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他汀类药物-依折麦布联合治疗对伴或不伴慢性肾脏病患者冠状动脉粥样斑块的影响 - PRECISE-IVUS 试验的亚组分析。

Impact of statin-ezetimibe combination on coronary atheroma plaque in patients with and without chronic kidney disease - Sub-analysis of PRECISE-IVUS trial.

机构信息

Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.

Department of Cardiovascular Medicine, Fukuoka Tokushukai Medical Center, Kasuga, Japan.

出版信息

Int J Cardiol. 2018 Oct 1;268:23-26. doi: 10.1016/j.ijcard.2018.04.051. Epub 2018 Jun 18.

DOI:10.1016/j.ijcard.2018.04.051
PMID:29925472
Abstract

BACKGROUND

Chronic kidney disease (CKD) deteriorates the prognosis of patients undergoing percutaneous coronary intervention (PCI). Because coronary artery disease (CAD) is the major cause of death in CKD patients, cardiovascular risk reduction has been clinically important in CKD. We hypothesized intensive lipid-lowering with statin/ezetimibe attenuated coronary atherosclerotic development even in patients with CKD.

METHODS

In the prospective, randomized, controlled, multicenter PRECISE-IVUS trial, 246 patients undergoing intravascular ultrasound (IVUS)-guided PCI were randomly assigned to receive atorvastatin/ezetimibe combination or atorvastatin alone (the dosage of atorvastatin was up-titrated to achieve the level of low-density lipoprotein cholesterol < 70 mg/dL). Serial volumetric IVUS findings obtained at baseline and 9-12 month follow-up to quantify the coronary plaque response in 202 patients were compared stratified by the presence or absence of CKD.

RESULTS

CKD was observed in 52 patients (26%) among 202 enrolled patients. Compared with the non-CKD group, the CKD group was significantly older (71.5 ± 8.6 years vs. 64.4 ± 9.6 years, P < 0.001) with similar prevalence of comorbid coronary risk factors and lipid profiles. Similar to the non-CKD group (-1.4 [-2.8 to -0.1]% vs. -0.2 [-1.7 to 1.0]%, P = 0.002), the atorvastatin/ezetimibe combination significantly reduced ∆PAV compared with atorvastatin alone even in the CKD group (-2.6 [-5.6 to -0.4]% vs. -0.9 [-2.4 to 0.2]%, P = 0.04).

CONCLUSIONS

As with non-CKD, intensive lipid-lowering therapy with atorvastatin/ezetimibe demonstrated stronger coronary plaque regression effect even in patients with CKD compared with atorvastatin monotherapy.

TRIAL REGISTRATION

NCT01043380 (ClinicalTrials.gov).

摘要

背景

慢性肾脏病(CKD)会使接受经皮冠状动脉介入治疗(PCI)的患者预后恶化。由于冠状动脉疾病(CAD)是 CKD 患者的主要死亡原因,因此在 CKD 患者中,降低心血管风险一直具有重要的临床意义。我们假设他汀类药物/依折麦布的强化降脂治疗可以减轻即使在 CKD 患者中也可以减轻冠状动脉粥样硬化的发展。

方法

在前瞻性、随机、对照、多中心的 PRECISE-IVUS 试验中,246 名接受血管内超声(IVUS)指导的 PCI 的患者被随机分为阿托伐他汀/依折麦布联合治疗组或阿托伐他汀单药治疗组(阿托伐他汀的剂量递增至低密度脂蛋白胆固醇<70mg/dL)。对 202 名患者的基线和 9-12 个月随访的容积 IVUS 结果进行了比较,并按是否存在 CKD 进行了分层。

结果

在 202 名入组患者中,有 52 名(26%)患者存在 CKD。与非 CKD 组相比,CKD 组患者年龄明显较大(71.5±8.6 岁 vs. 64.4±9.6 岁,P<0.001),且合并冠心病危险因素和血脂谱相似。与非 CKD 组相似(-1.4[-2.8 至-0.1]% vs. -0.2[-1.7 至 1.0]%,P=0.002),即使在 CKD 组,阿托伐他汀/依折麦布联合治疗也显著降低了与阿托伐他汀单药治疗相比,PAV 的变化(-2.6[-5.6 至-0.4]% vs. -0.9[-2.4 至 0.2]%,P=0.04)。

结论

与非 CKD 患者一样,与阿托伐他汀单药治疗相比,阿托伐他汀/依折麦布强化降脂治疗在 CKD 患者中也显示出更强的冠状动脉斑块消退作用。

试验注册

NCT01043380(ClinicalTrials.gov)。

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