Evaluation of intracoronary adenosine to prevent periprocedural myonecrosis in elective percutaneous coronary intervention (from the PREVENT-ICARUS Trial)

Abstract

Great interest has focused on pharmacotherapy to prevent periprocedural myocardial injury during elective percutaneous coronary intervention (PCI). The aim of the present trial was to investigate the benefits of preprocedural intracoronary administration of high-dose adenosine during elective PCI. This was a single-center, double-blind, randomized trial of patients undergoing elective PCI. The patients were randomized (1:1) by sealed envelops to intracoronary adenosine (120 μg for the right coronary artery and 180 μg for the left coronary artery) or placebo. The primary study end point was a periprocedural increase in troponin I >3 times the upper limit of normal. The secondary study end points were (1) the corrected Thrombolysis In Myocardial Infarction frame count; (2) troponin I release >10 times the upper limit of normal; (3) creatine kinase-MB mass release ≥3 times the upper limit of normal; and (4) the combined cumulative incidence of in-hospital death, periprocedural myocardial infarction, and in-hospital urgent target vessel revascularization. The safety end point was the occurrence of bradycardia and ventricular arrhythmias during study drug administration. From November 2009 to September 2010, we randomized 260 patients who were undergoing elective PCI to intracoronary adenosine (n = 130) or placebo (n = 130). A greater prevalence of calcified lesions was observed in the adenosine group (p = 0.002). In contrast, a greater prevalence of type C lesions (p = 0.091), chronic occlusions (p = 0.015), worse preprocedural Thrombolysis In Myocardial Infarction flow (p = 0.038), and more severely stenotic lesions (p = 0.005) were observed in the placebo group. No difference was found in the primary (67.7% vs 70%, p = 0.69) or secondary end points. No serious side effects were observed with adenosine. In conclusion, our randomized trial showed that preprocedural intracoronary administration of a single high-dose bolus of adenosine does not provide any benefit in terms of periprocedural myonecrosis in patients undergoing elective PCI.

Trial registration: ClinicalTrials.gov NCT01148147.