Real-world use of paclitaxel-coated balloons for in-stent restenosis grew to 17.5% of procedures, with unadjusted in-hospital adverse outcomes similar to drug-eluting stents (SMD <10%).
Observational
Yes
Does paclitaxel-coated balloon use result in similar in-hospital outcomes compared to drug-eluting stents or plain old balloon angioplasty in patients undergoing percutaneous coronary intervention?
Real-world use of paclitaxel-coated balloons in the US is rapidly increasing for both ISR and non-ISR lesions, with early in-hospital adverse outcomes similar to drug-eluting stents.
Effect estimate: Standard mean difference <10%
BACKGROUND: AGENT is the only coronary drug-coated balloon (DCB) approved for treatment of in-stent restenosis (ISR) to date. In this study, we describe trends in DCB use and compare characteristics and in-hospital outcomes between patients who received DCB versus alternative treatments. METHODS: We included patients in the American College of Cardiology National Cardiovascular Disease Registry CathPCI Registry who underwent percutaneous coronary intervention between April 2024 and June 2025 and received DCB, drug-eluting stent (DES), or plain old balloon angioplasty. Treatment groups were compared using standard mean differences. RESULTS: Between April 2024 and June 2025, 14 946 DCBs were used in 12 337 patients across 704 CathPCI Registry sites. The monthly rate of DCB use for ISR percutaneous coronary intervention grew from <1% to 17.5% during the study period. Of 96 452 ISR procedures performed overall, 9269 (9.61%) involved the use of DCB. DCB procedures were more likely to involve the use of specialty balloons (DCB 45.3% versus DES 17.5% versus plain old balloon angioplasty 28.3%), intravascular imaging (DCB 54.5% versus DES 35.1% versus plain old balloon angioplasty 30.9%), and atherectomy (DCB 14.9% versus DES 6.0% versus plain old balloon angioplasty 7.3%). Among patients treated with DCB, 0.4% experienced myocardial infarction, 0.7% developed cardiogenic shock, 0.2% had an ischemic stroke, and 0.9% died. DCB was separately used in 3459 of 810 483 (0.43%) non-ISR percutaneous coronary interventions. Unadjusted rates of in-hospital adverse outcomes after ISR and non-ISR DCB use were like those for DES (standard mean difference <10%). CONCLUSIONS: 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.
Lalani et al. (Tue,) conducted a observational in In-stent restenosis (ISR) and non-ISR lesions undergoing percutaneous coronary intervention. Paclitaxel-coated balloon (AGENT) vs. Drug-eluting stent (DES) or plain old balloon angioplasty was evaluated on In-hospital adverse outcomes (Standard mean difference <10%). Real-world use of paclitaxel-coated balloons for in-stent restenosis grew to 17.5% of procedures, with unadjusted in-hospital adverse outcomes similar to drug-eluting stents (SMD <10%).