Abstract 8517: Randomized Double-Blind Placebo-Controlled Pilot Study of Ranolazine Before Elective Percutaneous Coronary Intervention
Introduction. Ranolazine is a novel antianginal drug that reduces intracellular sodium and calcium accumulation during ischemia thus limiting ischemic injury. It remains unknown, however, if the drug can play a role in the pathophysiology of small myocardial infarctions after percutaneous coronary intervention (PCI).
Hypothesis. Aim of this study was to verify in a randomized study if pre-treatment with ranolazine before PCI has any protective effect.
Methods. Fifty patients with stable angina (32 men, age: 55+13 years) scheduled for elective coronary intervention entered a randomized, double-blind, placebo-controlled pilot trial. For 7 days prior to the procedure, 25 patients were assigned to receive ranolazine (500 mg twice daily) and 25 patients had placebo. Creatine kinase-MB, troponin-I and myoglobin levels were measured at baseline and at 8 and 24 hours post procedure.
Results. Comparison between the two groups did not show any difference in age, sex, risk factors, cardiac function, and extension of coronary artery disease. Also, there was no difference in any technical aspect of PCI. Detection of markers of myocardial injury above the upper normal limit was significantly lower in the ranolazine vs placebo group: 12% vs 35% for creatine kinase-MB (p=0.001), 20% vs 48% for troponin-I (p=0.0004) and 22% vs 51% for myoglobin (p=0.0005). Myocardial infarction by creatine kinase-MB determination was less commonly seen after PCI in the ranolazine than in the placebo-group (5% vs 18%, p=0.025). Postprocedural peak levels of creatine kinase-MB (2.9+18 vs 7.5+18 ng/mL, p=0.0002) were also significantly lower in the ranolazine vs placebo group. No significant side effect was reported by the two groups of patients.
Conclusions. Pretreatment with ranolazine 500 mg twice daily for 7 days significantly reduced procedural myocardial injury in elective PCI. These findings indicate that ranolazine may provide a friendly protection to ischemic cardiomyocytes. A multicentre randomized study is now ongoing and complete results will be available by 2012.
- © 2011 by American Heart Association, Inc.