The impact of oral nicorandil pre-treatment on ST resolution and clinical outcome of patients with acute ST-segment elevation myocardial infarction undergoing primary coronary angioplasty: A randomized placebo controlled trial

Introduction: Literature has shown the effects of intravenous/intracoronary nicorandil on increased myocardial salvage in patients with ST-segment elevation myocardial infarction (STEMI) treated with mechanical reperfusion. However, the possible cardioprotective effect of oral nicorandil on the clinical outcome prior to primary coronary angioplasty is not well documented. Our aim was to assess the effect of oral nicorandil on primary percutaneous coronary intervention (PPCI). Methods: A total of 240 patients with acute STEMI undergoing PPCI were randomly assigned to oral nicorandil (Intervention, n=116) and placebo (Control, n=124) groups. The intervention group received 20 mg oral nicorandil at the emergency department and another 20 mg oral nicorandil in the catheterization laboratory just before the procedure. The control group received matched placebo. Our primary outcome was ST-segment resolution ≥50% one hour after primary angioplasty. Secondary outcome was in-hospital major adverse cardiovascular events (MACE), defined as a composite of death, ventricular arrhythmia, heart failure and stroke. Results: In the patients of intervention and control groups, the occurrence of ST-segment resolution ≥ 50% were 68.1% and 62.9% respectively, (P =0.27). In-hospital MACE occurred less frequently in the intervention group, compared to placebo group (11.2% vs. 22.5%, P =0.012). Conclusion: Although the administration of oral nicorandil before primary coronary angioplasty did not improve ST-segment resolution in patients with acute STEMI, its promoting effects was remarkable on in-hospital clinical outcomes. Clinical Registration: IRCT20140512017666N1