Initial data from the Esprit BTK post-approval study, presented at the 2026 Charing Cross (CX) Symposium (21–23 April, London, UK), revealed “promising” 30-day results, according to an Abbott press release. The data showed the company’s Esprit BTK everolimus-eluting resorbable scaffold system is a safe and effective approach in patients with very challenging chronic limb-threatening ischaemia (CLTI) and complex lesions.
The Esprit BTK post-approval study is a prospective, multicentre, single-arm, observational study assessing the long-term safety and effectiveness of the Esprit BTK system. Following the positive LIFE-BTK trial, this post-approval study monitors patients with CLTI treated with the dissolvable scaffold to prevent artery re-closure. Interim findings from this study are consistent with LIFE-BTK and support the real-world performance of the Esprit BTK scaffold.
Interim findings are consistent with outcomes from the pivotal LIFE-BTK study—previously published in the New England Journal of Medicine and presented at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) meeting (25–28 October, San Francisco, USA)—despite a range of challenging patient types that were not part of the original LIFE-BTK study, including people with end-stage renal disease and those classified as Rutherford-Becker 6.
At 30-days post treatment, the interim data from the post-approval study (n=200) demonstrated the following early results:
- All patients (100%) were free from reintervention (defined as clinically driven target lesion revascularisation).
- A high safety profile comparable to the LIFE-BTK study, with 2.6% for the composite endpoint of major adverse limb events and perioperative death, including 1% above-ankle amputation, which was not related to the device.
- Physicians successfully treated longer target lesions with an average length of 69.6±61.4mm, as reported by investigators (range: 5–400mm).
- Lesions in the LIFE-BTK trial were an average length of 52.8±41.9mm (range: 2–170 mm).
- Physicians were also able to treat more advanced calcifications with the sites reporting 39.7% of lesions were categorised as moderate and 19.2% considered severe.
- In the LIFE-BTK trial, sites categorised 27.7% of lesions to be moderate and only 3% considered severe.
“The initial 30-day results from the Esprit BTK post-approval study demonstrate how beneficial the Esprit BTK system could be to help reduce amputations and improve the lives of those most at risk,” stated Ramon Varcoe (University of New South Wales, Sydney, Australia). “We’re seeing early evidence that Esprit BTK can deliver the same robust safety and efficacy observed in LIFE-BTK, even when tackling sicker patients with longer, more complex calcified lesions. While these are still early results, it opens the possibility that the Esprit BTK system could be beneficial for those with more severe wounds, end-stage renal disease, and diverse populations who are at risk of amputation.”
