Factors Associated with Lower Preoperative Quality of Life in Patients with Chronic Limb Threatening Ischemia in the BEST-CLI Trial

J Vasc Surg. 2022 Jun 14;S0741-5214(22)01649-4. doi: 10.1016/j.jvs.2022.06.004. Online ahead of print.


Objectives: There is limited contemporary data regarding health-related quality of life (HRQOL) measures in patients with chronic limb-threatening ischemia (CLI).

Methods: The Best Endovascular versus Best Surgical Therapy in Patients with CLI (BEST-CLI) trial is an ongoing, NIH-sponsored, multicenter, randomized controlled trial comparing revascularization strategies in patients with CLI. BEST-CLI baseline HRQOL measures were evaluated for patient-specific variables that were associated with poor HRQOL and then compared with published outcomes. The HRQOL measures VascQOL (Vascular Quality of Life Questionnaire), EQ-5D (EuroHRQOL 5D), and SF-12 Index, physical component (PCS) and mental component (MCS) scores were aggregated from preoperative questionnaires completed by trial subjects at baseline visits. Multivariable linear regression models were fit to determine which baseline characteristics were associated with poor HRQOL.

Results: 1830 subjects were randomized into BEST-CLI. The majority (94.9%, 95.8%, and 95.8%) completed the VascQOL, EQ5D, and SF-12 instruments at baseline. In VascQOL, female sex, smoking history, opioid use, and non-independent ambulation predicted lower HRQOL scores. Overall, VascuQOL scores were similar to those of participants in the Bypass versus Angioplasty in Severe Ischemia of the Leg (BASIL) [(3.07(1.2)) vs 2.9(1.1)), P=.07]. In EQ5D, non-independent ambulation predicted lower HRQOL scores. In SF-12, female sex, opioid use, non-independent ambulation and history of smoking predicted lower HRQOL scores. The mean (standard deviation) SF-12 PCS for all patients in the study was 33.0(8.5) and for MCS was 46.4(12.0), significantly lower than the national SF-12 scores for US population over 60 years of age which is PCS of 46.5(11.4) and MCS of 52.9 (8.7).

Conclusions: Patients with CLI entering the BEST-CLI trial have very low HRQOL scores comparable to patients suffering from other chronic conditions characterized by physical limitation and chronic pain. A history of smoking, impaired ambulation, opioid use, and female sex predicted lower HRQOL in CLI patients, using multiple HRQOL measurement tools.