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Randomized Controlled Trial
. 2025 Aug 19;86(7):502-511.
doi: 10.1016/j.jacc.2025.05.062.

Paclitaxel-Coated Balloon for the Treatment of Multilayer In-Stent Restenosis: AGENT IDE Subgroup Analysis

Ajay J Kirtane  1 , Richard Shlofmitz  2 , Jeffrey Moses  3 , William Bachinsky  4 , Suhail Dohad  5 , Steven Rudick  6 , Robert Stoler  7 , Brian K Jefferson  8 , William Nicholson  9 , John Altman  10 , Cinthia Bateman  11 , Amar Krishnaswamy  12 , J Aaron Grantham  13 , Francis J Zidar  14 , Jennifer A Tremmel  15 , Cindy Grines  16 , Mustafa I Ahmed  17 , Azeem Latib  18 , Behnam Tehrani  19 , J Dawn Abbott  20 , Wayne Batchelor  19 , Rafael Cavalcante  21 , Robert W Yeh  22
Affiliations
Randomized Controlled Trial

Paclitaxel-Coated Balloon for the Treatment of Multilayer In-Stent Restenosis: AGENT IDE Subgroup Analysis

Ajay J Kirtane et al. J Am Coll Cardiol. .

Abstract

Background: Patients with coronary in-stent restenosis (ISR) within multiple layers of stent pose a specific clinical challenge because of higher rates of recurrent restenosis as well as a desire to avoid an additional layer of stent. Drug-coated balloons (DCBs) provide an alternative antiproliferative therapeutic option for multilayer ISR.

Objectives: We evaluated the efficacy and safety of a low-dose paclitaxel-coated vs uncoated balloon among patients with multilayer or single-layer ISR in the AGENT IDE (A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis) trial.

Methods: AGENT IDE is a prospective, multicenter trial that randomized patients with ISR (reference vessel diameter >2.0 mm to ≤4.0 mm and lesion length <26 mm) in a 2:1 allocation to paclitaxel-coated or an uncoated balloon following successful lesion preparation. Randomization was stratified by multi- vs single-layer ISR as well as by center. The primary study endpoint was 1-year target lesion failure (TLF): composite occurrence of ischemia-driven target lesion revascularization (TLR), target vessel-related myocardial infarction (MI), or cardiac death.

Results: Of the 600 patients randomized in the trial, multilayer ISR was present in 258 (44%) patients. Patients with multilayer ISR had higher rates of TLF at 1 year compared with those with single-layer ISR (29.0% vs 15.7%, P < 0.0001). The overall study results were consistent irrespective of multilayer vs single-layer ISR (Pinteraction = 0.66). Among patients with multilayer ISR, TLF was lower with paclitaxel-coated balloon compared with an uncoated balloon (23.8% vs 40.0%; HR: 0.55; 95% CI: 0.34-0.87; P = 0.01), driven by reductions in both TLR and target vessel-related MI. Similar findings were observed among patients with single layer ISR (1-year TLF: 13.5% with paclitaxel-coated vs 20.2% with uncoated balloon; HR: 0.64; 95% CI: 0.37-1.11; P = 0.11), although absolute event rates were lower.

Conclusions: Patients with ISR of multiple stent layers had higher rates of adverse stent-related events compared with patients with single-layer ISR. Treatment with a paclitaxel-coated balloon led to greater absolute risk reduction in 1-year TLF among patients with multilayer ISR compared with an uncoated balloon. (A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis [ISR] [AGENT IDE]; NCT04647253).

Keywords: drug-coated balloon; in-stent restenosis; multilayer restenosis; target lesion revascularization; uncoated balloon.

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Conflict of interest statement

Funding Support and Author Disclosures Boston Scientific Corporation funded this project. Dr Kirtane has received institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Amgen, CathWorks, Concept Medical, Philips, ReCor Medical, Neurotronic, Biotronik, Chiesi, Bolt Medical, Magenta Medical, SoniVie, and Shockwave Medical. In addition to research grants, institutional funding includes fees paid to Columbia University and/or Cardiovascular Research Foundation for consulting and/or speaking engagements in which Dr Kirtane controlled the content. He holds equity options in Bolt Medical, Airiver; has received travel expenses and meals from Amgen, Medtronic, Biotronik, Boston Scientific, Abbott Vascular, CathWorks, Concept Medical, Novartis, Philips, Abiomed, ReCor Medical, Chiesi, Zoll, Shockwave, and Regeneron. Dr Shlofmitz has received speaker fees from Shockwave. Dr Moses holds equity in Orchestra Biomed. Dr Bachinsky has served on medical advisory boards and has received research grants and consulting fees from Abbott Vascular, BD Bard, Boston Scientific, Medtronic, and Metavention, Inc. Dr Dohad has received institutional funding from Boston Scientific, Abbott Vascular, Abiomed, CSI, Philips, Penumbra, and Recor; he has participated in medical advisory boards, speaking engagements, and consulting for Boston Scientific, Medtronic, Abbott Vascular, CSI, and Penumbra. Dr Stoler has served on medical advisory boards for Medtronic, Boston Scientific, Edwards Lifesciences, and Biotronik; has provided consulting for Medtronic, Boston Scientific, Edwards Lifesciences, and Biotronik; and has served as proctor for Medtronic, Boston Scientific, and Edwards Lifesciences. Dr Jefferson has received consulting fees from Abbott Vascular, Boston Scientific, Medtronic, Shockwave Medical, and Abiomed. Dr Nicholson has served on medical advisory board and has received educational grants and fees for proctoring and consulting from Boston Scientific, Asahi, Medtronic, and Teleflex; research grants from Philips; has served on medical advisory boards for Rampart and Avail; and has intellectual property with Teleflex. Dr Bateman has served on a medical advisory board for Boston Scientific. Dr Grantham has received institutional research grants, honoraria, travel expense reimbursement, and speaking fees from Boston Scientific. Dr Zidar has received fees for consulting from Abbott Vascular, Medtronic, and Edwards Lifesciences. Dr Tremmel has served on medical advisory boards, and has received institutional research grants, consultant and speaker fees from Boston Scientific; has received fees for consulting and medical advisory board participation from Abbott Vascular, consulting and speaker fees from Shockwave, and consulting fees from Avinger. Dr Latib has provided consulting and advisory board participation for Boston Scientific, Abbott Vascular, Medtronic, Philips, Advanced Nanotherapeutics, and Bolt Medical. Dr Abbott has provided consulting services for Abbott, Medtronic, Penumbra, Medpace Inc, and Recor and has received institutional research grants from Boston Scientific, Med Alliance, Shockwave, Microport, and Novo Nordisk. Dr Batchelor has provided consulting for Boston Scientific, Abbott Vascular, Medtronic, Idorsia, and Edwards; has received research support from Abbott Vascular and Boston Scientific; and has served on medical advisory boards for Boston Scientific and Medtronic. Dr Cavalcante is a full-time employee with equity interest in Boston Scientific. Dr Yeh has received research grants from Abbott Vascular, BD Bard, Boston Scientific, Cook Medical, Philips Medical, and Medtronic; and has provided consulting services for Abbott Vascular, Boston Scientific, CathWorks, Elixir Medical, Infraredx, Medtronic, Shockwave Medical, and Zoll. The remaining authors have no relationships relevant to the content of this paper to disclose.

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