Center of Diabetes, Endocrine and Metabolism, Toho University Sakura Medical Center.
Nagayama Clinic.
J Atheroscler Thromb. 2021 Oct 1;28(10):1083-1094. doi: 10.5551/jat.60343. Epub 2020 Dec 18.
In the TOHO Lipid Intervention Trial Using Pitavastatin (TOHO-LIP), a multicenter randomized controlled trial, pitavastatin significantly reduced cardiovascular (CV) events compared to atorvastatin in patients with hypercholesterolemia. To investigate the mechanism by which pitavastatin preferentially prevents CV events, we investigated the relationship between CV events and cardio-ankle vascular index (CAVI) using the TOHO-LIP database.
For the subgroup analysis, we selected patients from a single center, Toho University Sakura Medical Center. After excluding those who had CV events at baseline or during the first year, 254 patients were enrolled. The primary end point was the same as that of TOHO-LIP, and three-point major cardiac adverse events (3P-MACE) was added as secondary end point.
The cumulative 5-year incidence of 3P-MACE (pitavastatin 1.6%, atorvastatin 6.1%, P=0.038) was significantly lower in pitavastatin group (2 mg/day) than in atorvastatin group (10 mg/day). CAVI significantly decreased only in pitavastatin group during the first year (9.50-9.34, P=0.042), while the change in low-density lipoprotein cholesterol (LDL-C) did not differ between the two groups. The change in CAVI during the first year positively correlated with 3P-MACE and tended to be an independent predictor of 3P-MACE in Cox proportional hazards model (hazard ratio, 1.736; P=0.079). The annual change in CAVI throughout the observation period was significantly higher in subjects with CV events compared to those without.
In this subgroup analysis, the reduction in CV events tended to be associated with the CAVI-lowering effect of pitavastatin, which was independent of the LDL-C-lowering effect.
在多中心随机对照试验——东邦脂质干预试验（TOHO-LIP）中，与阿托伐他汀相比，匹伐他汀可显著降低高胆固醇血症患者的心血管（CV）事件。为了探讨匹伐他汀优先预防 CV 事件的机制，我们使用 TOHO-LIP 数据库研究了 CV 事件与心血管踝臂指数（CAVI）之间的关系。
对于亚组分析，我们从单中心——东京医科齿科大学附属樱医疗中心选择患者。排除基线或第一年发生 CV 事件的患者后，共纳入 254 例患者。主要终点与 TOHO-LIP 相同，添加三点主要心脏不良事件（3P-MACE）作为次要终点。
5 年累积 3P-MACE 发生率（匹伐他汀组 1.6%，阿托伐他汀组 6.1%，P=0.038）显著低于阿托伐他汀组（10 mg/日）。仅在匹伐他汀组，CAVI 在第一年显著降低（9.50-9.34，P=0.042），而两组的低密度脂蛋白胆固醇（LDL-C）变化无差异。第一年 CAVI 的变化与 3P-MACE 呈正相关，在 Cox 比例风险模型中，CAVI 的变化倾向于成为 3P-MACE 的独立预测因子（危险比，1.736；P=0.079）。在观察期内，CAVI 的年变化在发生 CV 事件的患者中显著高于未发生 CV 事件的患者。
在本次亚组分析中，CV 事件的减少倾向于与匹伐他汀降低 CAVI 的作用相关，这与 LDL-C 降低作用无关。
