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LATE-BREAKING CLINICAL TRIAL

Atorvastatin Pretreatment Improves Outcomes in Patients With Acute Coronary Syndromes Undergoing Early Percutaneous Coronary Intervention

Results of the ARMYDA-ACS Randomized Trial

Giuseppe Patti, MD, FACC^_*, Vincenzo Pasceri, MD, PhD, FACC, Giuseppe Colonna, MD, Marco Miglionico, MD^_*, Dionigi Fischetti, MD, Gennaro Sardella, MD, FACC, Antonio Montinaro, MD and Germano Di Sciascio, MD, FACC, FESC^_*,_*

^_* Department of Cardiovascular Sciences, Campus Bio-Medico University, Rome, Italy
Interventional Cardiology Unit, San Filippo Neri Hospital, Rome, Italy
Interventional Cardiology Unit, Vito Fazzi Hospital, Lecce, Italy
Department of Cardiovascular and Respiratory Sciences, La Sapienza University, Rome, Italy.

Manuscript received February 10, 2007; revised manuscript received February 23, 2007, accepted February 23, 2007.

^_* Reprint requests and correspondence: Dr. Germano Di Sciascio, Department of Cardiovascular Sciences, Campus Bio-Medico University, Via E. Longoni 83, 00155 Rome, Italy. (Email: g.disciascio{at}unicampus.it).

Objectives: This study sought to investigate potential protective effects of atorvastatin in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI).

Background: Randomized studies have shown that pretreatment with atorvastatin may reduce periprocedural myocardial infarction in patients with stable angina during elective PCI; however, this therapy has not been tested in patients with ACS.

Methods: A total of 171 patients with non–ST-segment elevation ACS were randomized to pretreatment with atorvastatin (80 mg 12 h before PCI, with a further 40-mg preprocedure dose [n = 86]) or placebo (n = 85). All patients were given a clopidogrel 600-mg loading dose. All patients received long-term atorvastatin treatment thereafter (40 mg/day). The main end point of the trial was a 30-day incidence of major adverse cardiac events (death, myocardial infarction, or unplanned revascularization).

Results: The primary end point occurred in 5% of patients in the atorvastatin arm and in 17% of those in the placebo arm (p = 0.01); this difference was mostly driven by reduction of myocardial infarction incidence (5% vs. 15%; p = 0.04). Postprocedural elevation of creatine kinase-MB and troponin-I was also significantly lower in the atorvastatin group (7% vs. 27%, p = 0.001 and 41% vs. 58%, p = 0.039, respectively). At multivariable analysis, pretreatment with atorvastatin conferred an 88% risk reduction of 30-day major adverse cardiac events (odds ratio 0.12, 95% confidence interval 0.05 to 0.50; p = 0.004).

Conclusions: The ARMYDA-ACS trial indicates that even short-term pretreatment with atorvastatin may improve outcomes in patients with ACS undergoing early invasive strategy. These findings may support routine use of high-dose statins before intervention in patients with ACS.

Abbreviations and Acronyms   CRP = C-reactive protein   MACE = major adverse cardiac event   PCI = percutaneous coronary intervention

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