This advertorial, sponsored by Abbott, is only available to readers in the USA.
“We now have something on label and FDA [US Food and Drug Administration] approved that we can use as a first-line therapy for tibial vessels,” Richard Pin (Southcoast Health, New Bedford, USA) tells Vascular News, designating a primary role for the Esprit BTK everolimus-eluting resorbable scaffold system (Abbott) in the treatment of below-the-knee (BTK) chronic limb-threatening ischaemia (CLTI). In this interview, Pin highlights his extensive clinical experience with Esprit BTK and shares how the device is fundamentally changing clinical practice for a challenging disease state where timely intervention is key.
Tackling tibial vessel disease
According to Pin, one of the most pressing unmet needs in the treatment of CLTI relates to tibial vessel disease. Moreover, “time is critical” in these patients, Pin says—many of whom are referred from wound care centres—to prevent tissue loss and amputation.
Esprit BTK, Pin remarks, has “helped tremendously” in the tibial vessels, offering a “new weapon in the armamentarium” and a more durable treatment option able to keep vessels patent over a longer period of time than angioplasty thanks to its radial strength and sustained everolimus elution, all while leaving nothing behind. “Often, tibial vessels are the culprit in terms of recurrent disease, recurrent wounds, and now we have a durable option to treat that,” he says.
Pin underscores that for patients with CLTI—many of whom are poor surgical candidates due to comorbidities and lack of suitable bypass conduit—balloon angioplasty alone often falls short. Esprit BTK offers a transformative alternative, Pin claims, combining recoil resistance and everolimus elution with the long-term benefits of a bioresorbable scaffold, giving physicians a more effective and durable option to restore perfusion and preserve future treatment options.
Reduced reinterventions and “extensive” clinical experience
Pin’s views on Esprit BTK rest on vast clinical experience, with his institution being part of the landmark LIFE-BTK randomised controlled trial (RCT)—for which two-year data were presented at VIVA 2024—as well as the LIFE-BTK pharmacokinetics sub-study and the device’s postapproval study (PAS). “Our experience with Esprit BTK has been pretty extensive,” he says, “despite the short time that it’s been on the market.”
Summarising some of the headline findings from the available data, Pin details a 31% superiority versus balloon angioplasty in terms of limb salvage and primary patency at one year, with sustained benefits through two years.1,2 Most importantly, he highlights a significantly reduced need for patients to return to clinic for a reintervention following treatment with the Esprit BTK, with 90.3% of Esprit BTK patients not requiring a reintervention through two years in the trial.2,3 “Those were the things that were borne out through the clinical trial, and, from an anecdotal standpoint, those are the things we see firsthand when we’ve been using Esprit BTK,” Pin says.
The main therapy available prior to Esprit BTK has been balloon angioplasty, Pin shares, highlighting several limitations to this approach in a recounting of his treatment algorithm: “We would do our angiogram and try to open up any tibial vessels with angioplasty alone, and if that didn’t give us a satisfactory result, then we were talking about doing something off label, which was putting a coronary stent into a tibial vessel to support a dissection or recoil in the vessel that wasn’t adequately treated with angioplasty alone.” However, Pin continues, a permanent metallic implant has not been rigorously studied in an RCT in the tibials, and can compromise future treatment options, affecting limb salvage and patency.
Pin emphasises the long-term advantages of Esprit BTK, noting that patients treated with the device are closely monitored both at his centre and at wound care facilities. He details that this integrated follow-up approach—combining regular wound assessments with ultrasound and ankle brachial index (ABI) surveillance within the first one to three month—enables early monitoring and supports optimal healing. In addition, Pin remarks that the structured, ongoing follow-up every three to four months until wound resolution reflects the confidence clinicians have in Esprit BTK’s ability to promote durable vessel patency and sustained wound improvement, far beyond what balloon angioplasty alone can offer.
Pin is confident the device will continue to bring about positive long-term results, with three-year data from the LIFE-BTK trial to be released this autumn.
Key features: A first-of-its- kind device
Pin underlines several unique features of the Esprit BTK that he sees as crucial to its success so far. He highlights, for example, the fact that it is the first device of its kind to be approved by the FDA for treatment of the tibial vessels and uniquely can address both the mechanical and biological needs to effectively treat CLTI.
Pin reiterates that the scaffold provides the support to treat recoil or dissection from balloon angioplasty, with radial strength equivalent to a metallic stent within the first six months.4 On this point, Pin states that recoil is a significant issue when treating tibial vessels and is therefore something that must be addressed for optimal treatment: “Once you start working on tibial vessels often, you know that they’re going to recoil. It’s not a question of if, it’s when, and the scaffold really prevents that from occurring.”
Pin underlines another key feature in that the sustained three-month period of everolimus elution from Esprit BTK is able to suppress any kind of hyperplasia as well as any longer-term issues with stenosis, therefore maximising patency.1
Pin highlights one of Esprit BTK’s most transformative features in its bioresorbable scaffold that ‘leaves nothing behind’.5 Unlike permanent metallic implants, he explains, “Over the course of three years, the scaffold is going to dissolve, and so you don’t really have anything that is going to be a long-term irritant to the vessel. Or, if you want to go back and need to treat something else, there isn’t a piece of metal that may compromise, for instance, a distal bypass sometime down the road.”
Pin notes that the resorbable and novel nature of Esprit BTK resonates strongly with patients—many of whom have previously received permanent metallic stents. “They’re very interested,” he says. “A lot of these patients have had other stents put in before, and they’ve been told that these are for life. And here we are, with something that’s resorbable, it definitely piques peoples’ interest. This is really something patients find cutting edge in terms of technology.”
Reflecting on his experience with Esprit BTK, Pin emphasises the meaningful difference it has made in the lives of his patients. “Esprit BTK has truly changed outcomes for the patients I treat,” he shares, highlighting the device’s role in improving healing and preserving limbs in a population with limited alternatives. He advocates for its use as a first-line therapy, citing its unique ability to combine effective revascularisation with long-term vessel preservation—something traditional therapies often fail to deliver. For patients facing the devastating consequences of CLTI, Pin summarises, Esprit BTK offers new hope where few options exist.
References
1. Esprit™ BTK Everolimus Eluting Resorbable Scaffold System Instructions for Use (IFU). Refer to IFU for additional information.
2. DeRubertis BG et al, Two-Year Outcomes of the LIFE-BTK Randomized Controlled Trial Evaluating the Esprit™ BTK Drug-eluting Resorbable Scaffold for Treatment of Infrapopliteal Lesions, VIVA 2024.
3. Reintervention defined as CD-TLR.
4. Data on file. Testing done with XIENCE Sierra™ 3.5×38 mm at nominal.
5. Excluding platinum markers.
CLICK HERE FOR IMPORTANT SAFETY INFORMATION
