Veselka Josef, Zemánek David, Hájek Petr, Malý Martin, Adlová Radka, Martinkovicová Lucie, Tesar David
Department of Cardiology, CardioVascular Center, University Hospital, Charles University Motol Medical School I, Prague, Czech Republic.
Am J Cardiol. 2009 Sep 1;104(5):630-3. doi: 10.1016/j.amjcard.2009.04.048. Epub 2009 Jun 24.
Both randomized and observational studies have suggested that pretreatment with statins may reduce the incidence of periprocedural myocardial infarction (PMI) in patients with stable angina during elective percutaneous coronary intervention (PCI). The purpose of this randomized study (Clinical Trial Registration No. NCT00469326) was to investigate the effect of 2-day atorvastatin therapy on the incidence of PMI in patients with stable angina pectoris undergoing elective PCI. A total of 200 patients with stable angina pectoris who were not taking statins and who had been referred for PCI were enrolled and randomized (ratio 1:1) to a 2-day pretreatment regimen with atorvastatin 80 mg/day and subsequent PCI or immediate PCI. The serum concentration of creatine kinase-MB mass and troponin I were measured before and 16 to 24 hours after PCI. The incidence of PMI was assessed using established criteria. Of the patients, 10% in the atorvastatin group and 12% in the control group had a postprocedural creatine kinase-MB mass elevation > or =3 times the upper limit of normal (p = 0.65). The incidence of PMI as determined by the postinterventional release of troponin I > or =3 times the upper limit of normal was 17% in the atorvastatin group and 16% in the control group (p = 0.85). The median creatine kinase-MB mass peak after PCI was 1.46 ng/ml (interquartile range 0.83 to 2.52) in the atorvastatin group and 1.40 ng/ml (interquartile range 0.90 to 2.54) in the control group (p = 0.70). The median peak troponin I level after PCI was 0.100 ng/ml (0.096 to 0.385) in the atorvastatin group and 0.100 ng/ml (0.60 to 0.262) in the control group (p = 0.54). On multivariate analysis, the only independent predictor of PMI was patient age (odds ratio 1.09, 95% confidence interval 1.025 to 1.159, p = 0.006). In conclusion, in the present study 2-day pre-PCI therapy with atorvastatin did not reduce the occurrence of PMI in patients with stable angina pectoris undergoing elective PCI.
随机研究和观察性研究均表明，对于稳定型心绞痛患者，在择期经皮冠状动脉介入治疗（PCI）期间，术前使用他汀类药物可能会降低围手术期心肌梗死（PMI）的发生率。这项随机研究（临床试验注册号：NCT00469326）的目的是调查阿托伐他汀治疗2天对接受择期PCI的稳定型心绞痛患者PMI发生率的影响。共有200例未服用他汀类药物且被转诊接受PCI的稳定型心绞痛患者入组，并随机（比例1:1）分为两组，一组接受阿托伐他汀80mg/天的2天术前治疗方案，随后进行PCI；另一组直接进行PCI。在PCI术前及术后16至24小时测量肌酸激酶-MB质量和肌钙蛋白I的血清浓度。使用既定标准评估PMI的发生率。阿托伐他汀组10%的患者和对照组12%的患者术后肌酸激酶-MB质量升高超过或等于正常上限的3倍（p = 0.65）。介入后肌钙蛋白I释放超过或等于正常上限3倍所确定的PMI发生率，阿托伐他汀组为17%，对照组为16%（p = 0.85）。PCI术后肌酸激酶-MB质量峰值中位数，阿托伐他汀组为1.46ng/ml（四分位间距0.83至2.52），对照组为1.40ng/ml（四分位间距0.90至2.54）（p = 0.70）。PCI术后肌钙蛋白I峰值中位数，阿托伐他汀组为0.100ng/ml（0.096至0.385），对照组为0.100ng/ml（0.60至0.262）（p = 0.54）。多变量分析显示，PMI的唯一独立预测因素是患者年龄（比值比1.09，95%置信区间1.025至1.159，p = 0.006）。总之，在本研究中，对于接受择期PCI的稳定型心绞痛患者，PCI术前2天的阿托伐他汀治疗并未降低PMI的发生。
