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[ESC/WCC2006]解析ACEI用于无心衰的稳定型血管疾病的荟萃分析长海医院心内科 吴弘

作者:国际循环网   日期:2006/9/16 0:00:00

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在WCC的Clinical Trial Update专场报告中,Dagenais公布了ACEI用于无心衰的稳定型血管疾病的大型临床试验的荟萃分析结果,相关论文已在近期的LANCET杂志发表。 Dagenais等通过对HOPE、EUROPA、PEACE三大ACEI药物临床试验进行严格的系统回顾,以明确ACEI减少致死性和非致死性心血管事件是否具有一致性, 并评价不同危险水平以及接受过其它治疗的患者的获益情况。三大试验共计入选29805名无心衰的动脉粥样硬化患者,平均随访时间4.5年。荟萃分析显示,ACEI降低了联合事件(心血管死亡、非致命性心肌梗死和卒中)发生率(10.7%v12.8%,p<0.0001);同时降低了全因死亡率(7.8%v8.9%)、心血管死亡率(4.3%v5.2%)、非致死性心肌梗塞(5.3%v6.4%)、卒中(2.2%v2.8%)、心衰(2.1%v2.7%)、冠脉搭桥(6.0%v6.9%,p=0.0036),但没有减少PCI的实施(7.4%v7.6%, p=0.481)。与伴有心衰或左室收缩功能不全的其它五个随机试验比较,除卒中和血运重建外,其它结果一致。在HOPE、EUROPA试验中,治疗组联合事件OR值降低15%至30%,PEACE试验降低7%。近来研究提示ACEI可能存在一个治疗阈值,超出此阈值的低危冠心病患者ACEI治疗没有益处,这一假设在HOPE、EUROPA低危患者中并没得到证实。在HOPE和EUROPA试验中,无论是单独还是同时接受过β受体阻滞剂、调脂药、抗血小板药物、血运重建的患者,应用ACEI药物都可获益。 值得一提的是,三大试验所入选的病例高血压患者所占比例低于45%,进一步表明ACEI药物对联合事件、全因死亡率、心血管死亡率及非致死性心肌梗死、卒中等心脑血管事件的降低是独立于降压作用以外的。三大试验荟萃分析显示,ACEI药物适用于接受过其它有效治疗的冠心病低危患者。这一研究提示,所有能够耐受且绝对益处评估有利的血管性疾病患者,应接受ACEI药物治疗。 附录: Dagenais会议报告 

Hot Lines and Clinical Trial Updates
Session Number : 710011Session Title: Clinical Trial Update I Core syllabus topic : Clinical pharmacology Date : 6 September 2006Reported by : Dagenais, G.R. Overview of large randomised trials of angiotensin-converting enzyme inhbitors in patients with stable vascular disease without left ventricular systolic dysfunction or heart failure in the context of previous large trials. We undertook a systematic review of the HOPE, EUROPA and PEACE trials to determine the consistency with which ACE-inhibitors reduce fatal and non-fatal cardiovascular events, and to explore whether benefits varied between patients with varying levels of risk or by ancillary treatments. There was consistency on different outcomes between the 3 trials. ACE inhibitors reduced the composite outcomes of cardiovascular mortality, non-fatal myocardial infarction or stroke [10.7% (1599/14913) v 12.8% (1910/14892) p< 0.0001] as well as (all P < 0.001) all-cause mortality (7.8 v 8.9%), cardiovascular mortality ( 4.3% v 5.2%), non-fatal myocardial infarction (5.3 v 6.4%), all stroke (2.2 v 2.8%) , heart failure (HF) (2.1 v 2.7%), coronary artery bypass surgery (6.0 v 6.9%, p = 0.0036) but not percutaneous coronary intervention (7.4 v 7.6%, p = 0.481). Except for stroke and revascularization, these results were similar to those of the 5 trials in patients with HF or LVSD.The odds reduction (OR) for the composite outcomes varies between 15 to 30% for the different trials irrespective of their annual rates of events in the placebo groups except for PEACE that had a 7% OR reduction for a 2.13% event rate. This last finding suggests that there may be a threshold beyond which ACE inhibitors have no benefits in low-risk CAD patients. However, this possibility was not confirmed with low-risk patients from HOPE and EUROPA (Fig.1). The benefits of the ACE inhibitors were observed among combined EUROPA and HOPE patients taking betablockers, lipid lowering agents and antiplatelets individually or together, and/or having undergone coronary revascularization (Fig. 2). The benefits of ACE inhibitors are consistent, observed in addition to other proven therapies, and even in low-risk CAD patients. Therefore, ACE inhibitors should be considered in all patients with vascular disease as long as they can tolerate these agents and the absolute benefits are judged to be worthy. Slide presentation [Available]

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