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初始侵入性治疗晚期肾病冠脉疾病患者不优于保守方案
作者:小柯机器人 发布时间:2020/4/2 15:58:10

美国纽约大学格罗斯曼医学院Sripal Bangalore课题组的一项最新研究,探讨了晚期肾病患者冠状动脉疾病的管理策略。相关论文发表在2020年3月30日出版的《新英格兰医学杂志》上。

评估稳定型冠心病患者血运重建疗效的临床试验通常排除了晚期慢性肾病的患者。

研究组招募了777名晚期肾病、中度或重度缺血的患者,将其随机分组,分别接受初始侵入性治疗(包括冠脉造影和血运重建)联合药物治疗,或仅初始药物治疗的保守方案,保守治疗失败则行血管造影术。主要结局是死亡或非致命性心肌梗死的综合结果。关键次要结局是死亡,非致命性心肌梗死,或因不稳定型心绞痛、心力衰竭或心脏骤停复苏而住院的综合结果。

中位随访2.2年后,侵入性治疗组中有123例患者发生主要结局事件,保守方案组有129例,估计3年事件发生率分别为36.4%和36.7%,校正后的风险比为1.01。关键次要结局的3年事件发生率分别为38.5%和39.7%,风险比为1.01。侵入性治疗组的中风发生率和死亡或开始透析的发生率均显著高于保守方案组,风险比分别为3.76和1.48。

总之,对于患有稳定型冠脉疾病、晚期慢性肾病以及中度或重度缺血的患者中,没有证据表明与保守方案相比,初始侵入性治疗可降低死亡或非致命性心肌梗塞的风险。

附:英文原文

Title: Management of Coronary Disease in Patients with Advanced Kidney Disease | NEJM

Author: Sripal Bangalore, M.D., M.H.A.,, David J. Maron, M.D.,, Sean M. O’Brien, Ph.D.,, Jerome L. Fleg, M.D.,, Evgeny I. Kretov, M.D.,, Carlo Briguori, M.D., Ph.D.,, Upendra Kaul, M.D.,, Harmony R. Reynolds, M.D.,, Tomasz Mazurek, M.D., Ph.D.,, Mandeep S. Sidhu, M.D.,, Jeffrey S. Berger, M.D.,, Roy O. Mathew, M.D.,, Olga Bockeria, M.D.,, Samuel Broderick, M.S.,, Radoslaw Pracon, M.D.,, Charles A. Herzog, M.D.,, Zhen Huang, M.S.,, Gregg W. Stone, M.D.,, William E. Boden, M.D.,, Jonathan D. Newman, M.D., M.P.H.,, Ziad A. Ali, M.D., D.Phil.,, Daniel B. Mark, M.D., M.P.H.,, John A. Spertus, M.D.,, Karen P. Alexander, M.D.,, Bernard R. Chaitman, M.D.,, Glenn M. Chertow, M.D.,, and Judith S. Hochman, M.D.

Issue&Volume: 2020-03-30

Abstract: Abstract

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.

DOI: 10.1056/NEJMoa1915925

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1915925

 

期刊信息

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于美国麻省医学协会,最新IF:70.67
官方网址:http://www.nejm.org/
投稿链接:http://www.nejm.org/page/author-center/home