1.2 ISR: Are DCBs Now the Answer?

Problem Presenter: Cindy Grines

These proceedings summarize the educational activity of the 18th Biennial Meeting of the International Andreas Gruentzig Society held January 27 to 30, 2026, in Puerto Ayora, Santa Cruz, Ecuador.

Faculty Disclosures     Sponsors

2026 IAGS Summary Document

Statement of problem or issue

There are several smaller clinical trials, with at least one large meta-analysis, comparing DCBs to balloon angioplasty (POBA) for ISR, and these data support DCBs as superior to uncoated balloons alone.[1] A large 600-patient randomized clinical trial, named AGENT, compared paclitaxel-coated DCBs to uncoated balloons for ISR, and found the DCB superior to POBA.[2] On the other hand, a meta-analysis of 5 RCTs (1,100 patients) comparing DCBs with drug-eluting stents (DES) for ISR, found equivalence in the two forms of treatment except there was more recurrent restenosis with DCBs, leading to higher rates of target lesion revascularization in that group.[3] The Swedish registry, SCAAR, examined this question retrospectively using their large dataset, and published a comparison that included over 10,000 coronary lesions in over 9,000 patients.[4] This analysis compared all 3 groups of treated ISR patients: POBA, DCB, and DES. The SCAAR results also showed superiority for both DCB and DES over POBA, and equivalence of DCB and DES with the exception of more target lesion revascularization with DCBs.

Gaps in current knowledge

• How should we select and prepare ISR lesions for the appropriate treatment choice?
• Does the number of layers of previous stents alter the choice of device?
• If the previous stent is under-expanded, will re-expansion alone be sufficient?
• Does vessel size and/or presence of large side branches alter device selection?

Possible solutions or future directions

The specific drug agents used on DCBs will require comparative studies. There are more data available for paclitaxel-coated DCBs, but the recently introduced sirolimus-coated DCB has shown promise for treatment of ISR.[5] The routine use of intravascular imaging (IVI) using intravascular ultrasound (IVUS) or optical coherence tomography (OCT) needs additional dedicated studies for patients with ISR. Imaging with IVUS or OCT can be useful for: (1) assessing the cause of ISR; (2) accurate sizing of the vessel; (3) determination of stent under-expansion. However, IVI remains a Class 2A recommendation in ACC/AHA/SCAI guidelines for revascularization and PCI. Since DCBs require contact time to elute and penetrate tissue at the target lesion treatment site, the optimal balloon inflation time (duration of contact) needs investigation. Preliminary data suggest shorter (median 30 sec) inflations were equivalent to longer (median 60 sec) inflations in terms of major adverse events (MACE) including target lesion revascularization.[6] However, the rates of bailout stent implantation (12.2 vs 8.8%, P=.001) and post-procedural TIMI flow <3 (4.0 vs 2.1%, P=.007) were higher with shorter compared with longer DCB inflation times. Additional studies will help confirm or refute these early findings.

References

1. Shaikh S, et al. Meta-Analysis Comparing Drug-Coated Balloon Versus Plain Old Balloon Angioplasty for In-Stent Restenosis of Coronary Arteries. Am J Cardiol. 2024 Oct 15;229:22-27. doi: 10.1016/j.amjcard.2024.07.015. Epub 2024 Jul 18. PMID: 39029724.
2. Yeh RW, et al. Paclitaxel-coated balloon vs uncoated balloon for coronary in-stent restenosis: The AGENT IDE Randomized Clinical Trial. JAMA. 2024 Mar 26;331(12):1015-1024. doi: 10.1001/jama.2024.1361. PMID: 38460161; PMCID: PMC10924708.
3. Kumar M, et al. Comparison of drug-coated balloons with drug-eluting stents in patients with in-stent restenosis: a systematic review and meta-analysis. Am J Cardiol. 2024 Sep 15;227:57-64. doi: 10.1016/j.amjcard.2024.06.028. Epub 2024 Jul 8. PMID: 38986859.
4. von Koch S, et al. Drug-coated balloons versus drug-eluting stents or plain old balloon angioplasty: a long-term in-stent restenosis study. J Am Heart Assoc. 2024 Dec 3;13(23):e036839. doi: 10.1161/JAHA.124.036839. Epub 2024 Nov 22. PMID: 39575722; PMCID: PMC11681599.
5. Cutlip DE. Randomized Trial of a Sirolimus Eluting Balloon versus Repeat Drug-Eluting Stenting or Balloon Angioplasty for Coronary In-stent Restenosis. Presented at TCT-2025. Available at: cordis.com/uploads/files/SELUTION-Clinical-Info-Files/100678148_SELUTION4ISR-TCT-HCP-Clinical-Trial-Results-Presentation_Final_2025.pdf. Accessed February 23, 2026.
6. Gurgoglione FL, et al. Angiographic and clinical impact of balloon inflation time in percutaneous coronary interventions with sirolimus-coated balloon: A subanalysis of the EASTBOURNE study. Cardiovasc Revasc Med. 2025 Apr;73:70-75. doi: 10.1016/j.carrev.2024.07.021. Epub 2024 Jul 28. PMID: 39122570.