Debate over sirolimus versus paclitaxel drug-coated balloons (DCBs) in the femoropopliteal segment is shifting from adoption toward optimal use, as new data and expert discussion underscore the need to define best-case scenarios for each.
In a 2026 Charing Cross (CX) Symposium (21–23 April, London, UK) session that combined podium-first presentations with debate, subsequent audience polling revealed an even split over the routine use of sirolimus in chronic limb-threatening ischaemia (CLTI) patients; 47% of attendees voted in favour of the routine use of sirolimus DCBs in the femoropopliteal segment—at least in CLTI patients— to just 38% against, with 15% of attendees undecided. This result was reflected by the panel who broadly agreed that the question should no longer be “if” sirolimus should be used, but when and where.
The debate focused on whether there is currently sufficient evidence to support the routine use of sirolimus DCBs in femoropopliteal intervention, particularly in patients with CLTI. Speaking for the motion, Raghuram Lakshminarayan (Hull, UK) argued that with the advent of second-generation DCBs, sirolimus should be considered a viable alternative to paclitaxel.
Referencing three-year results from the SIRONA trial, he highlighted signals of superiority in the femoropopliteal segment and pointed to the mechanistic profile of sirolimus, including inhibition of smooth muscle cell proliferation and migration, alongside anti-inflammatory and immunomodulatory effects. “In a one-to-one randomised, non-inferior setting with durable results, we choose therapy with more control, a wider therapeutic window and a better long-term trajectory,” he said. Addressing the lack of guideline inclusion, Lakshminarayan added that “absence of endorsement is not absence of evidence”.
He went on to acknowledge that evidence in CLTI is less mature than in the claudication population but noted that this is parallel to the evolution of other technologies such as intravascular lithotripsy and atherectomy.
Finalising his statements, Lakshminarayan stated that the current level- one evidence and “strong mechanistic profile” for sirolimus use in a CLTI popu – lation is enough to justify its routine use. Yet, “routine use does not mean exclusive use,” he added, “but whenever you consider a DCB, you should consider a sirolimus DCB. The case is not just adequate, it is overdue.”
Arguing against the motion, Thomas Zeller (Bad Krozingen, Germany) emphasised the limited evidence base for both drug classes in CLTI. His argument focused on questioning the routine appli – cation of sirolimus in this subgroup but largely supported maintaining the position of paclitaxel DCBs among viable treatment options.
Zeller pointed to longstanding data in support of paclitaxel, including real-world CLTI outcomes, which demonstrated sustained freedom from reintervention and amputation, as well as randomised controlled trials below the knee.
He also defended paclitaxel’s mechanism of action, describing its benefit in inflammatory and proliferative phases of restenosis. “Safety has been questioned, but safety in local drug delivery is a matter of dose,” stated Zeller.
“On a balloon, dose is not high enough to cause significant vessel injury. Paclitaxel DCBs have proven efficacy above and below the knee, with clinical experience of more than 25 years,” Zeller asserted. In his closing arguments, he reiterated that sirolimus is “promising” but added that evidence for any DCB in a CLTI population remains “sparse”.
Hany Zayed (London, UK), sparking discussion from the floor, queried whether the debate is asking the correct question; rather than asking whether sirolimus or paclitaxel is superior, should which drug is best suited to which clinical scenarios be defined—such as CLTI versus claudication, or chronic total occlusions (CTOs) versus stenotic lesions.
This then initiated discussion among panellists on the heterogeneity of the available data, or the present “potpourri of variables” as Koen Deloose (Dendermonde, Belgium) coined. With trials that entangle CLTI and claudicants in parallel, as well as above- and below-the-knee indications, panellists and audience members alike called for clearly defined, head-to-head randomised trials without a class-effect. Panellist Brian DeRubertis (New York, USA) echoed this sentiment, stating that, while paclitaxel DCBs have been “wildly successful” above the knee, outcomes below the knee have not been, calling appropriate drug selection for this indication into question.
During this session, multiple podium-first presentations contributed late-breaking data to the discussion. First, Yann Gouëffic (Paris, France) reported one-year data from the IN.PACT Admiral paclitaxel DCB (Medtronic) registry in patients with CLTI.
The trial enrolled 200 patients, 179 of whom completed 12-month follow-up. Patients had an average age of 69.4 years, 34% were female and 41.5% had diabetes type 1 or 2. Gouëffic stated that, of the initial cohort, 56% of patients had claudication and 23.5% presented with CLTI. He described that 35.8% of enrolees had moderate to severe calcification while 46.9% had an occluded lesion. Pre-dilatation was required in 70.5% of cases and was more common in occlusions (82.5%). The speaker also noted that ancil – lary treatment, which most commonly included atherectomy or a specialty balloon, was required in 31.6% and 26.3% of cases, respectively.
Of their results, Gouëffic reported 96.3% freedom from all-cause mortality, 97.2% freedom from clinically driven target lesion revascularisation (CD-TLR) and improved symptoms in 94.9% of patients at 12 months, with 52.5% of patients symptom free at follow-up.
Later, Ulf Teichgräber (Jena, Germany) reported three-year results from the SIRONA randomised controlled trial comparing the MagicTouch (Concept Medical) sirolimus-coated balloon and paclitaxel DCB angioplasty in the femoropopliteal segment. Teichgräber stated that, having reached their primary endpoint at one year, which showed non-inferiority of the sirolimus DCB, they now wanted to ask: “Do our long-term results really confirm these initial positive findings?”
Enrolling 482 patients between April 2021 and September 2022 across 25 clinical sites in Germany and Austria, the investigation focused solely on claudicants, excluding CLTI patients. Of those enrolled, 24% and 27% had a Rutherford-Becker classification of two and 73% and 69% of three in the sirolimus and paclitaxel cohorts, respectively.
At three years Teichgräber reported a “very stable” trend for sirolimus, maintaining a freedom from CD-TLR rate of 88.2%, which was 91.2% at two-year follow-up. For paclitaxel, the speaker highlighted a “dramatic drop”, showing a CD-TLR rate of 80.2% at three-year follow-up, compared to 88.1% at two years.
Concerning freedom from amputation, the speaker noted an identical rate of 99.6%—“this is what we expected, as we are looking at claudicants and not CLTI”, Teichgräber said. Additionally, the speaker noted that all-cause mortality and walking distance did not differ between groups at latest follow-up.
Following this, Michael Lichtenberg (Arnsberg, Germany) presented the 24-month results from the SUCCESS PTA registry study examining the SELUTION SLR drug-eluting balloon (DEB; Cordis) in a real-world population of peripheral arterial disease (PAD) patients. The multicentre regis – try enrolled 723 patients across 27 sites in eight countries. At 24 months, follow-up was available for 585 patients, representing 81.3% of the initial cohort.
Designed as an all-comers registry, the study included both claudicants and those with CLTI, a population in which diabetes mellitus and renal failure were prominent. Complex lesion profiles were also common in this cohort, the speaker noted, with a mean lesion length of 128mm and total occlusions present in 42.1% of cases.
At 24 months, freedom from CD-TLR using a Kaplan-Meier curve was 86.1%, compared to 91.4% at 12 months, suggesting “sustained efficacy of this drug and balloon technology in a very complex lesion and patient board”, said Lichtenberg.
Rates of major adverse clinical events remained low, with one major amputation reported in the claudicants group, attributed to sepsis rather than PAD. In the CLTI cohort, eight major target limb amputations were recorded; all-cause mortality at 24 months was 7.8%, the speaker reported.
