EXPEDITED PUBLICATION
Efficacy of Atorvastatin Reload in Patients on Chronic Statin Therapy Undergoing Percutaneous Coronary InterventionResults of the ARMYDA-RECAPTURE (Atorvastatin for Reduction of Myocardial Damage During Angioplasty) Randomized Trial
Germano Di Sciascio, MD*,*,
Giuseppe Patti, MD*,
Vincenzo Pasceri, MD ,
Achille Gaspardone, MD ,
Giuseppe Colonna, MD and
Antonio Montinaro, MD
* Department of Cardiovascular Sciences, Campus Bio-Medico University of Rome, Rome, Italy
Interventional Cardiology Unit, San Filippo Neri Hospital of Rome, Rome, Italy
Cardiology Unit, Sant'Eugenio Hospital of Rome, Rome, Italy
Interventional Cardiology Unit, Vito Fazzi Hospital of Lecce, Lecce, Italy
Manuscript received March 13, 2009;
revised manuscript received May 1, 2009,
accepted May 4, 2009.
* Reprint requests and correspondence: Prof. Germano Di Sciascio, Department of Cardiovascular Sciences, Campus Bio-Medico University, Via Alvaro del Portillo, 200, 00128 Rome, Italy (Email: g.disciascio{at}unicampus.it).
Objectives: 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.
Background: 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.
Methods: 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).
Results: 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).
Conclusions: 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.
Key Words: coronary artery disease atorvastatin percutaneous coronary intervention myocardial infarction
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Abbreviations and Acronyms
| | ACS = acute coronary syndrome | | CK-MB = creatine kinase-myocardial band | | CRP = C-reactive protein | | MACE = major adverse cardiac events | | MI = myocardial infarction | | PCI = percutaneous coronary intervention | | ULN = upper limit of normal |
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