Di Sciascio Germano, Patti Giuseppe, Pasceri Vincenzo, Gaspardone Achille, Colonna Giuseppe, Montinaro Antonio
Department of Cardiovascular Sciences, Campus Bio-Medico University of Rome, Rome, Italy.
J Am Coll Cardiol. 2009 Aug 4;54(6):558-65. doi: 10.1016/j.jacc.2009.05.028. Epub 2009 Jul 2.
This study was designed to investigate whether an acute atorvastatin reload before percutaneous coronary intervention (PCI) protects patients receiving chronic statin therapy from periprocedural myocardial damage.
Previous ARMYDA (Atorvastatin for Reduction of Myocardial Damage During Angioplasty) studies demonstrated that short-term pre-treatment with atorvastatin reduces myocardial infarction during PCI in statin-naïve patients with both stable angina and acute coronary syndromes.
A total of 383 patients (age 66 +/- 10 years, 305 men) with stable angina (53%) or non-ST-segment elevation acute coronary syndromes (47%) and chronic statin therapy (55% atorvastatin) undergoing PCI were randomized to atorvastatin reload (80 mg 12 h before intervention, with a further 40-mg pre-procedural dose [n = 192]) or placebo (n = 191). All patients received long-term atorvastatin treatment thereafter (40 mg/day). The primary end point was 30-day incidence of major adverse cardiac events (cardiac death, myocardial infarction, or unplanned revascularization).
The primary end point occurred in 3.7% of patients treated with atorvastatin reload and in 9.4% in the placebo arm (p = 0.037); this difference was mostly driven by reduction in periprocedural myocardial infarction. There was lower incidence of post-procedural creatine kinase-myocardial band and troponin-I elevation greater than the upper limit of normal in the atorvastatin arm (13% vs. 24%, p = 0.017, and 37% vs. 49%, p = 0.021, respectively). Multivariable analysis identified atorvastatin reload as a predictor of decreased risk of 30-day incidence of major adverse cardiac events (odds ratio: 0.50, 95% confidence interval: 0.20 to 0.80; p = 0.039), mainly in patients with acute coronary syndromes (82% relative risk reduction; p = 0.027).
The ARMYDA-RECAPTURE trial suggests that reloading with high-dose atorvastatin improves the clinical outcome of patients on chronic statin therapy undergoing PCI. These findings may support a strategy of routine reload with high-dose atorvastatin early before intervention even in the background of chronic therapy.
本研究旨在调查经皮冠状动脉介入治疗（PCI）前急性重新负荷使用阿托伐他汀是否能保护接受慢性他汀治疗的患者免受围手术期心肌损伤。
既往ARMYDA（阿托伐他汀减少血管成形术期间心肌损伤）研究表明，阿托伐他汀短期预处理可降低稳定型心绞痛和急性冠状动脉综合征的他汀类药物初治患者PCI期间的心肌梗死发生率。
共有383例年龄66±10岁、男性305例，患有稳定型心绞痛（53%）或非ST段抬高急性冠状动脉综合征（47%）且正在接受慢性他汀治疗（55%为阿托伐他汀）并计划进行PCI的患者，被随机分为阿托伐他汀重新负荷组（干预前12小时服用80mg，术前再给予40mg剂量[n = 192]）或安慰剂组（n = 191）。此后所有患者均接受长期阿托伐他汀治疗（40mg/天）。主要终点为30天主要不良心脏事件（心脏死亡、心肌梗死或非计划血管重建）的发生率。
阿托伐他汀重新负荷组患者主要终点发生率为3.7%，安慰剂组为9.4%（p = 0.037）；这种差异主要是由于围手术期心肌梗死减少所致。阿托伐他汀组术后肌酸激酶-心肌带和肌钙蛋白-I升高超过正常上限的发生率较低（分别为13%对24%，p = 0.017；37%对49%，p = 0.021）。多变量分析确定阿托伐他汀重新负荷是30天主要不良心脏事件发生率降低风险的预测因素（比值比：0.50，95%置信区间：0.20至0.80；p = 0.039），主要见于急性冠状动脉综合征患者（相对风险降低82%；p = 0.027）。
ARMYDA-RECAPTURE试验表明，高剂量阿托伐他汀重新负荷可改善接受PCI的慢性他汀治疗患者的临床结局。这些发现可能支持即使在慢性治疗背景下，在干预前早期常规高剂量阿托伐他汀重新负荷的策略。
