The CLEAN trial, a large multicenter RCT, found no significant reduction in 12-month major adverse cardiovascular events (MACE) with adjunctive intravenous nicorandil in STEMI patients undergoing primary PCI.
Secondary analyses suggested nominal reductions in cardiovascular death and target-vessel revascularization, but no significant effects on myocardial infarction or heart failure hospitalization.
Smaller, exploratory studies show intracoronary or oral nicorandil improves microvascular function and reduces no-reflow, infarct size, and reperfusion arrhythmias.
Despite mechanistic promise and improvements in surrogate endpoints, consistent long-term clinical benefits remain unproven, cautioning against routine nicorandil use in all STEMI patients.
