Paclitaxel Balloon Improves Complex Stent Care
In patients with multilayer in-stent restenosis (ISR), treatment with a paclitaxel-coated balloon reduced target lesion failure (TLF) at 1 year to 23.8% compared with 40% with an uncoated balloon. The approach showed consistent benefits in patients with multilayer and single-layer ISR, with a greater absolute reduction in risk among multilayer cases.
METHODOLOGY:
A total of 600 patients with ISR were randomized in a 2:1 ratio to receive either a paclitaxel-coated or uncoated balloon treatment at 40 clinical sites in the US.
Participants had ISR with a reference vessel diameter between 2 mm and 4 mm, and lesion length < 26 mm, with target stenosis > 50% for symptomatic or > 70% for asymptomatic cases before predilation.
Randomization was stratified by multilayer vs single-layer ISR, and by the study's enrollment center, with 258 patients (44%) presenting with multilayer ISR.
The primary endpoints was failure of the target lesion 1 year after treatment, an outcome which consisted of ischemia-driven target lesion revascularization, target vessel-related myocardial infarction, or cardiac death.
TAKEAWAY:
Among patients with multilayer ISR, failure of the target lesion was significantly less likely with a paclitaxel-coated balloon than with an uncoated device (23.8% vs 40%; hazard ratio, 0.55; 95% CI, 0.34-0.87; P = .01).
Rates of revascularization of the target lesion were lower with a paclitaxel-coated balloon in cases of multilayer ISR (17.4% vs 37.8%; P = .0003), as were rates of target vessel-related myocardial infarction (5.9% vs 17.2%; P = .005).
Patients with multilayer ISR experienced higher overall rates of TLF than those with single-layer ISR (29% vs 15.7%; P < .0001).
Six cases of stent thrombosis occurred in the multilayer ISR group treated with uncoated balloons, with no cases reported in the group who received paclitaxel-coated balloons.
IN PRACTICE:
'The treatment of multilayer ISR represents a unique clinical challenge for practicing clinicians. The incidence of recurrent ISR following PCI [percutaneous coronary intervention] is relatively high in this group of patients, and finding optimal solutions can be challenging because of the presence of multiple layers of existing stents,' the researchers wrote. 'Treatment with the paclitaxel-coated balloon led to greater absolute risk reduction in 1-year TLF among patients with multilayer ISR compared with an uncoated balloon,' they added.
'An important takeaway from this AGENT IDE subgroup analysis is the need for a lifetime management strategy in patients with ISR undergoing' PCI, Roxana Mehran, MD, of the Mount Sinai Fuster Heart Hospital, in New York City, and her colleagues, wrote in an editorial accompanying the journal article. The findings support the use of drug-coated balloons 'as a treatment option in high-risk patients with multilayer ISR, offering a chance to improve its otherwise poor prognosis. At the same time, the overall unfavorable outcomes observed in this condition highlight the importance of selecting the optimal strategy at the first ISR occurrence,' they added.
SOURCE:
This study was led by Ajay J. Kirtane, MD, SM, of Columbia University Irving Medical Center/NewYork-Presbyterian Hospital and the Cardiovascular Research Foundation in New York City. It was published online on August 11, 2025, in Journal of the American College of Cardiology.
LIMITATIONS:
According to the authors, lesion preparation in this study was relatively conservative, with specialty balloons used in < 40% of cases. The researchers noted that more aggressive, mechanism-driven lesion preparation could have potentially further optimized outcomes, particularly in patients with complex multilayer disease. Additionally, intravascular lithotripsy and stent ablation, which are potential strategies for ISR, were not explored in the study.
DISCLOSURES:
Boston Scientific Corporation provided funding for the study. Kirtane received institutional funding to Columbia University and/or Cardiovascular Research Foundation from multiple organizations including Medtronic, Boston Scientific, Abbott Vascular, Amgen, CathWorks, Concept Medical, Philips, ReCor Medical, Neurotronic, Biotronik, Chiesi, Bolt Medical, Magenta Medical, SoniVie, and Shockwave Medical. He also holds equity options in Bolt Medical and Airiver. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
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