Presented today, late-breaking data from the second year of the LIFE-BTK clinical trial demonstrate the long-term effectiveness of the US Food and Drug Administration (FDA)-approved Esprit BTK everolimus-eluting resorbable scaffold system (Abbott Vascular) in patients with the most severe form of below-the-knee (BTK) peripheral arterial disease (PAD). The data show that the Esprit BTK offers sustained benefits over balloon angioplasty with fewer repeat procedures at two years.
The LIFE-BTK trial evaluated the Esprit BTK in more than 260 patients worldwide with BTK PAD, comparing treatment with the Abbott device to balloon angioplasty—the current standard of care. Following the presentation of one-year results at TCT 2023 (23–26 October, San Francisco, USA), two-year results were revealed during a late-breaking data session at VIVA 2024 (3–6 November, Las Vegas, USA).
“PAD is a dangerous condition that is complex to treat, with limited approved treatment options,” said Brian DeRubertis (New York Presbyterian–Weill Cornell Medical Center, New York, USA), presenter and one of the principal investigators for the trial, in a press release announcing the results. “Abbott’s Esprit BTK system offers a new option for treating people with the most severe forms of PAD, helping to heal blood flow and potentially salvage limbs.”
Results after two years of the LIFE-BTK clinical trial showed that 90.3% of patients in the Esprit BTK arm did not require a reintervention at 24 months. The trial also showed sustained efficacy at 24 months.
Furthermore, compared to balloon angioplasty, patients treated with Esprit BTK had significantly greater freedom from chronic limb-threatening ischaemia (CLTI), at 61.5% vs. 32.8%.
Additionally, at one year, the trial’s powered secondary endpoints revealed that Esprit BTK had a higher rate of reducing vessel re-narrowing (35.2% improvement) compared to balloon angioplasty.
Alongside the announcement of these results, Abbott also shared that it has launched the Esprit BTK post-approval study (PAS) to assess the continued safety and effectiveness of Esprit BTK in treating CLTI patients in a real-world setting. The first patient was enrolled by Bernardino L Rocha (SSM Health Heart & Vascular Care, Oklahoma City, USA).
