Kawashiri Masa-Aki, Sakata Kenji, Hayashi Kenshi, Gamou Tadatsugu, Kanaya Honin, Miwa Kenji, Ueda Kosei, Higashikata Toshinori, Mizuno Sumio, Michishita Ichiro, Namura Masanobu, Nitta Yutaka, Katsuda Shoji, Okeie Kazuyasu, Hirase Hiroaki, Tada Hayato, Uchiyama Katsuharu, Konno Tetsuo, Ino Hidekazu, Nagase Keisuke, Yamagishi Masakazu
Department of Cardiovascular and Internal Medicine, Kanazawa University Graduate School of Medicine, 13-1 Takara-machi, Kanazawa, 920-8641, Japan.
Department of Cardiology, Ishikawa Prefectural Central Hospital, Kanazawa, Japan.
Heart Vessels. 2017 May;32(5):539-548. doi: 10.1007/s00380-016-0910-2. Epub 2016 Oct 31.
The aim of the study was to elucidate the aggressive reduction of both low-density lipoprotein cholesterol (LDL-C) and blood pressure (BP) reduced coronary atherosclerotic plaque volume compared with a standard treatment of LDL-C and BP in Japanese patients with coronary artery disease (CAD). This study is a prospective, randomized, and open-labelled with a blind-endpoint evaluation study. A total of 97 patients (81 men, mean age 62.0 ± 9.6) with CAD undergoing intravascular ultrasonography (IVUS)-guided percutaneous coronary intervention (PCI) were randomized, and 68 patients had IVUS examinations at baseline and at 18-24 months follow-up. Patients were randomly assigned to standard or aggressive strategies targeting LDL-C and a BP of 100 mg/dL and 140/90 mmHg vs. 70 mg/dL and 120/70 mmHg, respectively. The primary endpoint was the percent change in coronary plaque volume. Both standard and aggressive strategies succeeded to achieve target levels of LDL-C and BP; 74.9 ± 14.7 vs. 63.7 ± 11.9 mg/dL (NS) and 124.1 ± 9.4/75.8 ± 7.7 vs. 113.6 ± 9.6/65.8 ± 9.4 mmHg (systolic BP; NS, diastolic BP; p < 0.05), respectively. Both groups showed a significant reduction in the coronary plaque volume of -9.4 ± 10.7% and -8.7 ± 8.6% (NS) in standard and aggressive therapies, respectively. Both standard and aggressive intervention significantly regressed coronary plaque volume by the same degree, suggesting the importance of simultaneous reductions of LDL-C and BP for prevention of CAD.
本研究的目的是阐明,与日本冠心病(CAD)患者低密度脂蛋白胆固醇(LDL-C)和血压(BP)的标准治疗相比,积极降低LDL-C和BP是否能减少冠状动脉粥样硬化斑块体积。本研究是一项前瞻性、随机、开放标签且采用盲终点评估的研究。共有97例接受血管内超声(IVUS)引导下经皮冠状动脉介入治疗(PCI)的CAD患者(81例男性,平均年龄62.0±9.6岁)被随机分组,68例患者在基线及18 - 24个月随访时接受了IVUS检查。患者被随机分配至针对LDL-C和BP的标准或积极策略组,标准策略组目标为LDL-C 100mg/dL和BP 140/90mmHg,积极策略组目标为LDL-C 70mg/dL和BP 120/70mmHg。主要终点是冠状动脉斑块体积的变化百分比。标准和积极策略均成功实现了LDL-C和BP的目标水平;分别为74.9±14.7 vs. 63.7±11.9mg/dL(无显著差异)以及124.1±9.4/75.8±7.7 vs. 113.6±9.6/65.8±9.4mmHg(收缩压:无显著差异,舒张压:p<0.05)。标准治疗组和积极治疗组冠状动脉斑块体积分别显著减少了-9.4±10.7%和-8.7±8.6%(无显著差异)。标准干预和积极干预均使冠状动脉斑块体积显著缩小相同程度,这表明同时降低LDL-C和BP对预防CAD具有重要意义。