Putera Martin, Roark Robin, Lopes Renato D, Udayakumar Krishna, Peterson Eric D, Califf Robert M, Shah Bimal R
Duke-National University of Singapore Graduate Medical School, Singapore.
Duke University School of Medicine, Durham, NC.
Am Heart J. 2015 Feb;169(2):266-73. doi: 10.1016/j.ahj.2014.09.015. Epub 2014 Nov 12.
The use of evidence-based therapies has improved the outcome of patients with acute coronary syndrome (ACS), but there is a time lag between the generation of clinical evidence and its application in routine clinical practice. We sought to quantify temporal lags in the lifecycle of American College of Cardiology (ACC)/American Heart Association (AHA) class IA ACS therapies.
Using current and historical ACC/AHA guideline publications, we retrieved publication dates of pivotal clinical trials (PCTs) and class IA guideline-recommended therapies for patients with ST-elevation myocardial infarction (STEMI) and unstable angina (UA)/non-STEMI (NSTEMI). Clinical practice uptake data for each therapy were retrieved from the National Registry for Myocardial Infarction, Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines, and Acute Coronary Treatment and Intervention Outcomes Network Registry-Get with the Guidelines, which are registries containing publicly available peer-reviewed data. Descriptive data were calculated and compared for each phase of the evidence lifecycle for both STEMI and UA/NSTEMI drug classifications.
We identified 11 class IA- and 4 class IB/IC-recommended therapies for acute, inhospital, and discharge use for patients with STEMI or UA/NSTEMI. The median time lags were 2 years (interquartile range [IQR], 1-4 years) from PCT to practice guideline recommendation, 14 years (IQR, 11-15 years) from guideline recommendation to 90% practice uptake, and overall, a 16-year median (IQR, 13-19 years) from PCT to 90% practice uptake.
The time of PCT publication to meaningful uptake of class IA ACS therapies into clinical practice took a median of 16 years. This significant time lag indicates systemic barriers to the translation of therapeutics into routine clinical practice.
循证疗法的应用改善了急性冠状动脉综合征(ACS)患者的治疗结果,但临床证据的产生与在常规临床实践中的应用之间存在时间差。我们试图量化美国心脏病学会(ACC)/美国心脏协会(AHA)IA类ACS疗法生命周期中的时间差。
利用当前和既往的ACC/AHA指南出版物,我们检索了关键临床试验(PCT)的发表日期以及针对ST段抬高型心肌梗死(STEMI)和不稳定型心绞痛(UA)/非ST段抬高型心肌梗死(NSTEMI)患者的IA类指南推荐疗法。每种疗法的临床实践采用数据从心肌梗死国家注册中心、能否通过早期实施ACC/AHA指南对不稳定型心绞痛患者进行快速危险分层以抑制不良结局以及急性冠状动脉治疗和干预结果网络注册中心获取,这些注册中心包含可公开获取的经同行评审的数据。针对STEMI和UA/NSTEMI药物分类的证据生命周期的每个阶段,计算并比较描述性数据。
我们确定了11种IA类以及4种IB/IC类推荐疗法,用于STEMI或UA/NSTEMI患者的急性、住院及出院治疗。从PCT到实践指南推荐的中位时间差为2年(四分位间距[IQR],1 - 4年),从指南推荐到90%实践采用的时间差为14年(IQR,11 - 15年),总体而言,从PCT到90%实践采用的中位时间为16年(IQR,13 - 19年)。
从PCT发表到IA类ACS疗法在临床实践中得到有效采用的时间中位值为16年。这一显著的时间差表明在将治疗方法转化为常规临床实践方面存在系统性障碍。