背景:尽管缺乏科学证据,但目前仍建议在冠状动脉手术前禁食以减少并发症。
目的:TONIC(冠状动脉介入治疗前禁食和不禁食对不良事件发生的比较)非劣效性试验研究了冠状动脉手术前非禁食策略(随意进食食物和饮料)与传统禁食(固体食物和液体>6小时)的安全性和舒适性。
方法:在这个单中心,prospective,单盲随机对照试验,纳入739例接受冠状动脉手术的患者,并随机分配至禁食或非禁食策略。紧急程序被排除在外。主要终点是血管迷走反应,低血糖(定义为血糖≤0.7g/L),和孤立的恶心和/或呕吐。非劣效性边缘为4%。次要终点是造影剂肾病和患者满意度。
结果:在739个程序(697个选修程序和42个半紧急程序)中,517例血管造影,我们进行了222例血管成形术(包括复杂和高风险手术).主要终点发生在365名非空腹患者中的30名(8.2%)与374名空腹患者中的37名(9.9%),证明非劣效性(绝对组间差异,-1.7%;单侧95%CI上限:1.8%)。无食品相关不良事件发生,两组间与对比相关的急性肾损伤相似.总的来说,两组的手术满意度和感知疼痛相似,但非禁食患者报告较少饥饿和口渴(P<0.01)。在重做冠状动脉手术的情况下,大多数患者(79%)会选择非禁食策略.
结论:TONIC随机试验证明了非禁食策略在冠状动脉手术安全性方面的非劣效性,同时提高患者的舒适度。
BACKGROUND: Fasting before coronary procedures is currently recommended to reduce complications despite the lack of scientific evidence.
OBJECTIVE: The TONIC (Comparison Between Fasting and No Fasting Before Interventional Coronary Intervention on the Occurrence of Adverse Events) noninferiority trial investigated the safety and comfort of a nonfasting strategy (ad libitum food and drinks) vs traditional fasting (>6 hours for solid food and liquids) before coronary procedures.
METHODS: In this monocentric, prospective, single-blind randomized controlled trial, 739 patients undergoing coronary procedures were included and randomized to a fasting or a nonfasting strategy. Emergency procedures were excluded. The primary endpoint was a composite of vasovagal reaction, hypoglycemia (defined by blood sugar ≤0.7 g/L), and isolated nausea and/or vomiting. Noninferiority margin was 4%. Secondary endpoints were contrast-induced nephropathy and patients\' satisfaction.
RESULTS: Among the 739 procedures (697 elective and 42 semiurgent), 517 angiographies, and 222 angioplasties (including complex and high-risk procedures) were performed. The primary endpoint occurred in 30 of 365 nonfasting patients (8.2%) vs 37 of 374 fasting patients (9.9%), demonstrating noninferiority (absolute between-group difference, -1.7%; 1-sided 95% CI upper limit: 1.8%). No food-related adverse event occurred, and contrast-related acute kidney injuries were similar between groups. Overall, procedure satisfaction and perceived pain were similar in both groups, but nonfasting patients reported less hunger and thirst (P < 0.01). In case of redo coronary procedures, most patients (79%) would choose a nonfasting strategy.
CONCLUSIONS: The TONIC randomized trial demonstrates the noninferiority of a nonfasting strategy to the usual fasting strategy for coronary procedures regarding safety, while improving patients\' comfort.