Comparative real-world outcomes of Lutonix drug coated balloon: a nationwide cohort analysis

Monday, April 13, 2026

3:18 PM - 3:27 PM ET

Location: 718B

Presenting Author(s)

Constantino Pena, MD

Medical Director of Vascular Imaging, Interventional Radiologist
Miami Cardiac & Vascular Institute, United States

Author/Co-author(s)

EA

Ehrin Armstrong, MD

Interventional Cardiologist
HCA HealthOne Swedish Medical Center, United States
CB

Christopher Bush, MPH

Director Science
Aetion, a Datavant Company, United States
KM

Katherine Mues, PhD, MPH

VP Research
datavant, United States
NR

Neloufar Rahai, PhD, MPH

Associate Director
Aetion, Inc., United States
MJ

Molly Jung, PhD

Associate Director, HEOR
BD, United States
DC

Deon Chen, MS

Sr manager, HEOR
BD, United States
PS

Peter Schneider, MD

Professor Vascular Surgery
UCSF, United States
BB

Ben Barclay, MBA

Senior Director, HEOR
BD, United States
Eric Secemsky, MD, RPVI

Director of Vascular Intervention
Beth Israel Deaconess Medical Center, United States

Purpose: Drug-coated balloons (DCBs) are widely used for femoropopliteal peripheral arterial disease (PAD) to reduce restenosis and reintervention. While randomized trials have demonstrated efficacy of individual DCBs, head-to-head comparisons in contemporary real-world practice remain limited.

Materials and Methods:

The Premier Healthcare Database, a large U.S. hospital-based data set with over one billion unique inpatient and outpatient encounters was utilized to identify adults (≥21 years) treated with Lutonix™, IN.PACT™, or RANGER™ DCBs between Jan 2021 and Dec 2024. Follow-up began 60-days post-procedure to exclude staged interventions, and patients were censored if no healthcare encounter occurred within 90-days intervals. Pre-specified outcomes included target vessel revascularization (TVR: endovascular or surgical), time-to-TVR, major adverse events (MAE: major limb amputation above the ankle, acute limb ischemia or surgical bypass) and time-to-MAE. Propensity score weighting adjusted for demographic, clinical and treatment differences. Weighted Cox models estimated hazard ratios (HR) with 95% confidence intervals (CI).

Results: Weighted cohorts included 2,588 Lutonix™ vs 4,983 IN.PACT™ and 2,610 Lutonix™ vs 1,835 RANGER™. Baseline characteristics were well balanced post-weighting. Across both cohorts, median age was 69 years; ≥50% male; treated in an outpatient setting (≥70%), in urban facilities (≥87%) and ≥50% were Rutherford 1-3. There was no statistically significant difference in the weighted HR between Lutonix™ and IN.PACT™ 1.16 (95% CI: 0.88-1.54) and RANGER™ 1.18 (95% CI: 0.78-1.80). Likewise, there was no statistical difference between the weighted HR MAE between Lutonix™ and IN.PACT™ 0.92 (95% CI: 0.67-1.26) and RANGER™ 1.24 (95% CI: 0.79-1.92). Although not statistically significant, there was a longer time to TVR observed for Lutonix™ 41.96 [14.14, 88.05] days compared to IN.PACT™ 30.88 [8.32, 85.92] days, and Lutonix™ 44.08 [17.57, 94.17] days compared to 23.86 [9.46, 87.72] days for RANGER. Likewise for time-to-MAE 43.85 [23.28, 83.72] days for Lutonix™ compared to 28.45 [13.92, 79.01] days for IN.PACT™ and. 39.91 [24.01, 86.56] days for Lutonix™ compared to 28.57 [12.16, 65.53] days for RANGER™.

Conclusion: In this large, real-world cohort, Lutonix™, IN.PACT™, and RANGER™ DCBs showed similar efficacy and safety for femoropopliteal PAD, supporting the broad use of paclitaxel-coated DCBs in current practice.