Coronary disease & ACSCohort study
Use of Paclitaxel-Coated Balloons in the United States: Early Results From the AGENT Postapproval Study
- Registry study
- American College of Cardiology National Cardiovascular Disease Registry CathPCI Registry
Authors' conclusion
Real-world DCB use is increasing rapidly in the United States, driven by use in ISR lesions but also with growth among non-ISR lesions.
Study context
- Population
- Patients who underwent percutaneous coronary intervention between April 2024 and June 2025 and received drug-coated balloon (DCB), drug-eluting stent (DES), or plain old balloon angioplastypatients receiving 14,946 DCBs across 704 CathPCI Registry sites
- Participants
- 12,337 patients
- Exposure
- patients who received DCB versus alternative treatments
Main finding
As reported in the abstract
Monthly rate of DCB use for ISR percutaneous coronary intervention · study period
grew from
<1% to 17.5%
Observational data: associations, not effects.
Further findings
Use of specialty balloons
Use of intravascular imaging
Use of atherectomy
In-stent restenosis (ISR) procedures involving DCB
- of 96 452 ISR procedures, involved DCB
- 9269 (9.61%)
DCB use in non-ISR percutaneous coronary interventions
- of 810 483 non-ISR PCIs, used DCB
- 3459 (0.43%)
Safety
- In-hospital outcomes among patients treated with DCB
- 0.4% · myocardial infarction · cardiogenic shock 0.7% · ischemic stroke 0.2% · died 0.9%
Unadjusted in-hospital adverse outcomes after ISR and non-ISR DCB use vs DES
- like those for DES (standard mean difference)
- <10%
- unadjusted
Original publication
Use of Paclitaxel-Coated Balloons in the United States: Early Results From the AGENT Postapproval Study. Circ Cardiovasc Interv. Published 12 May 2026. doi:10.1161/circinterventions.126.016625
Summarised from the published abstract; every number is checked against it