Department of Cardiovascular Medicine, Juntendo University, Bunkyo-ku, Tokyo, Japan.
Cardiovasc Drugs Ther. 2010 Feb;24(1):77-83. doi: 10.1007/s10557-010-6223-2.
Atherothrombotic disease is a major and increasing health problem in Japan. Effective secondary prevention of atherothrombotic events after acute coronary syndrome (ACS) is required, but clinical evidence regarding the current state of preventive treatment and the rate of subsequent atherothrombotic events after ACS in Japan is limited. Up-to-date Japanese epidemiological real world data are required to construct optimal evidence-based Japanese guidelines for the management of patients with ACS.
The PACIFIC (Prevention of AtherothrombotiC Incidents Following Ischemic Coronary attack) Registry is an ongoing, observational study of a large cohort of Japanese patients hospitalised with any manifestation of ACS (ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction or unstable angina [UA]). Up to 4,000 patients from approximately 100 sites nationwide will be enrolled and the primary study endpoint is the incidence of any major atherothrombotic event (cardiovascular, cerebrovascular or peripheral) between the initial ACS event and 2 years of follow-up. Secondary endpoints include fatal myocardial infarction (MI), fatal stroke, other cardiovascular death, non-cardiovascular death, non-fatal MI/UA, non-fatal stroke and acute peripheral arterial occlusion. Hospitalisation for vascular interventions will also be recorded, as will haemorrhage requiring hospitalisation or blood transfusion. The use of preventive treatment will also be reported and different patient subgroups (diabetes mellitus, hypertension, dyslipidaemia and metabolic syndrome) will be analysed. It is expected that the study will be completed in early to mid 2011.
The PACIFIC Registry will give insights as to the Japanese epidemiology of ACS: recurrence of atherothrombotic events in the same or other vascular territories.
动脉血栓栓塞疾病是日本一个日益严重的重大健康问题。急性冠状动脉综合征(ACS)后需要有效的二级预防动脉血栓栓塞事件,但目前日本预防治疗的临床证据和 ACS 后动脉血栓栓塞事件的发生率有限。需要最新的日本流行病学真实世界数据来构建 ACS 患者管理的最佳循证日本指南。
PACIFIC(缺血性冠状动脉事件后预防动脉血栓栓塞事件)注册研究是一项正在进行的、观察性的日本大型 ACS 患者队列研究(ST 段抬高心肌梗死、非 ST 段抬高心肌梗死或不稳定型心绞痛 [UA])。全国约 100 个地点将纳入多达 4000 例患者,主要研究终点是首次 ACS 事件后 2 年随访期间任何主要动脉血栓栓塞事件(心血管、脑血管或外周血管)的发生率。次要终点包括致死性心肌梗死(MI)、致死性卒中、其他心血管死亡、非心血管死亡、非致死性 MI/UA、非致死性卒中和急性外周动脉闭塞。还将记录因血管介入而住院治疗的情况,以及因出血需要住院或输血的情况。还将报告预防治疗的使用情况,并分析不同的患者亚组(糖尿病、高血压、血脂异常和代谢综合征)。预计研究将在 2011 年初至中期完成。
PACIFIC 登记研究将深入了解日本 ACS 的流行病学:同一或其他血管区域的动脉血栓栓塞事件复发情况。