Impact of nicorandil to prevent reperfusion injury in patients with acute myocardial infarction: Sigmart Multicenter Angioplasty Revascularization Trial (SMART).

BACKGROUND: Nicorandil in conjunction with percutaneous coronary intervention (PCI) has been reported to reduce reperfusion injury events and improve cardiac function in patients with acute myocardial infarction (AMI). This multicenter study was undertaken to determine the effectiveness and optimal administration of nicorandil in AMI patients.

METHODS AND RESULTS: Ninety-two patients with first AMI were randomly assigned to 1 of 3 groups: intracoronary administration of nicorandil (Group A), combined intravenous and intracoronary administration of nicorandil (Group B), and no nicorandil administration (Group C). The primary endpoint was a composite of the incidence of reperfusion-induced arrhythmia, chest pain, and no-reflow/slow-reflow. The secondary endpoint was the combined rate of improvement in the Thrombolysis in Myocardial Infarction frame count (cTFC) and ST resolution (STR). A significant difference was observed in the primary endpoint for Group B as compared with Group C (p<0.05). In the meantime, a significant improvement was shown in the secondary endpoint for Group B compared with Group C (p=0.04 and 0.006 for cTFC and STR, respectively).

CONCLUSIONS: Combined intravenous and intracoronary administration of nicorandil reduces reperfusion injury during PCI and improves the cTFC and STR in AMI, and appears to be preferable to intracoronary administration alone.