Relationship between WIfI Stage and Quality of Life at the time of Revascularization in the BEST-CLI Trial
OBJECTIVES: WIfI stage measures the extent of wounds, ischemia, and foot infection in patients with chronic limb threatening ischemia (CLTI) and has been associated with risk of major amputation. Patients with CLTI have impaired health-related quality of life (HRQoL), which may be multifactorial in nature. We hypothesize that severity of limb threat (WIfI) is associated with poor QoL among patients with CLTI presenting for revascularization. METHODS: The dataset of the Best Endovascular versus Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial, a prospective randomized trial comparing open and endovascular revascularization strategies, was queried for HRQoL assessment at time of patient enrollment. HRQOL assessments included (1) Vascular Quality of Life (VascuQoL), (2) SF-12, containing (a) utility index score (SF-6D-R2) - incorporating physical, emotional, and mental wellbeing, (b) mental (MCS) and (c) physical (PCS) components, and (3) EQ-5D. Multivariable regression analysis was used to identify independent associations with baseline HRQoL assessments. RESULTS: There were 1568 patients with complete WIfI data analyzed, of which 71.5% were male. WIfI distribution was 35.5% stage 4, 29.6% stage 3, 28.6% stage 2, and 6.3% stage 1 patients. Patients presenting with WIfI stage 4, compared to stages 1-3, were more often male (74.9% vs. 69.6%), current smokers (25.4% vs. 17.6%), had end stage renal disease (13.3% vs. 8.5%), diabetes (83.6% vs. 60.2%), were not independently ambulatory (56.8% vs. 38.5%), and had higher median morbidity score (4 vs. 3) (P<.05 for all). On multivariable analysis, WIfI stage 4, compared to stages 1-3, was associated with lower SF-12 MCS (-2.43, 95% CI -3.73, -1.13, P<.001) and SF6D-R2 Utility index scores (-.02, 95% CI -.03-.001, P=.04). WIfI stage was not independently associated with baseline VascuQoL, SF-12 PCS, or EQ-5D assessment. CONCLUSIONS: WIfI stage is independently associated with poorer quality of life due to mental rather than physical health in patients with CLTI. Clinicians should be aware of the burden of mental stress borne by those with greatest limb impairment.