Key result
Paclitaxel-coated balloons show no statistically significant reduction in 2-year target lesion failure vs uncoated balloons.
Why the study?
A simplified scoring system stratifies patients by restenosis risk after PCI, but its ability to identify differential treatment effects of paclitaxel-coated versus uncoated balloon angioplasty in ISR is unknown.
Does paclitaxel-coated balloon angioplasty reduce target lesion failure compared to uncoated balloon angioplasty in patients with coronary in-stent restenosis across different restenosis risk strata?
RCT (n=600)
2:1
Does paclitaxel-coated balloon angioplasty reduce target lesion failure compared to uncoated balloon angioplasty in patients with coronary in-stent restenosis across different restenosis risk strata?
Paclitaxel-coated balloon angioplasty is safe and effective for treating coronary in-stent restenosis, with consistent reductions in target lesion revascularization across different restenosis risk strata.
Supports broad paclitaxel-coated balloon use across ISR risk tiers; extends AGENT IDE primary results but subgroup analysis leaves confirmation open.
Background Insulin-dependent diabetes, small vessel size, and long lesion length are major risk factors for coronary restenosis after percutaneous coronary intervention. A simplified scoring system incorporating these factors stratifies patients by restenosis risk. Whether this scoring system identifies differential treatment effects among patients with in-stent restenosis (ISR) undergoing paclitaxel-coated vs uncoated balloon angioplasty is unknown. Methods In the AGENT IDE trial, 600 patients with coronary ISR were randomized 2:1 to paclitaxel-coated or uncoated balloon angioplasty. Patients were stratified by restenosis risk based on insulin-dependent diabetes, reference vessel diameter ≤3.0 mm, and lesion length ≥30 mm (high risk: score ≥2; intermediate/low risk: score 0-1). This subgroup analysis evaluated target lesion failure (TLF), a composite of target lesion revascularization (TLR), myocardial infarction, or cardiac death, and its individual components through 2 years. Results A total of 110 (18.3%) patients were classified as high risk and 490 (81.7%) as intermediate/low risk. At 2 years, the first TLF occurred in 29.4% and 47.0% of high-risk patients treated with paclitaxel-coated balloon vs uncoated balloon treated high-risk patients, respectively (hazard ratio [HR], 0.57; 95% CI, 0.30-1.08). Corresponding rates in intermediate/low-risk patients were 26.5% and 30.9%, respectively (HR, 0.79; 95% CI, 0.55-1.1, P Int = .37). Among high-risk patients, paclitaxel-coated balloon reduced total TLF (HR, 0.49; 95% CI, 0.26-0.92) and total TLR (HR, 0.41; 95% CI, 0.21-0.80). There was a consistent reduction in total TLR in patients with intermediate/low restenosis risk ( P Int = .31). There were no instances of definite or probable stent thrombosis in the paclitaxel-coated balloon arm. Conclusions Coronary angioplasty with paclitaxel-coated balloon was safe and effective for treating patients with coronary ISR across restenosis risk groups.
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Gaba et al. (2026) conducted an RCT in coronary in-stent restenosis (n=600). paclitaxel-coated balloon angioplasty vs. uncoated balloon angioplasty was evaluated on first target lesion failure (TLF) at 2 years in high-risk patients (HR 0.57, 95% CI 0.30-1.08). Paclitaxel-coated balloon angioplasty yielded a 2-year first target lesion failure rate of 29.4% vs 47.0% with uncoated balloons in high-risk in-stent restenosis patients (HR 0.57; 95% CI 0.30-1.08).
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