LIFE-BTK Outcomes Analyzed Using GLASS Classifications

November 5, 2024—Investigators from the LIFE-BTK randomized controlled trial evaluating the use of the Drug-Eluting Resorbable Scaffold (Abbott) shared a new analysis from the trial looking at its outcomes using the Global Limb Anatomic Staging System (GLASS). The data were presented by Brian G. DeRubertis, MD, during a 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.

LIFE-BTK enrolled 261 patients randomized 2:1 to receive either the Esprit BTK or percutaneous transluminal angioplasty. Its primary efficacy endpoint was the composite of freedom from above-ankle amputation, target vessel occlusion, target lesion binary restenosis, and clinically driven target lesion revascularization at 1 year. According to the analysis presented at VIVA, freedom from events occurred in 72.1% of patients GLASS stage I, compared to 53.3% in GLASS II to III. Dr. DeRubertis noted that this 18.78% difference was statistically significant (P = .0068).

Freedom from target vessel occlusion and binary restenosis were also consistent with the primary endpoint, favoring the GLASS stage I group.

As summarized in a VIVA announcement, Dr. DeRubertis concluded that in this analysis, the GLASS system effectively identified patients at higher risk for adverse clinical events, and that the use of Esprit BTK in patients with chronic limb-threatening ischemia showed consistent results irrespective of GLASS staging.