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慢性冠状动脉疾病患者在肾功能不同阶段接受介入治疗与保守治疗的临床及生活质量结局。

Clinical and Quality-of-Life Outcomes Following Invasive vs Conservative Treatment of Patients With Chronic Coronary Disease Across the Spectrum of Kidney Function.

机构信息

New York University Grossman School of Medicine, New York.

Duke Clinical Research Institute, Durham, North Carolina.

出版信息

JAMA Cardiol. 2022 Aug 1;7(8):825-835. doi: 10.1001/jamacardio.2022.1763.

Abstract

IMPORTANCE

Prior trials of invasive vs conservative management of chronic coronary disease (CCD) have not enrolled patients with severe chronic kidney disease (CKD). As such, outcomes across kidney function are not well characterized.

OBJECTIVES

To evaluate clinical and quality-of-life (QoL) outcomes across the spectrum of CKD following conservative and invasive treatment strategies.

DESIGN, SETTING, AND PARTICIPANTS: Participants from the International Study of Comparative Health Effectiveness With Medical and Invasive Approaches (ISCHEMIA) and ISCHEMIA-Chronic Kidney Disease (CKD) trials were categorized by CKD stage: stage 1 (estimated glomerular filtration rate [eGFR] 90 mL/min/1.73m2 or greater), stage 2 (eGFR 60-89 mL/min/1.73m2), stage 3 (eGFR 30-59 mL/min/1.73m2), stage 4 (eGFR 15-29 mL/min/1.73m2), or stage 5 (eGFR less than 15 mL/min/1.73m2 or receiving dialysis). Enrollment took place from July 26, 2012, through January 31, 2018, with a median follow-up of 3.1 years. Data were analyzed from January 2020 to May 2021.

INTERVENTIONS

Initial invasive management of coronary angiography and revascularization with guideline-directed medical therapy (GDMT) vs initial conservative management of GDMT alone.

MAIN OUTCOMES AND MEASURES

The primary clinical outcome was a composite of death or nonfatal myocardial infarction (MI). The primary QoL outcome was the Seattle Angina Questionnaire (SAQ) summary score.

RESULTS

Among the 5956 participants included in this analysis (mean [SD] age, 64 [10] years; 1410 [24%] female and 4546 [76%] male), 1889 (32%), 2551 (43%), 738 (12%), 311 (5%), and 467 (8%) were in CKD stages 1, 2, 3, 4, and 5, respectively. By self-report, 18 participants (<1%) were American Indian or Alaska Native; 1676 (29%), Asian; 267 (5%), Black; 861 (16%), Hispanic or Latino; 18 (<1%), Native Hawaiian or Other Pacific Islander; 3884 (66%), White; and 13 (<1%), multiple races or ethnicities. There was a monotonic increase in risk of the primary composite end point (3-year rates, 9.52%, 10.72%, 18.42%, 34.21%, and 38.01% respectively), death, cardiovascular death, MI, and stroke in individuals with higher CKD stages. Invasive management was associated with an increase in stroke (3-year event rate difference, 1%; 95% CI, 0.3 to 1.7) and procedural MI (1.6%; 95% CI, 0.9 to 2.3) and a decrease in spontaneous MI (-2.5%; 95% CI, -3.9 to -1.1) with no difference in other outcomes; the effect was similar across CKD stages. There was heterogeneity of treatment effect for QoL outcomes such that invasive management was associated with an improvement in angina-related QoL in individuals with CKD stages 1 to 3 and not in those with CKD stages 4 to 5.

CONCLUSIONS AND RELEVANCE

Among participants with CCD, event rates were inversely proportional to kidney function. Invasive management was associated with an increase in stroke and procedural MI and a reduced risk in spontaneous MI, and the effect was similar across CKD stages with no difference in other outcomes, including death. The benefit for QoL with invasive management was not observed in individuals with poorer kidney function.

摘要

重要性

先前关于慢性冠状动脉疾病(CCD)的有创与保守治疗的试验并未纳入严重慢性肾脏病(CKD)患者。因此,肾功能不全的各项结果并未得到很好的描述。

目的

评估保守和有创治疗策略后 CKD 患者的临床和生活质量(QoL)结果。

设计、地点和参与者:参与者来自国际比较医疗效果与有创和保守治疗方法(ISCHEMIA)和 ISCHEMIA-慢性肾脏病(CKD)试验,按 CKD 分期分类:第 1 期(估计肾小球滤过率[eGFR]90 mL/min/1.73m2 或更高)、第 2 期(eGFR 60-89 mL/min/1.73m2)、第 3 期(eGFR 30-59 mL/min/1.73m2)、第 4 期(eGFR 15-29 mL/min/1.73m2)或第 5 期(eGFR 低于 15 mL/min/1.73m2 或正在接受透析)。招募于 2012 年 7 月 26 日至 2018 年 1 月 31 日进行,中位随访 3.1 年。数据分析于 2020 年 1 月至 2021 年 5 月进行。

干预措施

初始有创治疗方案为冠状动脉造影和血管重建术联合指南指导的药物治疗(GDMT),或初始保守治疗方案为 GDMT 单独治疗。

主要结果和测量指标

主要临床结局为死亡或非致死性心肌梗死(MI)的复合结局。主要 QoL 结局为西雅图心绞痛问卷(SAQ)综合评分。

结果

在本分析中,5956 名参与者(平均[SD]年龄,64[10]岁;1410[24%]为女性,4546[76%]为男性)中,1889 名(32%)、2551 名(43%)、738 名(12%)、311 名(5%)和 467 名(8%)分别处于 CKD 分期 1、2、3、4 和 5。根据自我报告,18 名参与者(<1%)为美洲印第安人或阿拉斯加原住民;1676 名(29%)为亚洲人;267 名(5%)为黑人;861 名(16%)为西班牙裔或拉丁裔;18 名(<1%)为夏威夷原住民或其他太平洋岛民;3884 名(66%)为白人;13 名(<1%)为多种族或多种族裔。主要复合终点(3 年发生率分别为 9.52%、10.72%、18.42%、34.21%和 38.01%)、死亡、心血管死亡、MI 和中风的风险随 CKD 分期的升高而逐渐增加。有创治疗与中风(3 年事件发生率差异,1%;95%CI,0.3 至 1.7)和经皮冠状动脉介入治疗相关 MI(1.6%;95%CI,0.9 至 2.3)的增加相关,与其他结局无差异;该效果在各 CKD 分期中相似。治疗效果在 QoL 结局方面存在异质性,即 CKD 分期 1 至 3 期的患者有创治疗与心绞痛相关 QoL 的改善相关,而 CKD 分期 4 至 5 期的患者则无此关联。

结论和相关性

在 CCD 患者中,事件发生率与肾功能呈反比。有创治疗与中风和经皮冠状动脉介入治疗相关 MI 的增加以及自发性 MI 风险的降低相关,该效果在各 CKD 分期中相似,其他结局(包括死亡)无差异。有创治疗对 QoL 的益处并未在肾功能较差的患者中观察到。

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