Nijssen Estelle C, Nelemans Patty J, Rennenberg Roger J, van Ommen Vincent, Wildberger Joachim E
Department of Radiology & Nuclear Medicine, Maastricht University Medical Centre, 6202 AZ Maastricht, the Netherlands.
Department of Epidemiology, Maastricht University Medical Centre, 6202 AZ Maastricht, the Netherlands.
EClinicalMedicine. 2018 Nov 9;4-5:109-116. doi: 10.1016/j.eclinm.2018.10.007. eCollection 2018 Oct-Nov.
The aim of A MAastricht Contrast-Induced Nephropathy Guideline (AMACING) trial was to evaluate non-inferiority of no prophylaxis compared to guideline-recommended prophylaxis in preventing contrast induced nephropathy (CIN), and to explore the effect on long-term post-contrast adverse outcomes. The current paper presents the long-term results.
AMACING is a single-centre, randomised, parallel-group, open-label, phase 3, non-inferiority trial in patients with estimated glomerular filtration rate [eGFR] 30-59 mL/min/1.73 m combined with risk factors, undergoing elective procedures requiring intravenous or intra-arterial iodinated contrast material. Exclusion criteria were eGFR < 30 mL/min/1.73 m, dialysis, no referral for prophylaxis. The outcomes dialysis, mortality, and change in renal function at 1 year post-contrast were secondary outcomes of the trial. Subgroup analyses were performed based on pre-defined stratification risk factors. AMACING is registered with ClinicalTrials.gov: NCT02106234.
From 28,803 referrals, 1120 at-risk patients were identified. 660 consecutive patients agreed to participate and were randomly assigned (1:1) to no prophylaxis (n = 332) or standard prophylactic intravenous hydration (n = 328). Dialysis and mortality data were available for all patients. At 365 days post-contrast dialysis was recorded in two no prophylaxis (2/332, 0.60%), and two prophylaxis patients (2/328, 0.61%; p = 0.9909); mortality was recorded for 36/332 (10.84%) no prophylaxis, and 32/328 (9.76%) prophylaxis patients (p = 0.6490). The hazard ratio was 1.118 (no prophylaxis prophylaxis) for one-year risk of death (95% CI: 0.695 to 1.801, p = 0.6449). The differences in long-term changes in serum creatinine were small between groups, and gave no indication of a disadvantage for the no-prophylaxis group.
Assuming optimal contrast administration, not giving prophylaxis to elective patients with eGFR 30-59 mL/min/1.73 m is safe, even in the long-term.
Stichting de Weijerhorst.
马斯特里赫特对比剂诱导肾病指南（AMACING）试验的目的是评估在预防对比剂诱导肾病（CIN）方面，不进行预防与指南推荐的预防措施相比是否非劣效，并探讨其对对比剂注射后长期不良结局的影响。本文展示了长期结果。
AMACING是一项单中心、随机、平行组、开放标签的3期非劣效性试验，纳入估计肾小球滤过率（eGFR）为30 - 59 mL/min/1.73 m²且合并危险因素、接受需要静脉或动脉注射碘化对比剂的择期手术的患者。排除标准为eGFR < 30 mL/min/1.73 m²、透析、未转诊进行预防。对比剂注射后1年时的透析、死亡率和肾功能变化是该试验 的次要结局。基于预先定义的分层危险因素进行亚组分析。AMACING已在ClinicalTrials.gov注册：NCT02106234。
在28803例转诊患者中，识别出1120例有风险的患者。660例连续患者同意参与并被随机分配（1:1）至不进行预防组（n = 332）或标准预防性静脉补液组（n = 328）。所有患者均有透析和死亡率数据。对比剂注射后365天时，不进行预防组有2例患者进行了透析（2/332，0.60%），预防组有2例患者进行了透析（2/328，0.61%；p = 0.9909）；不进行预防组36/332例（10.84%）患者死亡，预防组32/328例（9.76%）患者死亡（p = 0.6490）。死亡的1年风险的风险比为1.118（不进行预防对比预防）（95% CI：0.695至1.801，p = 0.6449）。两组间血清肌酐的长期变化差异很小，未显示不进行预防组有劣势。
假设对比剂使用最佳，对于eGFR为30 - 59 mL/min/1.73 m²的择期手术患者不进行预防是安全的，即使是长期来看。
Stichting de Weijerhorst。
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