Management of Coronary Disease in Patients with Advanced Kidney Disease
Management of Coronary Disease in Patients with Advanced Kidney Disease
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DOI：
10.1056/nejmoa1915925
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发表时间：
2020-04-23
影响因子：
158.5
通讯作者：
Hochman, J. S.
中科院分区：
文献类型：
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作者：
Bangalore, S.;Maron, D. J.;Hochman, J. S.
背景：评估稳定型冠心病患者血运重建术效果的临床试验通常排除了晚期慢性肾病患者。方法：在压力测试中，我们随机分配了777例晚期肾脏疾病和中度或重度缺血患者，对他们进行初始侵入性治疗，包括冠状动脉造影和血运重建术（如果合适）加药物治疗，或初始保守性治疗，包括单独药物治疗和血管造影，用于药物治疗失败的患者。主要结局是死亡或非致死性心肌梗死的综合结果。一个关键的次要结局是死亡、非致死性心肌梗死、因不稳定心绞痛、心力衰竭或复苏的心脏骤停住院的综合结果。结果中位随访时间为2.2年，侵入性策略组123例患者发生主要结局事件，保守性策略组129例患者发生主要结局事件（估计3年事件发生率为36.4% vs 36.7%；调整后风险比为1.01；95%可信区间[CI]， 0.79 ~ 1.29； P=0.95）。关键次要结局的结果相似（38.5%对39.7%；风险比1.01;95% CI 0.79 ~ 1.29）。有创策略比保守策略与更高的卒中发生率相关（风险比，3.76;95% CI， 1.52至9.32；P=0.004），与更高的死亡或开始透析的发生率相关（风险比，1.48;95% CI， 1.04至2.11；P=0.03）。结论：在稳定性冠状动脉疾病、晚期慢性肾脏疾病和中度或重度缺血患者中，我们没有发现证据表明，与初始保守策略相比，初始侵入策略可以降低死亡或非致死性心肌梗死的风险。（由国家心脏，肺和血液研究所和其他机构资助；缺血-慢性肾脏病临床试验。gov号码，NCT01985360。）
Background Clinical trials that have assessed the effect of revascularization in patients with stable coronary disease have routinely excluded those with advanced chronic kidney disease.Methods We randomly assigned 777 patients with advanced kidney disease and moderate or severe ischemia on stress testing to be treated with an initial invasive strategy consisting of coronary angiography and revascularization (if appropriate) added to medical therapy or an initial conservative strategy consisting of medical therapy alone and angiography reserved for those in whom medical therapy had failed. The primary outcome was a composite of death or nonfatal myocardial infarction. A key secondary outcome was a composite of death, nonfatal myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest.Results At a median follow-up of 2.2 years, a primary outcome event had occurred in 123 patients in the invasive-strategy group and in 129 patients in the conservative-strategy group (estimated 3-year event rate, 36.4% vs. 36.7%; adjusted hazard ratio, 1.01; 95% confidence interval [CI], 0.79 to 1.29; P=0.95). Results for the key secondary outcome were similar (38.5% vs. 39.7%; hazard ratio, 1.01; 95% CI, 0.79 to 1.29). The invasive strategy was associated with a higher incidence of stroke than the conservative strategy (hazard ratio, 3.76; 95% CI, 1.52 to 9.32; P=0.004) and with a higher incidence of death or initiation of dialysis (hazard ratio, 1.48; 95% CI, 1.04 to 2.11; P=0.03).Conclusions Among patients with stable coronary disease, advanced chronic kidney disease, and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of death or nonfatal myocardial infarction. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA-CKD ClinicalTrials.gov number, NCT01985360.)