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

Am Heart J. 2012 Jun;163(6):1019-23. doi: 10.1016/j.ahj.2012.03.018. Epub 2012 May 21.

Abstract

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 was less common [corrected] in the ranolazine vs placebo group: 23% vs 40% for creatine kinase-MB (P = .010) and 31% vs 48% for troponin I (P = .011). [corrected] 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.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Acetanilides / administration & dosage
  • Acetanilides / therapeutic use*
  • Aged
  • Angina Pectoris / drug therapy*
  • Angioplasty, Balloon, Coronary* / adverse effects
  • Biomarkers / blood*
  • Coronary Angiography
  • Creatine Kinase, MB Form / blood
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Myocardium / pathology*
  • Pilot Projects
  • Piperazines / administration & dosage
  • Piperazines / therapeutic use*
  • Ranolazine
  • Troponin I / blood

Substances

  • Acetanilides
  • Biomarkers
  • Piperazines
  • Troponin I
  • Ranolazine
  • Creatine Kinase, MB Form