Effect of very high-intensity statin therapy on regression of coronary atherosclerosis - The ASTEROID trial
Effect of very high-intensity statin therapy on regression of coronary atherosclerosis - The ASTEROID trial
复制标题
DOI：
10.1001/jama.295.13.jpc60002
复制
发表时间：
2006-04-05
影响因子：
120.7
通讯作者：
Tuzcu, EM
中科院分区：
文献类型：
--
作者：
Nissen, SE;Nicholls, SJ;Tuzcu, EM
背景血管内超声（IVUS）试验已经证明他汀类药物治疗可以减缓或阻止动脉粥样硬化的进展，但没有令人信服的证据表明动脉粥样硬化体积百分比（PAV）可以消退，PAV是IVUS测量疾病进展和消退的最严格指标。在美国、加拿大、欧洲和澳大利亚的53个社区和三级护理中心进行了一项开放标签设盲终点试验（一项评价瑞舒伐他汀对血管内超声衍生的冠状动脉粥样硬化负荷[ASTERVET]影响的研究）。在基线和治疗24个月后，使用电动IVUS回撤评估冠状动脉粥样硬化负荷。在2002年11月至2003年10月期间，507名患者进行了基线IVUS检查，并接受了至少1剂研究药物。24个月后，349例患者进行了可评估的系列IVUS examination.Intervention所有患者接受了瑞舒伐他汀，40 mg/d的强化他汀类药物治疗。主要结果测量两个主要疗效参数预先规定：PAV的变化和在10 mm的亚段与最大的疾病严重程度在基线的名义动脉粥样硬化体积的变化。结果低密度脂蛋白胆固醇（LDL-C）平均基线水平从130.4（34.3）mg/dL下降到60.8（20.0）mg/dL，平均下降53.2%（P
Context Prior intravascular ultrasound (IVUS) trials have demonstrated slowing or halting of atherosclerosis progression with statin therapy but have not shown convincing evidence of regression using percent atheroma volume (PAV), the most rigorous IVUS measure of disease progression and regression.Objective To assess whether very intensive statin therapy could regress coronary atherosclerosis as determined by IVUS imaging.Design and Setting Prospective, open-label blinded end-points trial ( A Study to Evaluate the Effect of Rosuvastatin on Intravascular Ultrasound-Derived Coronary Atheroma Burden [ ASTEROID]) was performed at 53 community and tertiary care centers in the United States, Canada, Europe, and Australia. A motorized IVUS pullback was used to assess coronary atheroma burden at baseline and after 24 months of treatment. Each pair of baseline and follow-up IVUS assessments was analyzed in a blinded fashion.Patients Between November 2002 and October 2003, 507 patients had a baseline IVUS examination and received at least 1 dose of study drug. After 24 months, 349 patients had evaluable serial IVUS examinations.Intervention All patients received intensive statin therapy with rosuvastatin, 40 mg/d.Main Outcome Measures Two primary efficacy parameters were prespecified: the change in PAV and the change in nominal atheroma volume in the 10-mm subsegment with the greatest disease severity at baseline. A secondary efficacy variable, change in normalized total atheroma volume for the entire artery, was also prespecified.Results The mean (SD) baseline low-density lipoprotein cholesterol (LDL-C) level of 130.4 (34.3) mg/dL declined to 60.8 (20.0) mg/dL, a mean reduction of 53.2% ( P