Abbott’s Esprit BTK Scaffold Evaluated in 2-Year Data From LIFE-BTK Trial

November 4, 2024—The 2-year results from the LIFE-BTK randomized controlled trial highlighted the sustained benefits of the Esprit below-the-knee (BTK) drug-eluting resorbable scaffold (Abbott) in treating patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal lesions.

Brian DeRubertis, MD, presented the 2-year LIFE-BTK findings in the first late-breaking clinical trials session at VIVA24, the 22nd annual Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on November 3-6 in Las Vegas, Nevada.

According to the VIVA24 press release, the Esprit BTK device demonstrated superior long-term outcomes compared to percutaneous transluminal angioplasty (PTA), particularly in terms of vessel patency and limb salvage.

At 2 years, 61.5% of patients treated with Esprit BTK achieved the combined endpoint of limb salvage and primary patency compared to 32.8% in the PTA group. This marked an absolute risk difference (ARD) of 28.66% and a hazard ratio of 0.48 (P = .0004), confirming the scaffold’s superior efficacy in maintaining open arteries and preventing disease progression, noted the press release.

Additional findings summarized in the VIVA24 press release include:

• The scaffold’s biological efficacy was evident in its ability to significantly reduce binary restenosis, with rates of 35.2% for Esprit BTK versus 57.8% for PTA (ARD, -22.57%; P = .0054), ensuring continued vessel patency over time.
• The composite of freedom from major adverse limb events at 2 years and perioperative death at 30 days was comparable between the two arms, with Esprit BTK achieving a 90.4% safety rate versus a 95.9% safety rate with PTA (P = .16), demonstrating that the scaffold offers a safe alternative for infrapopliteal interventions.

The study concluded that the 2-year outcomes of the LIFE-BTK trial suggest durable performance and long-term benefits with Esprit BTK. Its ability to maintain vessel patency and reduce restenosis presents a promising treatment option for CLTI patients, with efficacy and safety outcomes that compare favorably to PTA, noted the VIVA24 press release.