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. 2024 Mar 26;331(12):1015-1024.
doi: 10.1001/jama.2024.1361.

Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis: The AGENT IDE Randomized Clinical Trial

Robert W Yeh  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 , Frank J Zidar  14 , Steven P Marso  15 , Jennifer A Tremmel  16 , Cindy Grines  17 , Mustafa I Ahmed  18 , Azeem Latib  19 , Behnam Tehrani  20 , J Dawn Abbott  21 , Wayne Batchelor  20 , Paul Underwood  22 , Dominic J Allocco  22 , Ajay J Kirtane  3 ; AGENT IDE Investigators
Collaborators, Affiliations

Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis: The AGENT IDE Randomized Clinical Trial

Robert W Yeh et al. JAMA. .

Abstract

Importance: Drug-coated balloons offer a potentially beneficial treatment strategy for the management of coronary in-stent restenosis. However, none have been previously evaluated or approved for use in coronary circulation in the United States.

Objective: To evaluate whether a paclitaxel-coated balloon is superior to an uncoated balloon in patients with in-stent restenosis undergoing percutaneous coronary intervention.

Design, setting, and participants: AGENT IDE, a multicenter randomized clinical trial, enrolled 600 patients with in-stent restenosis (lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm) at 40 centers across the United States between May 2021 and August 2022. One-year clinical follow-up was completed on October 2, 2023.

Interventions: Participants were randomized in a 2:1 allocation to undergo treatment with a paclitaxel-coated (n = 406) or an uncoated (n = 194) balloon.

Main outcomes and measures: The primary end point of 1-year target lesion failure-defined as the composite of ischemia-driven target lesion revascularization, target vessel-related myocardial infarction, or cardiac death-was tested for superiority.

Results: Among 600 randomized patients (mean age, 68 years; 157 females [26.2%]; 42 Black [7%], 35 Hispanic [6%] individuals), 574 (95.7%) completed 1-year follow-up. The primary end point at 1 year occurred in 17.9% in the paclitaxel-coated balloon group vs 28.6% in the uncoated balloon group, meeting the criteria for superiority (hazard ratio [HR], 0.59 [95% CI, 0.42-0.84]; 2-sided P = .003). Target lesion revascularization (13.0% vs 24.7%; HR, 0.50 [95% CI, 0.34-0.74]; P = .001) and target vessel-related myocardial infarction (5.8% vs 11.1%; HR, 0.51 [95% CI, 0.28-0.92]; P = .02) occurred less frequently among patients treated with paclitaxel-coated balloon. The rate of cardiac death was 2.9% vs 1.6% (HR, 1.75 [95% CI, 0.49-6.28]; P = .38) in the coated vs uncoated balloon groups, respectively.

Conclusions and relevance: Among patients undergoing coronary angioplasty for in-stent restenosis, a paclitaxel-coated balloon was superior to an uncoated balloon with respect to the composite end point of target lesion failure. Paclitaxel-coated balloons are an effective treatment option for patients with coronary in-stent restenosis.

