Abstract 12458: Limb and Cardiovascular Events at 6 Months Among CLTI Patients Receiving Routine Care at BEST-CLI Sites: An Interim Report From the BEST-Registry
Weissler, H; Patel, MR; Shah, N; Patterson, A; Rymer, JA; MENARD, M; Drew, LA; Mark, DB; Mena-Hurtado, C; Brooke, B; Molnar, R; Zayed, M ...
Published in: Circulation
Chronic limb-threatening ischemia (CLTI) affects 1-2 million Americans yet remains understudied. Existing CLTI trials focus on endovascular procedures and surgeries, maintain strict inclusion criteria, and may not fully capture the breadth of the CLTI population. We aimed to build a robust understanding of current treatments, outcomes, quality of life, and healthcare utilization among a diverse cohort of CLTI patients from across the United States.
Designed as a companion to the BEST-CLI randomized trial, the BEST-Registry will prospectively enroll >1,000 CLTI patients at 40 U.S. BEST-CLI sites and follow their clinical courses for 12 months. Though initially, only patients ineligible for BEST-CLI were to be enrolled, BEST-Registry enrollment did not begin until after BEST-CLI enrollment ended. Baseline data including demographics, medications, and available hemodynamic data are collected as well as wound care regimens, interventions, and quality of life (VASCUQOL-6, EQ-5D, and SF-12). The primary adjudicated endpoint is major adverse limb events (MALE) defined as above-ankle amputation or major revascularization. Secondary endpoints include mortality, hospitalizations, MALE-free survival, and quality of life.
We will present 6-month adjudicated outcomes of 534 participants. The median age is 70.0 years [IQR 62.0, 77.0] and 35% are female (
). Documented rates of hypertension (89%), diabetes (67%) and hyperlipidemia (78%) are high at baseline. Only 46.6% of patients had hemoglobin A1c and 38.8% LDL-c lab values available within a year. However, control of these two lab values was relatively good (
).
Patients with CLTI enrolled in the BEST-Registry are diverse, have complex disease, many comorbidities, and receive a variety of treatments. Registry data at 6 and 12 months will provide important context for the BEST-CLI trial results and characterize contemporary management and outcomes in CLTI.
