LIFE-BTK Trial Implemented Several Enrollment Initiatives to Facilitate Inclusion of Diverse Populations

November 5, 2024—In the LIFE-BTK trial, several initiatives were implemented to facilitate enrollment of diverse populations, ensuring that patients most affected by the disease were represented. Initiatives geared toward the patients and research staff at the sites included: (1) a study website providing information on clinical trials, disease state, and the LIFE-BTK trial; (2) patient and site brochures with information on disease state and the trial; (3) translation services in > 48 languages with interpreters available 24/7; (4) patient reimbursement for travel and assistance in booking airfare and hotel; and (5) option to conduct follow-up visits in the patient’s home. The primary effectiveness endpoint, as well as the two powered secondary endpoints, were evaluated based on various groupings of race and ethnicity.

Lawrence A. Garcia, MD, presented details on these initiatives in the final round of late-breaking clinical trial sessions 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.

As reported in the VIVA24 press release, LIFE-BTK enrolled a total of 261 patients in the United States, Australia, New Zealand, Taiwan, Hong Kong, and Singapore, of which 12.3% identified as Black or African American, 18% as Asian, 59% as White, and 16.5% as Hispanic. The trial met its primary effectiveness endpoint of limb salvage and primary patency at 1 year, demonstrating superiority of Esprit BTK Drug-Eluting Resorbable Scaffold (Abbott) over percutaneous transluminal angioplasty. The primary safety endpoint was also met. Analysis of the primary effectiveness endpoint in various race/ethnicity groupings showed consistent results with the overall population, with risk ratios between 0.32 and 0.62 in favor of Esprit BTK compared to a risk ratio of 0.45 in the overall population. The same trend was observed for both powered secondary endpoints, with risk ratios ranging from 0.32 to 0.68 and 0.30 to 0.72 for the first and second powered secondary endpoints, respectively.

The LIFE-BTK trial enrolled a patient population whose race distribution was comparable to Centers for Medicare & Medicaid Services patients with a diagnosis of chronic limb-threatening ischemia undergoing endovascular procedures. Primary effectiveness and powered secondary endpoint results in the various race and ethnicity subgroups analyzed were consistent with the overall population as to outcome with the Esprit BTK device. LIFE-BTK’s focus on ethnic and racial diversity was an important and successful goal.