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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Novel Approaches for Preventing or Limiting Events (Naples) II Trial

Impact of a Single High Loading Dose of Atorvastatin on Periprocedural Myocardial Infarction

Carlo Briguori, MD, PhD^_*,,_*, Gabriella Visconti, MD^_*, Amelia Focaccio, MD^_*, Bruno Golia, MD^_*, Alaide Chieffo, MD, Alfredo Castelli, MD, Marco Mussardo, MD, Matteo Montorfano, MD, Bruno Ricciardelli, MD^_* and Antonio Colombo, MD

^_* Laboratory of Interventional Cardiology and Department of Cardiology, Clinica Mediterranea, Naples, Italy
Laboratory of Interventional Cardiology, "Vita e Salute" University School of Medicine, San Raffaele Scientific Institute, Milan, Italy

Manuscript received May 18, 2009; revised manuscript received June 25, 2009, accepted July 1, 2009.

^_* Reprint requests and correspondence: Dr. Carlo Briguori, Interventional Cardiology, Clinica Mediterranea, Via Orazio, 2, I-80121, Naples, Italy (Email: carlobriguori{at}clinicamediterranea.it).

Objectives: Atorvastatin administered at least 7 days before the percutaneous coronary intervention (PCI) reduces the rate of periprocedural myocardial infarction (MI). It is unknown whether a single, high (80 mg) loading dose of atorvastatin may reduce the rate of periprocedural MI.

Background: Periprocedural MI is a prognostically important complication of PCI.

Methods: The day before the elective PCI, 668 statin-naive patients were randomly assigned to atorvastatin 80 mg (atorvastatin group; n = 338) or no statin treatment (control group; n = 330). Creatine kinase-myocardial isoenzyme (CK-MB) (upper limit of normal [ULN] 3.5 ng/ml) and cardiac troponin I (ULN 0.10 ng/ml) were assessed before and 6 and 12 h after the intervention. Periprocedural MI was defined as a CK-MB elevation >3x ULN alone or associated with chest pain or ST-segment or T-wave abnormalities.

Results: The incidence of a periprocedural MI was 9.5% in the atorvastatin group and 15.8% in the control group (odds ratio: 0.56; 95% confidence interval: 0.35 to 0.89; p = 0.014). Median CK-MB peak after PCI was 2.10 ng/ml (interquartile range 1.00 to 12.50 ng/ml) in the atorvastatin group and 3.20 ng/ml (interquartile range 1.37 to 16.07 ng/ml) in the control group (p = 0.014). The incidence of cardiac troponin I elevation >3x ULN was 26.6% in the atorvastatin group and 39.1% in the control group (odds ratio: 0.56; 95% confidence interval: 0.40 to 0.78; p < 0.001).

Conclusions: A single, high (80 mg) loading (within 24 h) dose of atorvastatin reduces the incidence of periprocedural MI in elective PCI.

Key Words: statin • angioplasty • stent • complication • myocardial infarction

Abbreviations and Acronyms   CI = confidence interval   CK-MB = creatine kinase-myocardial isoenzyme   CRP = C-reactive protein   cTnI = cardiac troponin I   MI = myocardial infarction   OR = odds ratio   PCI = percutaneous coronary intervention   ULN = upper limit of normal

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