Drug-coated balloons have become a first-line treatment for femoropopliteal lesions in patients with lower limb peripheral artery disease (LLPAD), offering improved patency compared to plain old balloon angioplasty (POBA)1. Drug-coated balloons vary in drug composition, dosage, excipients, and coating techniques, influencing drug release kinetics and transfer to the target lesion. The COMPARE trial was the first randomised study comparing the long-term outcomes of low-dose (2.0 μg/mm²) versus high-dose (3.5 μg/mm²) paclitaxel-coated balloons (PCBs) in complex femoropopliteal lesions, reflecting real-world clinical scenarios. Non-inferiority was met for both primary efficacy and safety endpoints after 1 year, and comparable treatment effects were reported after 2 years23. Given ongoing concerns about the long-term mortality signal of PCBs, follow-up was extended to 5 years4.
The COMPARE trial was an investigator-initiated, prospective, multicentre trial that enrolled patients with symptomatic LLPAD across 15 sites in Germany (ClinicalTrials.gov: NCT02701543). The study protocol, population, endpoints, and statistical analyses have been described in depth in prior publications23. Briefly, patients with symptomatic lesions (Rutherford 2-4) of the native non-stented superficial femoral and/or proximal popliteal artery with...
Sign up for free!
Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases from PCRonline.com
