Coated Balloon Treatment for Complex Coronary Stent Restenosis
Coated Balloon Treatment for Complex Coronary Stent Restenosis
Source: Medscape Medical News – Journal of the American College of Cardiology
Date: August 11, 2025
1. Study Background
• In-stent restenosis (ISR) remains a difficult clinical problem after PCI.
• Two main types exist:
• Single-layer ISR = restenosis within one stent.
• Multilayer ISR = restenosis in segments treated with multiple overlapping stents, which makes treatment more complex and prognosis poorer.
• Researchers evaluated whether paclitaxel-coated balloons could improve outcomes compared with uncoated balloons, especially in multilayer ISR.
2. Methodology
• 600 patients with ISR randomized (2:1) at 40 US sites.
• Paclitaxel-coated balloon vs uncoated balloon.
• 44% had multilayer ISR.
• Primary endpoint: Target lesion failure (TLF) at 1 year (death, MI, or repeat revascularization).
3. Key Results
• Multilayer ISR:
• TLF: 23.8% (coated) vs 40% (uncoated) → HR 0.55; P = .01.
• Revascularization: 17.4% vs 37.8%; P = .0003.
• MI: 5.9% vs 17.2%; P = .005.
• Stent thrombosis: 0 vs 6 cases.
• Overall: Multilayer ISR had worse outcomes than single-layer ISR (29% vs 15.7% TLF).
4. Clinical Implications
• Paclitaxel-coated balloons reduce complications in multilayer ISR compared with uncoated balloons.
• Still, long-term prognosis remains poor, stressing the need for:
• Lifetime management strategies in ISR patients.
• Optimal first strategy at the initial ISR occurrence.
• Editorial highlights coated balloons as a valuable option in high-risk multilayer ISR patients.
Takeaway:
Paclitaxel-coated balloons significantly lower restenosis-related complications in complex multilayer ISR, offering an effective treatment alternative, though challenges in overall prognosis remain.