OLIVUS-Ex(奥美沙坦对冠状动脉粥样硬化进展的影响:血管内超声评估)扩展试验的 4 年临床结果。

Four-year clinical outcomes of the OLIVUS-Ex (impact of Olmesartan on progression of coronary atherosclerosis: evaluation by intravascular ultrasound) extension trial.

机构信息

The Sakakibara Heart Institute of Okayama, Japan.

出版信息

Atherosclerosis. 2012 Jan;220(1):134-8. doi: 10.1016/j.atherosclerosis.2011.10.013. Epub 2011 Nov 9.

Abstract

BACKGROUND

The previous OLIVUS trial reported a positive role in achieving a lower rate of coronary atheroma progression through the administration of olmesartan, an angiotension-II receptor blocking agent (ARB), for stable angina pectoris (SAP) patients requiring percutaneous coronary intervention (PCI). However, the benefits between ARB administration on long-term clinical outcomes and serial atheroma changes by IVUS remain unclear. Thus, we examined the 4-year clinical outcomes from OLIVUS according to treatment strategy with olmesartan.

METHODS

Serial volumetric IVUS examinations (baseline and 14 months) were performed in 247 patients with hypertension and SAP. When these patients underwent PCI for culprit lesions, IVUS was performed in their non-culprit vessels. Patients were randomly assigned to receive 20-40mg of olmesartan or control, and treated with a combination of β-blockers, calcium channel blockers, glycemic control agents and/or statins per physician's guidance. Four-year clinical outcomes and annual progression rate of atherosclerosis, assessed by serial IVUS, were compared with major adverse cardio- and cerebrovascular events (MACCE).

RESULTS

Cumulative event-free survival was significantly higher in the olmesartan group than in the control group (p=0.04; log-rank test). By adjusting for validated prognosticators, olmesartan administration was identified as a good predictor of MACCE (p=0.041). On the other hand, patients with adverse events (n=31) had larger annual atheroma progression than the rest of the population (23.8% vs. 2.1%, p<0.001).

CONCLUSIONS

Olmesartan therapy appears to confer improved long-term clinical outcomes. Atheroma volume changes, assessed by IVUS, seem to be a reliable surrogate for future major adverse cardio- and cerebrovascular events in this study cohort.

摘要

背景

之前的 OLIVUS 试验报告称,对于需要经皮冠状动脉介入治疗(PCI)的稳定型心绞痛(SAP)患者,血管紧张素 II 受体阻滞剂(ARB)奥美沙坦可降低冠状动脉粥样硬化进展的发生率,从而发挥积极作用。然而,ARB 治疗对长期临床结局和 IVUS 检测的粥样斑块变化的获益尚不清楚。因此,我们根据奥美沙坦的治疗策略,检查了 OLIVUS 试验的 4 年临床结局。

方法

对 247 例高血压合并 SAP 患者进行了连续的血管内超声(IVUS)检查(基线和 14 个月)。当这些患者因罪犯病变而行 PCI 时,同时对其非罪犯血管进行 IVUS 检查。患者被随机分为奥美沙坦组(20-40mg)和对照组,两组患者均根据医生的指导联合使用β受体阻滞剂、钙通道阻滞剂、血糖控制药物和/或他汀类药物进行治疗。比较 4 年的临床结局和通过 IVUS 检测的粥样斑块年度进展率与主要不良心脑血管事件(MACCE)。

结果

奥美沙坦组的累积无事件生存率显著高于对照组(p=0.04;log-rank 检验)。在校正了经过验证的预后因素后,奥美沙坦的使用被确定为 MACCE 的良好预测因素(p=0.041)。另一方面,发生不良事件的患者(n=31)的年度粥样斑块进展率高于其余人群(23.8% vs. 2.1%,p<0.001)。

结论

奥美沙坦治疗似乎可改善长期临床结局。在本研究队列中,通过 IVUS 评估的粥样斑块体积变化似乎是未来发生主要不良心脑血管事件的可靠替代指标。

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