Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
JAMA. 2022 Sep 6;328(9):839-849. doi: 10.1001/jama.2022.13382.
Contrast-associated acute kidney injury (AKI) is a common complication of coronary angiography and percutaneous coronary intervention (PCI) that has been associated with high costs and adverse long-term outcomes.
To determine whether a multifaceted intervention is effective for the prevention of AKI after coronary angiography or PCI.
DESIGN, SETTING, AND PARTICIPANTS: A stepped-wedge, cluster randomized clinical trial was conducted in Alberta, Canada, that included all invasive cardiologists at 3 cardiac catheterization laboratories who were randomized to various start dates for the intervention between January 2018 and September 2019. Eligible patients were aged 18 years or older who underwent nonemergency coronary angiography, PCI, or both; who were not undergoing dialysis; and who had a predicted AKI risk of greater than 5%. Thirty-four physicians performed 7820 procedures among 7106 patients who met the inclusion criteria. Participant follow-up ended in November 2020.
During the intervention period, cardiologists received educational outreach, computerized clinical decision support on contrast volume and hemodynamic-guided intravenous fluid targets, and audit and feedback. During the control (preintervention) period, cardiologists provided usual care and did not receive the intervention.
The primary outcome was AKI. There were 12 secondary outcomes, including contrast volume, intravenous fluid administration, and major adverse cardiovascular and kidney events. The analyses were conducted using time-adjusted models.
Of the 34 participating cardiologists who were divided into 8 clusters by practice group and center, the intervention group included 31 who performed 4327 procedures among 4032 patients (mean age, 70.3 [SD, 10.7] years; 1384 were women [32.0%]) and the control group included 34 who performed 3493 procedures among 3251 patients (mean age, 70.2 [SD, 10.8] years; 1151 were women [33.0%]). The incidence of AKI was 7.2% (310 events after 4327 procedures) during the intervention period and 8.6% (299 events after 3493 procedures) during the control period (between-group difference, -2.3% [95% CI, -0.6% to -4.1%]; odds ratio [OR], 0.72 [95% CI, 0.56 to 0.93]; P = .01). Of 12 prespecified secondary outcomes, 8 showed no significant difference. The proportion of procedures in which excessive contrast volumes were used was reduced to 38.1% during the intervention period from 51.7% during the control period (between-group difference, -12.0% [95% CI, -14.4% to -9.4%]; OR, 0.77 [95% CI, 0.65 to 0.90]; P = .002). The proportion of procedures in eligible patients in whom insufficient intravenous fluid was given was reduced to 60.8% during the intervention period from 75.1% during the control period (between-group difference, -15.8% [95% CI, -19.7% to -12.0%]; OR, 0.68 [95% CI, 0.53 to 0.87]; P = .002). There were no significant between-group differences in major adverse cardiovascular events or major adverse kidney events.
Among cardiologists randomized to an intervention including clinical decision support with audit and feedback, patients undergoing coronary procedures during the intervention period were less likely to develop AKI compared with those treated during the control period, with a time-adjusted absolute risk reduction of 2.3%. Whether this intervention would show efficacy outside this study setting requires further investigation.
ClinicalTrials.gov Identifier: NCT03453996.
对比剂相关急性肾损伤(AKI)是冠状动脉造影和经皮冠状动脉介入治疗(PCI)的常见并发症,与高成本和不良长期结局相关。
确定多方面干预措施是否可有效预防冠状动脉造影或 PCI 后 AKI。
设计、设置和参与者:这是一项在加拿大艾伯塔省进行的阶梯式、聚类随机临床试验,包括所有在 3 个心脏导管实验室进行侵入性心脏病学的介入心脏病学家,他们被随机分配到干预措施的不同起始日期,时间为 2018 年 1 月至 2019 年 9 月。纳入的患者为年龄在 18 岁及以上、接受非紧急冠状动脉造影、PCI 或两者兼有的患者;未进行透析的患者;预测 AKI 风险大于 5%的患者。34 名医生在 7106 名符合纳入标准的患者中进行了 7820 例手术。参与者随访于 2020 年 11 月结束。
在干预期间,心脏病学家接受了教育外展、基于对比剂体积和血流动力学指导的静脉输液目标的计算机化临床决策支持,以及审核和反馈。在对照(干预前)期间,心脏病学家提供常规护理,并且不接受干预。
主要结局是 AKI。有 12 个次要结局,包括对比剂用量、静脉输液量和主要不良心血管和肾脏事件。分析使用时间调整模型进行。
在 34 名参与的心脏病学家中,他们按照实践小组和中心分为 8 个组,干预组包括 31 名在 4032 名患者(平均年龄 70.3[SD,10.7]岁;1384 名女性[32.0%])中进行了 4327 例手术,对照组包括 34 名在 3251 名患者(平均年龄 70.2[SD,10.8]岁;1151 名女性[33.0%])中进行了 3493 例手术。干预期间 AKI 的发生率为 7.2%(4327 例手术后发生 310 例),对照期间为 8.6%(3493 例手术后发生 299 例)(组间差异,-2.3%[95%CI,-0.6%至-4.1%];比值比[OR],0.72[95%CI,0.56 至 0.93];P=0.01)。12 个预先指定的次要结局中,有 8 个没有显著差异。在干预期间,过度使用对比剂的手术比例从对照期间的 51.7%降至 38.1%(组间差异,-12.0%[95%CI,-14.4%至-9.4%];OR,0.77[95%CI,0.65 至 0.90];P=0.002)。在符合条件的患者中,给予的静脉输液不足的手术比例从对照期间的 75.1%降至干预期间的 60.8%(组间差异,-15.8%[95%CI,-19.7%至-12.0%];OR,0.68[95%CI,0.53 至 0.87];P=0.002)。两组间主要不良心血管事件或主要不良肾脏事件无显著差异。
在随机接受包括审核和反馈的临床决策支持的心脏病学家中,与对照期间接受治疗的患者相比,接受冠状动脉手术的患者发生 AKI 的可能性更低,时间调整后绝对风险降低 2.3%。该干预措施在研究环境之外是否有效,还需要进一步研究。
ClinicalTrials.gov 标识符:NCT03453996。