In Wednesday’s peripheral arterial programme, which hosted several podium-first presentations, lower limb drug-eluting technologies took centre stage—signalling a potential shift in the treatment paradigm for chronic limb-threatening ischaemia (CLTI). Investigators shared compelling new data from studies ranging from first-in-human trials to large-scale registries, which vie to redefine durability and safety, as well as cost-effectiveness, in the peripheral arterial treatment landscape.
Opening the session, Sahil Parikh (New York, United States) delivered an economic analysis of the Espirit below-theknee (BTK) drug-eluting resorbable scaffold (Abbott) in the treatment of patients with CLTI. The two-year results demonstrated superior long-term outcomes for Esprit BTK compared to percutaneous transluminal angioplasty (PTA), particularly in terms of vessel patency and limb salvage.
Parikh stated that the incremental cost-effectiveness ratio at two years was determined by the difference in total cost divided by the difference in clinically driven target lesion revascularisation (CDTLR) endpoint failure.
“Esprit BTK showed a lower adjusted event rate compared to PTA [27.5% vs. 49.4% for primary efficacy endpoint; 10.5% vs. 21.6% for CD-TLR] showing a sustained benefit,” Parikh stated. He concluded that use of the Esprit BTK device resulted in US$3,206 per primary efficacy endpoint avoided, and US$6,068 per CD-TLR avoided.
Michel Bosiers (Bern, Switzerland) shared an update on the threeyear results of the MOTIV-BTK trial. The trial sought to evaluate the Motiv (Reva Medical) bioresorbable scaffold in 58 patients, the majority with Rutherford 4 or 5 lesions, Bosiers added.
At three years, the speaker reported 99% technical success and 80% primary patency for the Motiv device, with 93% freedom from CD-TLR at three years. Limb salvage at follow-up was 95%, with a recorded 16 deaths, although Bosiers notes that these were not deviceor procedure-related.
Presenting one-year EFEMORAL I data, Andrew Holden (Auckland, New Zealand) shared that the trial has the “lowest [percent of] residual stenosis in any reported study of femoropopliteal intervention”.
EFEMORAL I is a first-in-human trial evaluating the Efemoral scaffold (Efemoral Medical) for the treatment of symptomatic peripheral arterial occlusive disease from atherosclerosis of the femoropopliteal artery across four sites in Australia and New Zealand.
Concerning maintenance of arterial patency, even after scaffold dissolution, Holden reported 100% primary patency and freedom from TLR at three years. He also highlighted sustained improvement in clinical outcome and walking tolerance at follow-up. Among other outcomes, the speaker shared a 0–15% post-procedure residual stenosis and no acute or subacute thrombosis—the lowest ever reported for a femoropopliteal trial. Meanwhile, Holden reported that the mean minimal lumen diameter of 4.74mm recorded at six months was the “highest ever reported”.
“This has potential to be a new paradigm for femoropopliteal endovascular intervention,” he added.
The peripheral arterial programme also featured a series of podiumfirst presentations that sought to demonstrate the graduation of devices past ‘proof of patency’, to evidence of their “major clinical benefit” in lower limb arterial intervention for CLTI.
Michael Lichtenberg (Arnsberg, Germany) began with the first report of the 12-month SUCCESS-PTA trial data, which evaluated the Selution SLR (Cordis) drug-eluting balloon in patients with CLTI. The trial investigators enrolled 723 patients from 27 sites across Europe, Asia, and South America.
Lichtenberg reported positive 12-month outcomes, including consistent haemodynamic, functional and clinical improvements, with 91.1% freedom from CD-TLR overall, and 90.3% for the CLTI subgroup. Among other outcomes, the speaker reported sustained improvements in ankle-brachial index (ABI), Rutherford classification, and EQ-5D from six- to 12-month follow-up.
“These data continue to demonstrate the consistency of positive results across this new technology, even for patients with severe CLTI,” said Lichtenberg, addressing CX delegates. “This, the largest study of sirolimus drug-eluting balloons in complex peripheral arterial disease patients, is proof that this technology works,” he stated.
Elsewhere in the session, Edward Choke (Georgetown, Malaysia) delivered three-year realworld outcomes from the HOPE registry, evaluating MagicTouch (Concept Medical) sirolimus-coated balloon versus plain balloon angioplasty in the belowthe- knee (BTK) subgroup.
“At three years, sirolimus-coated balloons were associated with lower BTK interventions,” Choke reported, showing a 76.5% versus 64.9% freedom from TLR for MagicTouch and plain balloon angioplasty, respectively. He added that sirolimus was superior to plain balloon angioplasty regarding amputation-free survival (AFS), showing 60.9% and 47.4% rates, respectively, in the two groups.
“Survival was somewhat surprising,” said Choke, who detailed that, at three years, sirolimus was associated with better survival, hypothesising that this was due to higher rates of reintervention in the plain balloon angioplasty group, and therefore, “in this high-risk and highly frail group of CLTI patients, any procedures done will confer a risk to life”.
Choke ended pragmatically: “This is real-world data, and there are confounders both known and unknown,” he said. “Although sirolimus was associated with better outcomes, we should wait for the final data to emerge in the next one to two years before making definitive conclusions.”
Next, DeRubertis shared 12-month amputation and readmission rates between the Eluvia (Boston Scientific) drug-eluting stent versus bare device therapies in a large contemporary real-world peripheral arterial disease (PAD) cohort.
He outlined that their evaluation was based on de-identified electronic health records (EHR) which granted his team access to data for approximately 10,000 patients. Of these, the investigators identified 881 patients treated with the Eluvia device and 5,156 treated with the non-drug-eluting device. They found that race and ethnicity distributions differed between groups, with Eluvia being more frequently used in Black and Hispanic patients.
“This is important because these two groups of patients are known to have worse outcomes in the United States in terms of amputation rates,” DeRubertis told the CX audience. Following propensity score matching to “reduce bias associated [with] device selection”, DeRubertis outlined that above-ankle amputation and any readmission within 12 months occurred “significantly more frequently” with non-drugeluting therapy versus the Eluvia drug-eluting stent.
Considering these results, DeRubertis restated the significance of reducing amputations to “not only save cost to the patient, but to the healthcare system”. Showing a decline in amputation and readmission rates, the speaker confirmed the dual benefit of the drug-eluting stent in saving limbs and reducing the economic burden that major amputation places on global healthcare.
Subsequent audience questions and panel discussion focused on differentiating characteristics of these technologies, including lesion coverage protocols and drug aggressiveness. However, when asked how interventionists decide on what device to use during daily practice, presenter Thomas Zeller (Bad Krozingen, Germany) brought the discussion back to “reality”, stating that what drives device selection in daily practice comes down to cost. “You have to take what’s on your shelf and use it,” he said. “With free choice, you can tailor these technologies to lesion characteristics.”
