Division of Cardiology, Department of Internal Medicine, Yokohama Sakae Kyosai Hospital.
J Atheroscler Thromb. 2013;20(9):717-25. doi: 10.5551/jat.18705. Epub 2013 Jun 8.
The TRUTH trial demonstrated that 8-month statin therapy alters the composition of coronary artery plaque using virtual histology (VH)-intravascular ultrasound (IVUS). The extended TRUTH study was conducted to evaluate the relationship between changes in coronary atherosclerosis and mid-term clinical outcomes and identify the factors associated with cardiovascular events.
Of 164 patients with angina pectoris who participated in the TRUTH trial, 119 subjects with analyzable IVUS data at both enrollment and the 8-month follow-up were enrolled and observed for at least two years. The primary end point was the time to first occurrence of cardiovascular composite events, including cardiovascular death, nonfatal myocardial infarction, nonfatal cerebral infarction, unstable angina and ischemic-driven revascularization, except for target lesion revascularization.
The frequency of reaching the primary end point was 13% (16/119), with a mean follow-up period of 41.9±9.4 months. Although plaque regression and changes in plaque composition were not associated with future cardiovascular events, the serum high-sensitivity C-reactive protein (hs-CRP) levels at the start of the extended TRUTH study were significantly higher in the event group than in the event-free group (1.43 mg/L vs. 0.58 mg/L, p=0.01). A multivariate logistic regression analysis showed that the hs-CRP level was an independent significant predictor of cardiovascular events (odds ratio: 1.69; 95% confidence interval: 1.14-2.50, p=0.01).
Coronary artery plaque regression and changes in plaque composition during statin therapy do not predict future cardiovascular events in patients with angina pectoris. Instead, the serum hs-CRP level can be used as a predictor of cardiovascular events.
TRUTH 试验表明,8 个月的他汀类药物治疗通过虚拟组织学(VH)-血管内超声(IVUS)改变了冠状动脉斑块的组成。扩展的 TRUTH 研究旨在评估冠状动脉粥样硬化变化与中期临床结果之间的关系,并确定与心血管事件相关的因素。
在参加 TRUTH 试验的 164 例心绞痛患者中,纳入了 119 例在入组时和 8 个月随访时均具有可分析的 IVUS 数据的患者,并观察至少两年。主要终点是首次发生心血管复合事件的时间,包括心血管死亡、非致死性心肌梗死、非致死性脑梗死、不稳定型心绞痛和缺血驱动的血运重建,但不包括靶病变血运重建。
达到主要终点的频率为 13%(16/119),平均随访时间为 41.9±9.4 个月。尽管斑块消退和斑块成分变化与未来心血管事件无关,但在扩展 TRUTH 研究开始时,事件组的血清高敏 C 反应蛋白(hs-CRP)水平明显高于无事件组(1.43mg/L 比 0.58mg/L,p=0.01)。多变量逻辑回归分析显示,hs-CRP 水平是心血管事件的独立显著预测因子(比值比:1.69;95%置信区间:1.14-2.50,p=0.01)。
在心绞痛患者中,他汀类药物治疗期间冠状动脉斑块的消退和斑块成分的变化不能预测未来的心血管事件。相反,血清 hs-CRP 水平可作为心血管事件的预测因子。