Roshanov Pavel S, Walsh Michael, Devereaux P J, MacNeil S Danielle, Lam Ngan N, Hildebrand Ainslie M, Acedillo Rey R, Mrkobrada Marko, Chow Clara K, Lee Vincent W, Thabane Lehana, Garg Amit X
Lilibeth Caberto Kidney Clinical Research Unit, London Health Sciences Centre, London, Ontario, Canada.
Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, Ontario, Canada.
BMJ Open. 2017 Jan 9;7(1):e013510. doi: 10.1136/bmjopen-2016-013510.
The Revised Cardiac Risk Index (RCRI) is a popular classification system to estimate patients' risk of postoperative cardiac complications based on preoperative risk factors. Renal impairment, defined as serum creatinine >2.0 mg/dL (177 µmol/L), is a component of the RCRI. The estimated glomerular filtration rate has become accepted as a more accurate indicator of renal function. We will externally validate the RCRI in a modern cohort of patients undergoing non-cardiac surgery and update its renal component.
The Vascular Events in Non-cardiac Surgery Patients Cohort Evaluation (VISION) study is an international prospective cohort study. In this prespecified secondary analysis of VISION, we will test the risk estimation performance of the RCRI in ∼34 000 participants who underwent elective non-cardiac surgery between 2007 and 2013 from 29 hospitals in 15 countries. Using data from the first 20 000 eligible participants (the derivation set), we will derive an optimal threshold for dichotomising preoperative renal function quantified using the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) glomerular filtration rate estimating equation in a manner that preserves the original structure of the RCRI. We will also develop a continuous risk estimating equation integrating age and CKD-Epi with existing RCRI risk factors. In the remaining (approximately) 14 000 participants, we will compare the risk estimation for cardiac complications of the original RCRI to this modified version. Cardiac complications will include 30-day non-fatal myocardial infarction, non-fatal cardiac arrest and death due to cardiac causes. We have examined an early sample to estimate the number of events and the distribution of predictors and missing data, but have not seen the validation data at the time of writing.
The research ethics board at each site approved the VISION protocol prior to recruitment. We will publish our results and make our models available online at http://www.perioperativerisk.com.
ClinicalTrials.gov NCT00512109.
修订后的心脏风险指数（RCRI）是一种常用的分类系统，用于根据术前危险因素评估患者术后心脏并发症的风险。肾功能损害定义为血清肌酐>2.0 mg/dL（177 µmol/L），是RCRI的一个组成部分。估计肾小球滤过率已被公认为更准确的肾功能指标。我们将在接受非心脏手术的现代患者队列中对RCRI进行外部验证，并更新其肾脏部分。
非心脏手术患者队列评估中的血管事件（VISION）研究是一项国际前瞻性队列研究。在VISION的这项预先指定的二次分析中，我们将在来自15个国家29家医院的约34000名在2007年至2013年间接受择期非心脏手术的参与者中测试RCRI的风险估计性能。使用前20000名符合条件的参与者（推导集）的数据，我们将得出一个最佳阈值，用于对使用慢性肾脏病流行病学协作组（CKD-Epi）肾小球滤过率估计方程量化的术前肾功能进行二分法划分，同时保持RCRI的原始结构。我们还将开发一个整合年龄和CKD-Epi以及现有RCRI危险因素的连续风险估计方程。在其余（约）14000名参与者中，我们将比较原始RCRI与这个修改版本对心脏并发症的风险估计。心脏并发症将包括30天非致命性心肌梗死、非致命性心脏骤停和心脏原因导致的死亡。我们已经检查了一个早期样本以估计事件数量、预测因素分布和缺失数据，但在撰写本文时还未看到验证数据。
每个研究地点的研究伦理委员会在招募前批准了VISION方案。我们将公布我们的结果，并在http://www.perioperativerisk.com网站上提供我们的模型。
ClinicalTrials.gov NCT00512109。
