Efficacy and Safety of Paclitaxel-Coated Balloon Angioplasty in Patients With In-Stent Restenosis With vs Without Diabetes.

Background: The AGENT IDE trial demonstrated superiority of a paclitaxel-coated balloon over an uncoated balloon in treating patients with coronary in-stent restenosis (ISR). Whether the efficacy and safety of paclitaxel-coated vs uncoated balloon differ based on diabetes status remains unclear. Methods: A total of 600 patients with ISR were randomized (2:1) to paclitaxel-coated or uncoated balloon. The primary end point was target lesion failure (TLF), which was defined as a composite of ischemia-driven target lesion revascularization, target vessel-related myocardial infarction (MI), or cardiac death at 1 year. In this longer-term analysis from AGENT IDE, patients with vs without diabetes were compared using time-to-first event and repeat events methods through 2 years. Results: Among the 598 patients with known diabetes status, 51% had diabetes. At 2 years, rates of target vessel-related MI were higher among patients with vs without diabetes. There were no significant differences in 2-year TLF with paclitaxel-coated vs uncoated balloon angioplasty in patients with ISR and diabetes (29.3% vs 35.9%; hazard ratio, 0.78; 95% CI, 0.51-1.19) or those without diabetes (24.2% vs. 32.2%; hazard ratio, 0.66; 95% CI, 0.42-1.04) ( Conclusions: Among patients undergoing percutaneous coronary intervention for ISR, the presence vs absence of diabetes was associated with higher rates of total target vessel-related MI and TLF. Diabetes did not appear to modify the treatment effect of paclitaxel-coated vs uncoated balloon angioplasty on TLF, with point estimates favoring treatment with paclitaxel-coated balloons over uncoated balloon angioplasty in both groups. However, these subgroup findings were underpowered.