Trial registration: ClinicalTrials.gov Identifier: NCT04647253.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Yeh reported receiving personal fees and grants from Boston Scientific during the conduct of the study; as well as grants and personal fees from Boston Scientific, Abbott Vascular, and Medtronic and personal fees from the US Food and Drug Administration, Elixir Medical, Shockwave Medical, and Infraredx outside the submitted work. Dr Shlofmitz reported receiving personal fees from Shockwave Medical outside the submitted work. Dr Moses reported receiving nonfinancial support from Orchestra BioMed outside the submitted work. Dr Bachinsky reported serving on the advisory board and his institution receiving funds from Abbott Vascular, Bard, Metavention, Medtronic, and Boston Scientific during the conduct of the study and his institution receiving funds from Abbott Vascular, Bard, Metavention, Medtronic, and Boston Scientific outside the submitted work. Dr Dohad reported receiving personal fees from Boston Scientific during the conduct of the study; and personal fees from Abbott Vascular and Penumbra outside the submitted work. Dr Stoler reported receiving personal fees from Boston Scientific, Medtronic, and Biotronik during the conduct of the study and personal fees from Edwards Lifesciences outside the submitted work. Dr Jefferson reported receiving personal fees from Boston Scientific during the conduct of the study; and personal fees from Shockwave Medical and Medtronic outside the submitted work. Dr Bateman reported receiving personal fees from Boston Scientific and Shockwave Medical during the conduct of the study and personal fees from Boston Scientific and Shockwave Medical outside the submitted work. Dr Grantham reported receiving personal fees from Boston Scientific, Teleflex, Shockwave Medical, Asahi Intecc, and Medtronic and grants from Boston Scientific, Asahi Intecc, and Abiomed outside the submitted work. Dr Zidar reported receiving personal fees from Abbott Vascular and Medtronic outside the submitted work. Dr Tremmel reported receiving research support from Boston Scientific during the conduct of the study; and personal fees from Abbott Vascular, Shockwave Medical, Avinger, and Boston Scientific outside the submitted work. Dr Ahmed reported serving on the advisory board for Medtronic and Boston Scientific. Dr Latib reported receiving personal fees from Medtronic, Abbott, Boston Scientific, Philips, and ANT and serving as a study principal investigator for Concept Medical outside the submitted work. Dr Abbott reported receiving grants from Boston Scientific during the conduct of the study; and grants from MED Alliance and Shockwave Medical and personal fees from Penumbra, Medtronic, Abbott, and the RECORD Trial outside the submitted work. Dr Batchelor reported receiving grants from Boston Scientific (independent investigator-initiated research grant) outside the submitted work and serving as a consultant for Boston Scientific, Edwards Lifesciences, Abbott, and Medtronic. Dr Underwood reported being an employee of Boston Scientific Corp. Dr Allocco reported being a full-time employee and stockholder of Boston Scientific Corp. Dr Kirtane reported receiving grants from Boston Scientific consisting of institutional funding to Columbia University and/or Cardiovascular Research Foundation. 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. Dr Kirtane reported receiving travel expenses/meals from Boston Scientific during the conduct of the study; and institutional funding to Columbia University and/or Cardiovascular Research Foundation from Medtronic, Boston Scientific, Abbott Vascular, Amgen, CathWorks, CSI, Philips, ReCor Medical, Neurotronic, Biotronik, Chiesi, Bolt Medical, Magenta Medical, Canon, SoniVie, and Shockwave Medical. Additionally, Dr Kirtane reported receiving travel expenses and meals from Amgen, Medtronic, Biotronik, Boston Scientific, Abbott Vascular, CathWorks, Concept Medical, Edwards, CSI, Novartis, Philips, Abiomed, ReCor Medical, Chiesi, Zoll, Shockwave Medical, and Regeneron. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Enrollment, Randomization, and Follow-Up in the AGENT IDE Trial
aPatients assessed for eligibility were those with suspected in-stent restenosis who provide informed consent to participate in the trial. bPatients did not meet additional angiographic criteria listed in eTables 3 and 4 in Supplement 2. cNo additional information available.
Figure 2.
Figure 2.. One-Year Time-to-Event Curves for the Primary End Point and Individual Components
The primary end point of 1-year target lesion failure is defined as the composite occurrence of ischemia-driven target lesion revascularization, target vessel–related myocardial infarction, or cardiac death. The reported P values were obtained from Cox proportional hazard models. HR indicates hazard ratio; and MI, myocardial infarction.
Figure 3.
Figure 3.. Prespecified Subgroup Analyses of the Primary Outcome at 1 Year
Shown is the forest plot of the hazard ratio for the primary outcome of 1-year target lesion failure (composite of ischemia-driven revascularization of the target lesion, myocardial infarction related to the target vessel, or cardiac death). RVD indicates reference vessel diameter. aDiabetic subgroup includes patients with diabetes requiring medical treatment (oral or injection) for control of blood glucose levels. bNondiabetic subgroup includes patients with diabetes treated with diet only or patients without diabetes. cReference vessel diameter (RVD) is based on angiographic core laboratory data. dRefers to patients with single stent layer treatment or patients with multiple stent layer treatment. eRefers to patients with target lesion treatment only or patients with both target and nontarget lesion treatment.
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