A pilot randomized study of ranolazine for reduction of myocardial damage during elective percutaneous coronary intervention

Background Ranolazine is a new antianginal drug that reduces intracellular sodium and calcium accumulation during ischemia, thus potentially limiting myocardial ischemia. It remains unknown, however, if the drug can play a role in the pathophysiology of periprocedural myocardial infarction. The aim of this study was to verify in a randomized study if pretreatment with ranolazine before percutaneous coronary intervention (PCI) has any protective effect on periprocedural myocardial damage. Methods Seventy patients with stable angina (age 62 +/- 18 years, 42 men) scheduled for elective coronary intervention entered a randomized, double-blind, placebo-controlled pilot trial. For 7 days before the procedure, 35 patients were assigned to receive ranolazine (1,000 mg twice daily) and 35 patients had placebo. Creatine kinase-MB and troponin I levels were measured at baseline and at 8 and 24 hours postprocedure. Results Comparison between the 2 groups did not show any difference in clinical features, extent of coronary artery disease, and technical aspects of PCI. Periprocedural myocardial infarction (ie, postprocedural increase of creatine kinase-MB >= 3 times above the upper limit of normal) was less commonly seen after PCI in the ranolazine than in the placebo group (6% vs 22%, P = .041). Detection of markers of myocardial injury above the upper limit of normal tended to be lower in the ranolazine vs placebo group: 23% vs 40% for creatine kinase-MB (P = .192) and 31% vs 48% for troponin I (P = .223). Postprocedural peak markers levels were also significantly lower in the ranolazine vs placebo group (creatine kinase-MB: 3.1 +/- 15.0 and 7.7 +/- 19.1 ng/mL, P < .05; troponin I: 0.15 +/- 0.35 and 0.47 +/- 0.49 ng/mL, P < .05). No significant adverse effect was reported by the 2 groups of patients. Conclusions Pretreatment with ranolazine 1,000 mg twice daily for 7 days significantly reduced procedural myocardial injury in elective PCI. (Am Heart J 2012;163:1019-23.)