Use of paclitaxel-coated balloon (PCB) dilation is a safe and effective adjunct option for restoring airway patency in patients with granulomatosis with polyangiitis (GPA), based on new data presented at the Annual Conference of the American Association for Bronchology and Interventional Pulmonology.

PCB has emerged as a minimally invasive alternative to manage airway damage in patients with GPA, but real-world clinical data are limited, according to Tatiana A. Rojas-Zapata, MD, visiting research fellow at the Mayo Clinic in Jacksonville, Florida, and colleagues.

“Patients with GPA-associated airway stenosis frequently experience recurrent airway narrowing, often requiring repeated bronchoscopy interventions. Although adjunctive treatments such as bronchoscopy corticosteroid injections and mitomycin C are commonly used, restenosis remains a persistent challenge,” said Rojas-Zapata. “PCB dilation with sustained paclitaxel delivery may offer an alternative approach to reduce recurrence and lessen the burden of repeated procedures in this patient population,” she said.

Rojas-Zapata and colleagues reviewed data from six adults who had a GPA that resulted in subglottic, tracheal, and/or bronchial stenosis and subsequently underwent PCB between December 2024 and December 2025. The mean age of the patients was 56.33 years, 83.3% were women, and the mean BMI was 27.6. Three patients had bronchial stenosis, two had tracheal stenosis, and one had subglottic stenosis. The patients had undergone a mean of 4.65 airway procedures prior to PCB.

The mean duration of the dilation procedures was 25.5 minutes, with the PCB inflated at a median of 12 mm in diameter with a sustained inflation of 2 minutes. No procedural or delayed complications were reported. One patient required a single treatment, four required two treatments, and one underwent four treatments within a year.

An analysis of 21 pre-PCB and seven post-PCB interprocedure intervals showed no intraprocedural or delayed complications. The median interprocedure interval was 1.61 months before PCB dilation and 3.45 months during PCB treatment. No patients required additional interventions at follow-up beyond additional PCB dilation.

Expanding Applications

“The urology experience with this balloon, particularly in the ROBUST III trial, has been quite encouraging and provided a rationale for exploring its application in the airway,” said Rojas-Zapata. “We anticipated that this therapy could have a meaningful impact on recurrent airway stenosis,” she said.

“Additional benefits could include a reduction in symptom burden, lower cumulative procedural risk, and potential cost savings for both patients and healthcare systems,” she added.

“This therapeutic approach warrants further investigation to better define its mechanisms of action, optimal indications, and long-term outcomes,” said Rojas-Zapata. Use of balloon dilation in combination with airway stenting appears promising, but more guidance is needed regarding timing and treatment sequencing to optimize clinical practice, she said. The researchers also proposed that objective assessment of airway diameter changes may represent a more objective outcome measure for airway intervention that would overcome limitations associated with the traditional focus on procedural interval as the primary outcome.

“This metric has the potential to shift the current paradigm in the evaluation of airway stenosis and may provide a more standardized framework for assessing the effectiveness of therapeutic interventions,” Rojas-Zapata added.

GPA-associated tracheobronchial stenosis can be recurrent and progressive, often requiring repeated airway interventions. This study evaluates whether PCB dilation could provide a more durable treatment option for these difficult cases.

Promising, but Preliminary

“GPA-associated tracheobronchial stenosis can be recurrent and progressive, often requiring repeated airway interventions,” said Robert Maximos, MD, MBA, DAABIP, associate professor of medicine and director of interventional pulmonology and bronchoscopy at the Joe R. and Teresa Lozano Long School of Medicine at UT Health San Antonio.

“The apparent increase in time between interventions was encouraging,” said Maximos, who was not involved in the study. “However, the study does not establish that the improvement was specifically because of paclitaxel, since the comparison is with each patient’s historical pre-PCB experience and does not include a contemporaneous conventional-balloon control group,” he noted.

The findings should be considered preliminary, said Maximos. The study included only six patients, and the objective criteria used to determine when stenosis was significant enough to require dilation were unclear, he noted. Knowing whether outcomes differ between subglottic, tracheal, and bronchial disease would be useful as well, he added.

Despite these limitations, PCB dilation appears promising for recurrent GPA-associated airway stenosis and may increase the time between interventions, but larger prospective studies with standardized criteria for intervention and longer follow-up are needed, said Maximos. “Direct comparison with conventional balloon dilation would be particularly important to determine whether the paclitaxel coating provides an additional benefit beyond mechanical dilation,” he said.

The study received no external funding, and the authors had no financial conflicts of interest to disclose. Maximos had no financial conflicts to disclose.