Ross Elsie Gyang, Shah Nigam, Leeper Nicholas
Division of Vascular Surgery, Stanford University Hospital and Clinics, Stanford, CA, United States of America.
Stanford Center for Biomedical Informatics Research, Stanford, CA, United States of America.
PLoS One. 2016 May 26;11(5):e0154952. doi: 10.1371/journal.pone.0154952. eCollection 2016.
The recently updated American College of Cardiology/American Heart Association cholesterol treatment guidelines outline a paradigm shift in the approach to cardiovascular risk reduction. One major change included a recommendation that practitioners prescribe fixed dose statin regimens rather than focus on specific LDL targets. The goal of this study was to determine whether achieved LDL or statin intensity was more strongly associated with major adverse cardiac events (MACE) using practice-based data from electronic health records (EHR).
We analyzed the EHR data of more than 40,000 adult patients on statin therapy between 1995 and 2013. Demographic and clinical variables were extracted from coded data and unstructured clinical text. To account for treatment selection bias we performed propensity score stratification as well as 1:1 propensity score matched analyses. Conditional Cox proportional hazards modeling was used to identify variables associated with MACE.
We identified 7,373 adults with complete data whose cholesterol appeared to be actively managed. In a stratified propensity score analysis of the entire cohort over 3.3 years of follow-up, achieved LDL was a significant predictor of MACE outcome (Hazard Ratio 1.1; 95% confidence interval, 1.05-1.2; P < 0.0004), while statin intensity was not. In a 1:1 propensity score matched analysis performed to more aggressively control for covariate balance between treatment groups, achieved LDL remained significantly associated with MACE (HR 1.3; 95% CI, 1.03-1.7; P = 0.03) while treatment intensity again was not a significant predictor.
Using EHR data we found that on-treatment achieved LDL level was a significant predictor of MACE. Statin intensity alone was not associated with outcomes. These findings imply that despite recent guidelines, achieved LDL levels are clinically important and LDL titration strategies warrant further investigation in clinical trials.
最近更新的美国心脏病学会/美国心脏协会胆固醇治疗指南概述了心血管风险降低方法的范式转变。其中一项主要变化是建议从业者开具固定剂量的他汀类药物治疗方案，而不是专注于特定的低密度脂蛋白（LDL）目标。本研究的目的是利用电子健康记录（EHR）中的基于实践的数据，确定达到的LDL水平或他汀类药物强度与主要不良心脏事件（MACE）之间的关联是否更强。
我们分析了1995年至2013年间40000多名接受他汀类药物治疗的成年患者的EHR数据。人口统计学和临床变量从编码数据和非结构化临床文本中提取。为了考虑治疗选择偏倚，我们进行了倾向评分分层以及1:1倾向评分匹配分析。使用条件Cox比例风险模型来识别与MACE相关的变量。
我们确定了7373名有完整数据且胆固醇似乎得到积极管理的成年人。在对整个队列进行的3.3年随访的分层倾向评分分析中，达到的LDL是MACE结局的显著预测因素（风险比1.1；95%置信区间，1.05 - 1.2；P < 0.0004），而他汀类药物强度不是。在为更积极地控制治疗组之间的协变量平衡而进行的1:1倾向评分匹配分析中，达到的LDL仍然与MACE显著相关（HR 1.3；95% CI，1.03 - 1.7；P = 0.03），而治疗强度再次不是显著预测因素。
利用EHR数据，我们发现治疗期间达到的LDL水平是MACE的显著预测因素。单独的他汀类药物强度与结局无关。这些发现表明，尽管有最近的指南，但达到的LDL水平在临床上很重要，LDL滴定策略值得在临床试验中进一步研究。
