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在 ISCHEMIA-CKD 试验中,透析与非透析慢性肾脏病患者中指南指导的药物治疗达标情况与结局。

Guideline-Directed Medical Therapy Attainment and Outcomes in Dialysis-Requiring Versus Nondialysis Chronic Kidney Disease in the ISCHEMIA-CKD Trial.

机构信息

Department of Medicine, Loma Linda VA Health Care System, CA (R.O.M.).

Loma Linda University School of Medicine, Loma Linda, CA (R.O.M.).

出版信息

Circ Cardiovasc Qual Outcomes. 2022 Oct;15(10):e008995. doi: 10.1161/CIRCOUTCOMES.122.008995. Epub 2022 Oct 4.

Abstract

BACKGROUND

Patients with chronic kidney disease (CKD) on dialysis (CKD G5D) have worse cardiovascular outcomes than patients with advanced nondialysis CKD (CKD G4-5: estimated glomerular filtration rate <30 mL/[min·1.73m]). Our objective was to evaluate the relationship between achievement of cardiovascular guideline-directed medical therapy (GDMT) goals and clinical outcomes for CKD G5D versus CKD G4-5.

METHODS

This was a subgroup analysis of ISCHEMIA-CKD (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches-Chronic Kidney Disease) participants with CKD G4-5 or CKD G5D and moderate-to-severe myocardial ischemia on stress testing. Exposures included dialysis requirement at randomization and GDMT goal achievement during follow-up. The composite outcome was all-cause mortality or nonfatal myocardial infarction. Individual GDMT goal (smoking cessation, systolic blood pressure <140 mm Hg, low-density lipoprotein cholesterol <70 mg/dL, statin use, aspirin use) trajectory was modeled. Percentage point difference was estimated for each GDMT goal at 24 months between CKD G5D and CKD G4-5, and for association with key predictors. Probability of survival free from all-cause mortality or nonfatal myocardial infarction by GDMT goal achieved was assessed for CKD G5D versus CKD G4-5.

RESULTS

A total of 415 CKD G5D and 362 CKD G4-5 participants were randomized. Participants with CKD G5D were less likely to receive statin (-6.9% [95% CI, -10.3% to -3.7%]) and aspirin therapy (-3.0% [95% CI, -5.6% to -0.6%]), with no difference in other GDMT goal attainment. Cumulative exposure to GDMT achieved during follow-up was associated with reduction in all-cause mortality or nonfatal myocardial infarction (hazard ratio, 0.88 [95% CI, 0.87-0.90]; per each GDMT goal attained over 60 days), irrespective of dialysis status.

CONCLUSIONS

CKD G5D participants received statin or aspirin therapy less often. Cumulative exposure to GDMT goals achieved was associated with lower incidence of all-cause mortality or nonfatal myocardial infarction in participants with advanced CKD and chronic coronary disease, regardless of dialysis status.

REGISTRATION

URL: https://www.

CLINICALTRIALS

gov; Unique identifier: NCT01985360.

摘要

背景

与进展性非透析慢性肾脏病(CKD G4-5:估算肾小球滤过率<30 mL/[min·1.73m])相比,透析(CKD G5D)的慢性肾脏病(CKD)患者心血管结局更差。我们的目的是评估在 CKD G5D 与 CKD G4-5 患者中,实现心血管指南指导的药物治疗(GDMT)目标与临床结局之间的关系。

方法

这是 ISCHEMIA-CKD(国际比较健康效果研究与药物和介入治疗慢性肾脏病)参与者的亚组分析,这些参与者患有 CKD G4-5 或 CKD G5D,并且在应激测试中有中度至重度心肌缺血。暴露因素包括随机分组时的透析需求和随访期间 GDMT 目标的实现。复合结局是全因死亡率或非致死性心肌梗死。个体 GDMT 目标(戒烟、收缩压<140 mmHg、低密度脂蛋白胆固醇<70 mg/dL、他汀类药物使用、阿司匹林使用)轨迹建模。估计在 24 个月时 CKD G5D 和 CKD G4-5 之间每个 GDMT 目标的百分点差异,并评估与关键预测因素的关联。根据 CKD G5D 和 CKD G4-5 中 GDMT 目标的实现情况,评估全因死亡率或非致死性心肌梗死的生存概率。

结果

共纳入 415 例 CKD G5D 和 362 例 CKD G4-5 参与者。与 CKD G4-5 相比,CKD G5D 患者接受他汀类药物治疗的比例较低(-6.9%[95%CI:-10.3%至-3.7%])和阿司匹林治疗的比例较低(-3.0%[95%CI:-5.6%至-0.6%]),其他 GDMT 目标的实现情况则无差异。在随访期间累积接受 GDMT 治疗与全因死亡率或非致死性心肌梗死的降低相关(风险比,0.88[95%CI:0.87-0.90];每 60 天达到一个 GDMT 目标,风险比降低 0.88),无论透析状态如何。

结论

与 CKD G4-5 患者相比,CKD G5D 患者他汀类药物或阿司匹林治疗的使用率较低。在患有晚期 CKD 和慢性冠状动脉疾病的患者中,无论透析状态如何,实现 GDMT 目标的累积暴露与全因死亡率或非致死性心肌梗死发生率的降低相关。

登记

网址:https://www.clinicaltrials.gov;唯一标识符:NCT01985360。

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