METHODS: From 31 July 2017 to 1 October 2021, patients aged ≥60 years undergoing elective non-cardiac surgery were randomly assigned to either discontinue or continue RAS inhibitors prescribed for existing medical conditions in six UK centres. Renin-angiotensin system inhibitors were withheld for different durations (2-3 days) before surgery, according to their pharmacokinetic profile. The primary outcome, masked to investigators, clinicians, and patients, was myocardial injury [plasma high-sensitivity troponin-T (hs-TnT) ≥ 15 ng/L within 48 h after surgery, or ≥5 ng/L increase when pre-operative hs-TnT ≥15 ng/L]. Pre-specified adverse haemodynamic events occurring within 48 h of surgery included acute hypertension (>180 mmHg) and hypotension requiring vasoactive therapy.
RESULTS: Two hundred and sixty-two participants were randomized to continue (n = 132) or stop (n = 130) RAS inhibitors. Myocardial injury occurred in 58 (48.3%) patients randomized to discontinue, compared with 50 (41.3%) patients who continued, RAS inhibitors [odds ratio (for continuing): 0.77; 95% confidence interval (CI) 0.45-1.31]. Hypertensive adverse events were more frequent when RAS inhibitors were stopped [16 (12.4%)], compared with 7 (5.3%) who continued RAS inhibitors [odds ratio (for continuing): 0.4; 95% CI 0.16-1.00]. Hypotension rates were similar when RAS inhibitors were stopped [12 (9.3%)] or continued [11 (8.4%)].
CONCLUSIONS: Discontinuing RAS inhibitors before non-cardiac surgery did not reduce myocardial injury, and could increase the risk of clinically significant acute hypertension. These findings require confirmation in future studies.
方法:从2017年7月31日至2021年10月1日,60岁以上接受非心脏择期手术的患者被随机分配停止或继续在英国六个中心针对现有医疗条件开出的RAS抑制剂。肾素-血管紧张素系统抑制剂在手术前停用不同持续时间(2-3天),根据他们的药代动力学特征。主要结果,给调查人员蒙面,临床医生,和病人,心肌损伤[术后48小时内血浆高敏肌钙蛋白T(hs-TnT)≥15ng/L,或术前hs-TnT≥15ng/L时增加≥5ng/L]。在手术后48小时内发生的预先指定的不良血流动力学事件包括急性高血压(>180mmHg)和需要血管活性治疗的低血压。
结果:两百六十二名参与者被随机分配继续(n=132)或停止(n=130)RAS抑制剂。58例(48.3%)随机停药的患者发生了心肌损伤,与50名(41.3%)继续治疗的患者相比,RAS抑制剂[优势比(持续):0.77;95%置信区间(CI)0.45-1.31]。停用RAS抑制剂后,高血压不良事件更频繁[16(12.4%)],与7名(5.3%)继续使用RAS抑制剂的患者相比[比值比(持续):0.4;95%CI0.16-1.00].停用RAS抑制剂[12(9.3%)]或继续使用[11(8.4%)]时低血压率相似。
结论:非心脏手术前停用RAS抑制剂并不能减轻心肌损伤,并可能增加临床上显著的急性高血压的风险。这些发现需要在未来的研究中得到证实。