Current State of Paclitaxel Drug-Coated Balloons and Drug-Eluting Stents
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Medical University of Graz, Austria
On Tuesday afternoon at ISET 2025, Marianne Brodmann, MD, from the Medical University of Graz, Austria, presented an in-depth review of drug-coated balloons (DCBs) and drug-eluting stents (DES) for treating peripheral arterial disease (PAD). Her discussion covered long-term efficacy data, comparisons between paclitaxel (PTX) and limus-based drug delivery devices, and the evolving role of these technologies in above-the-knee (ATK) and below-the-knee (BTK) interventions.
Dr Brodmann began her presentation discussing the role of PTX DCBs in ATK disease, emphasizing that PTX DCBs have demonstrated strong efficacy in ATK PAD based on large randomized controlled trials (RCTs) and real-world registries. Data from the IN.PACT Global study showed a consistent and sustained effect through 5 years, even in complex patient subgroups. Head-to-head non-inferiority trials such as the COMPARE trial confirmed that DCBs outperform standard percutaneous transluminal angioplasty (PTA) in reducing restenosis. The POPCORN study from Japan identified 6 risk factors for restenosis, helping to refine patient selection and post-procedure management.
Moving on to the next generation of drug delivery devices, Dr Brodmann compared PTX and sirolimus-based (limus) DCBs and the challenges in developing limus DCBs. PTX has a well-established role in DCB technology, but researchers are exploring sirolimus-based (limus) alternatives. Three key challenges in limus DCB development include drug uptake (sirolimus must penetrate arterial tissue within 30 to 180 seconds of balloon inflation); extended drug retention (requires a “time-release” mechanism to maintain therapeutic levels over time; and minimizing drug embolization (solutions are needed to prevent wash-off during balloon delivery).
Dr Brodmann then spoke about trials related to PTX and limus DCBs. PTX DCBs remain the gold standard for ATK disease, supported by robust 5-year clinical trial data. The SIRONA Trial is the first direct comparison of limus vs PTX DCBs and is the only RCT comparing a sirolimus-coated balloon against a PTX DCB in the femoropopliteal artery. Limus-based balloons such as SELUTION SLR™ are under evaluation as alternatives to PTX.
Reviewing the use of drug-eluting stents (DES) in ATK disease, Dr Brodmann explained that despite the success of DCBs, stenting remains necessary in complex ATK lesions. DES outperforms bare-metal stents (BMS), even when combined with PTX DCBs. The IMPERIAL trial demonstrated comparable 5-year safety and efficacy outcomes between Eluvia DES and Zilver PTX DES, and the Reality Trial (775 patients) confirmed that DES provides superior outcomes compared to BMS, particularly in longer lesions (30-210 mm).
The next evolution in stents is the use of dissolvable drug-eluting scaffolds (DRS), Dr Brodmann suggested. DRS technology is being explored in ATK disease, aiming to provide drug delivery without leaving a permanent implant. Early first-in-human studies in New Zealand and Australia suggest potential benefits.
In BTK disease, limus-based DCBs (SELUTION BTK) are currently enrolling in the largest BTK RCT. PTX DCBs (AcoArt/Litus RCT) are also under evaluation, with Chinese and Italian clinical trials demonstrating superior 3- and 5-year patient survival rates compared to PTA. Limus-based DES have demonstrated strong efficacy in BTK applications; the LIFE-BTK trial (261 patients with chronic limb-threatening ischemia) compared everolimus-eluting resorbable scaffolds against PTA, showing promising results for biodegradable stent technologies.
Dr. Brodmann’s presentation underscored the advancements and challenges in drug delivery devices for PAD, highlighting the need for continued innovation and comparative trials to optimize patient outcomes.
