, Michigan , USA.
Clinical Research, Genesys Regional Medical Center, Office of Research , Grand Blanc, Michigan , USA.
Open Heart. 2014 Aug 12;1(1):e000087. doi: 10.1136/openhrt-2014-000087. eCollection 2014.
Studies have demonstrated bivalirudin efficacy in some patients at increased risk of bleeding. The aim of this study was to determine the extent to which bleeding reduction is achieved among all patients using bivalirudin as compared with a heparin with or without 2B3A inhibitor strategy.
This is a real-world, large-scale retrospective study utilising the American College of Cardiology (ACC) data from a 37-hospital Ascension Health System. The registry represents routine clinical practice between 1 June 2009 and 30 June 2012. End points included major bleeding, major adverse cardiac events and death. Multivariate regression analysis modelled on predictors of end points.
This study included 58 862 PCI procedures. Major bleeding rates were lowest for bivalirudin plus closure device overall (OR=0.53, CI 0.21 to 0.84, p=0.001). The use of a device for access closure contributed to the greatest declines in major bleeding. Compared with heparin with device, bivalirudin with device had a significantly lower rate of bleeding (OR=0.37, CI 0.18 to 0.74, p=0.005). The use of device had a greater effect on decreasing bleeding among patients receiving bivalirudin compared with heparin, especially among women (p=0.001). After adjustment for 2B3A use, this advantage was no longer significant in ST segment elevation myocardial infarction patients (OR=1.8, CI 0.5 to 6.0, p=0.34).
All risk groups in this real world database representing current clinical practice benefited from the use of bivalirudin and device closure with lower risk groups benefiting the most. This robust analysis of real-world clinical data supports a combined treatment strategy of bivalirudin and closure device.
研究已证明比伐卢定在一些出血风险增加的患者中具有疗效。本研究的目的是确定与使用或不使用2B3A抑制剂策略的肝素相比，在所有使用比伐卢定的患者中减少出血的程度。
这是一项利用美国心脏病学会（ACC）来自一个拥有37家医院的阿森松医疗系统数据的真实世界、大规模回顾性研究。该登记处代表了2009年6月1日至2012年6月30日期间的常规临床实践。终点包括大出血、主要不良心脏事件和死亡。基于终点预测因素进行多变量回归分析。
本研究包括58862例经皮冠状动脉介入治疗（PCI）手术。总体而言，比伐卢定加闭合装置的大出血率最低（比值比[OR]=0.53，可信区间[CI]0.21至0.84，p=0.001）。使用闭合装置对大出血的下降贡献最大。与使用装置的肝素相比，使用装置的比伐卢定出血率显著更低（OR=0.37，CI 0.18至0.74，p=0.005）。与肝素相比，使用装置对接受比伐卢定的患者减少出血的效果更大，尤其是在女性中（p=0.001）。在调整2B3A的使用后，这一优势在ST段抬高型心肌梗死患者中不再显著（OR=1.8，CI 0.5至6.0，p=0.34）。
在这个代表当前临床实践的真实世界数据库中，所有风险组都从使用比伐卢定和装置闭合中获益，低风险组获益最大。对真实世界临床数据的这一有力分析支持比伐卢定和闭合装置的联合治疗策略。
