In Reply In the AGENT IDE trial, treatment of in-stent restenosis with a coronary paclitaxel-coated balloon significantly reduced the rate of the primary end point of 1-year target lesion failure compared with conventional balloon angioplasty. Among the components of the primary end point, target lesion revascularization was required to be adjudicated as ischemia-driven by an independent clinical events committee. Absolute rates of this end point may potentially be influenced by operator practice patterns; however, differences in rates between treatment groups are attributable to the effectiveness of the device at preventing recurrent restenosis. Importantly, the rate of target vessel–related myocardial infarction was also significantly lower in the paclitaxel-coated vs uncoated balloon group. The occurrence of this end point is neither subjective nor dependent on operator decisions.
