Coronary In-Stent Restenosis Treated With Paclitaxel-Coated Balloon vs Uncoated Balloon

To the Editor We write to express our concern with the conclusion of the AGENT IDE (A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis) study, which reported drug-coated balloons to be superior to uncoated balloons based on a composite end point of 1-year target lesion failure—defined as the composite of ischemia-driven target lesion revascularization, target vessel–related myocardial infarction, or cardiac death. This composite end point was driven by the first 2 subjective and operator-dependent outcomes; however, the objective component, rate of cardiac death, was twice as high in the paclitaxel group as the control group, raising concerns for serious adverse events related to this coated balloon. Previous studies have raised concern about coated balloons, and their use remains controversial. A study comparing the AGENT drug-coated balloon with the older SeQuent drug-coated balloon reported a 1-year mortality rate of 3.1% and 1.7%, respectively.