Abstract 4146510: Meaningful Clinical Changes Following Endovascular or Surgical Revascularization from the Patients’ Perspective: A Health Status Responder Analysis with BEST-CLI Trial Data

Background: Chronic limb threatening ischemia (CLTI) is a condition that profoundly impacts individuals’ health status. As attempts are made to improve perfusion and promote limb salvage, the overall goal of CLTI disease management is also to make people feel better as reflected by their health status (symptoms, functioning, quality of life) evaluations. It is unknown how many individuals with CLTI rate their health status as meaningfully changed following endovascular or surgical revascularization 1 year after the procedure. Methods: Secondary data analyses as a pooled cohort of the endovascular and surgical arms for the Best Endovascular versus Best Surgical Therapy in Patients with CLI (BEST-CLI) trial was conducted. Patients were recruited from 150 international sites, during 2014-2019 and completed the generic Short Form-12, EQ-5D, and the peripheral artery disease (PAD)-specific Vascuqol prior randomization and at 1 year following randomization. Using distribution-based thresholds (0.5 standard deviation of baseline health status scores) for determining a minimally clinically important difference, a descriptive analysis was performed to rate 1-year health status responses as improved, remained the same, or worsened. Results: A total of 1,533 patients were included, (71.9% male, mean age 66.9 ± 9.7 years). For patients’ overall physical health status (SF-12 PCS, EQ-5D Index), between 50.1-57.9% rated themselves as improved. For overall mental status (SF-12 MCS), only 39.1-44.8% rated themselves as improved. MCID improvement rates for generic health status did not differ by treatment arm (P-values >.05). When looking at PAD-specific health status, 76.2-76.8% made clinically relevant improvements (endo vs. surgical, P-value 0.823) ( Figure ). Conclusion: The majority of individuals with CLTI achieve clinically meaningful PAD-specific health status improvements at 1 year, regardless of type of revascularization strategy. When it relates to their overall health status, less than ½ experience improvements, especially for their mental health status, 1 in 5 actually experiences worsening. Health status rehabilitation goals following CLTI revascularization may need to be broadened to not only include lower-limb related health status, but also aim to improve overall health status with integrated disease management approaches.