RESUMEN
BACKGROUND: Elevation in cardiac enzymes after percutaneous coronary intervention (PCI) is common and is associated with adverse clinical outcomes. HYPOTHESIS: Administration of intracoronary nicardipine--a calcium channel blocker will reduce cardiac enzyme levels in patients undergoing elective PCI. METHODS: In a single center, prospective, double-blind placebo-controlled trial, 193 patients undergoing elective PCI (with or without stenting) for chronic stable angina and/or an abnormal stress test were randomized to receive 200 mcg of intracoronary nicardipine (n = 93) or saline solution (n = 100) prior to intervention. Cardiac enzyme levels were measured immediately and at 8 and 16 hours after the procedure. Major adverse clinical events (MACE) were assessed at 30 days and at 6 months. RESULTS: Incidence of periprocedural myonecrosis defined as elevation of troponin I levels > 1x the upper limit of normal was similar in both groups (placebo 15.4% vs drug 10.6%; P = 0.47). There was no significant difference in peak troponin I levels after PCI between the 2 groups (placebo 0.58 ng/mL +/- 1.08 ng/mL vs drug 0.97 ng/mL +/- 3.6 ng/mL; P = 0.35). Major adverse clinical events at 6 months were infrequent and not statistically different in the 2 groups (placebo 3.4% vs drug 1.2%; P = 0.52). Multivariate analysis revealed that pretreatment with nicardipine was not associated with reduction in the incidence of troponin I elevation (odds ratio [OR]: 0.54; 95% confidence interval [CI]: 0.18-1.6; P = 0.28). CONCLUSIONS: In low-risk patients undergoing elective PCI, intracoronary nicardipine administration did not produce a significant cardioprotective effect in reducing postprocedural cardiac enzymes leakage.