冠状动脉支架术后阿托伐他汀或普伐他汀与氯吡格雷联合治疗的远期疗效比较:随机对照试验

目的 比较冠状动脉支架术后阿托伐他汀和普伐他汀与氯吡格雷联合应用的长期疗效.方法 入选2006年2月至2007年3月成功实施冠脉支架术的住院冠心病患者共1275例,术后638例随机接受阿托伐他汀20 mg/d,637例接受普伐他汀20 mg/d治疗,两组患者均接受常规剂最氯吡格霄治疗.研究主要终点为12个月心脑血管缺血事件,包括心血管死亡、非致死性心肌梗死(MI)及卒中,次要终点为12个月主要不良心脑血管事件(MACCE)、支架血栓及TIMI出血事件.结果两组临床基线资料、冠脉造影及冠状动脉支架术结果差异无统计学意义.12个月临床随访结果显示,两组心脑血管缺血事件发生率差异无统计学意义(阿托伐他汀组4.7%,普伐他汀组5.5%,P>0.05).阿托伐他汀组死亡、非致死性MI、卒中和靶血管血运重建发生率(分别为1.9%、0.5%、2.4%、7.7%)与普伐他汀组(分别为2.5%、0.3%、2.7%、5.5%)比较差异无统计学意义(P>0.05).阿托伐他汀组MACCE发生率与普伐他汀组比较差异无统计学意义(12.4%比11.0%,P>0.05).两组支架血栓发生率差异无统计学意义(2.0%比2.5%,P>0.05).出血事件发生率差异无统计学意义(13.0%比12.2%,P>0.05).结论 冠状动脉支架术后患者采用阿托伐他汀20 mg/d或普伐他汀20 mg/d联合氯吡格雷治疗的12个月疗效相近,提示两种不同代谢途径的他汀与氯吡格雷合用均安全、有效.

Comparison on long-term effects of atorvastatin or provastatin combined with clopidogrel for patients undergoing coronary stenting: a randomized controlled trial

Objective To evaluate the long-term therapeutic effects of atorvastatin via cytochrome P450 (CYP)3 A4 pathway or a non-CYP 3 A4 pathway statin, provastatin, combined with clopidogrel for the patients undergoing coronary stenting. Methods Between February 2006 and March 2007, a total of 1275 patients undergoing successful coronary stenting were randomly assigned to receive atorvastatin 20 mg/d (n = 638 ) or provastatin 20 mg/d (n = 637 ). All patients received standard clopidogrel therapy. The primary end point was cardiac and cerebral ischemic events at 12 months, defined as a composite of cardiac death, non-fatal myocardial infarction (MI) or stroke. The secondary end points were major adverse cardiac and cerebral events ( MACCE), stent thrombosis and TIMI hemorrhagic events at 12 months. Results The baseline clinical characteristics, angiographic and PCI result were comparable between two groups. At 12 month follow-up, no significant difference was observed in cardiac and cerebral ischemic events between two groups (4.7% vs 5.5 %, P >0.05). Also no significant difference existed in rate of cardiac death (1.9% vs 2.5%, P>0.05), non-fatal MI (0.5% vs0.3% , P>0.05), stroke (2.4% vs2.7%, P> 0.05) and TVR (7.7% vs 5.5 %, P >0.05) between two groups. The rates of MACCE (12.4% vs 11.0%, P>0.05), stent thrombosis (2.0% vs 2.5%, P>0.05) and hemorrhagic events (13.0% vs 12.2%, P >0.05) were similar between two groups. Conclusion The 12 month clinical outcomes were similar between patients receiving atorvastatin 20 mg/d or provastatin 20 mg/d combined with clopidogrel after coronary stenting. It confirmed the efficacy and safety of the combination of clopidogrel with statins via different metabolic pathways.