Journal of the Society for Cardiovascular Angiography & Interventions · 2026
Efficacy and Safety of Paclitaxel-Coated Balloon Angioplasty in Patients With In-Stent Restenosis With vs Without Diabetes.
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Gaba Prakriti, Jefferson Brian K, Shlofmitz Richard, Moses Jeffrey W, Bachinsky William, Dohad Suhail, Rudick Steven, Stoler Robert, Nicholson William, Altman John, Bateman Cinthia, Krishnaswamy Amar, Cavalcante Rafael, Yeh Robert W, Kirtane Ajay J
Аннотация
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) (P i nt = .62). Paclitaxel-coated balloon angioplasty was associated with a trend toward lower rates of ischemia-driven target lesion revascularization regardless of diabetes status. There were no instances of stent thrombosis in patients undergoing paclitaxel-coated balloon angioplasty.
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.
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) (P i nt = .62). Paclitaxel-coated balloon angioplasty was associated with a trend toward lower rates of ischemia-driven target lesion revascularization regardless of diabetes status. There were no instances of stent thrombosis in patients undergoing paclitaxel-coated balloon angioplasty.
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.