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 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.
Department of Heart and Great Vessels Attilio Reale, La Sapienza University, Rome, Italy. f.pelliccia@mclink.it
Francesco
F
Pelliccia
Vincenzo
V
Pasceri
Giuseppe
G
Marazzi
Giuseppe
G
Rosano
Cesare
C
Greco
Carlo
C
Gaudio
D000083:Acetanilides / Q000008:administration & dosage / Q000627:therapeutic use*; D000368:Aged; D000787:Angina Pectoris / Q000188:drug therapy*; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D015415:Biomarkers / Q000097:blood*; D017023:Coronary Angiography; D052279:Creatine Kinase, MB Form / Q000097:blood; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009206:Myocardium / Q000473:pathology*; D010865:Pilot Projects; D010879:Piperazines / Q000008:administration & dosage / Q000627:therapeutic use*; D000069458:Ranolazine; D019210:Troponin I / Q000097:blood
D000083:Acetanilides; D015415:Biomarkers; D010879:Piperazines; D019210:Troponin I; D000069458:Ranolazine; D052279:Creatine Kinase, MB Form