LVEDP是一项非常直接的检测指标,每一常规心导管检查中均可检测。本试验中我们采用了临床实践中最常用的方式,即在左心室中置入猪尾导管,按照标准方法测量压力。这种测量值被用来指导根据LVEDP分组的患者水化治疗的级别。这些指标可有效识别出对更高容量水化产生良好疗效的患者。同时,还可识别出对中度水化治疗获益的患者。
International Circulation: Could you review the highlights of the trial? What did you find was the major difference between the LVEDP-guided hydration and the standard hydration?
Dr. Brar: The important findings were the reduction in the incidence of contrast nephropathy by 59% with LVEDP-guided hydration. The event rate with LVEDP-guided hydration was about 6.7% compared to about 16.4 % in the control group. The corresponding relative risk was 0.41 and the difference was highly statically significant. The absolute reduction was almost 10% and the number needed to treat to prevent one contrast nephropathy event with LVEDP-guided hydration was 11 patients.
《国际循环》:您能否回顾一下这项试验的亮点?根据您的经验,LVEDP指导的水化和标准水化治疗之间的最大不同是什么?
Dr. Somjot Brar:重要的发现之一是LVEDP指导的水化治疗使对比剂肾病的发生率降低达59%。LVEDP指导水化组的事件发生率为6.7%,而对照组为16.4%。相对危险度为0.41,差异有高度统计学意义。绝对风险降低近10%,LVEDP指导的水化治疗预防1例对比剂肾病的需治疗人数为11例。
International Circulation: Do you expect immediate implantation of this measurement or do you expect any more hurdles?
Dr. Brar: I envision that this will be readily adopted by many cathlabs. There is no addition cost incurred, the hemodynamic information required to institute the protocol is routinely measured in the cardio cathlab, the differences in the event rates were very significant, the end points in the study were adjudicated and there was both oversight and auditing of the trail so the study data are good quality, and the event rate in the control group is what we would have expected based on this hydration protocol and based upon experience with prior contrast nephropathy trials. In that respect, there were no significant surprises there. The underlying philosophy is that it provides a framework for the physician in terms of how to administer more fluid. We know more fluid is more effective, we are just not sure for how much and for how long. This provides a nice framework for doing what we know works.
《国际循环》:您是否期望立即推广这一做法?
Dr. Somjot Brar:我能预见到这一做法将被许多导管室所采用。这并不额外增加费用,建立这一方案所需的血流动力学信息已成为心导管室的常规检测项目,事件率的差异非常显著,研究终点经过了严格审核和评判,证实研究数据的质量非常高;同时基于这一水化方案以及既往对比剂肾病试验的经验,对照组的事件发生率符合我们的预期。就此而言,我们并不感到特别的意外。其深层的意义在于,该研究为医生如何使用更多的液体提供了一个框架。我们知道液体越多越有效,只是不知道到底给予多少液体,持续多长时间。这为我们提供了一个很好的框架。