Key result
Baseline clinical factors predict ~77% of variance in 1-year health status gains after revascularization.
RCT (n=1,533)
Randomized
Yes
In patients with chronic limb threatening ischemia undergoing revascularization, those with worse baseline health status, absence of diabetes, history of claudication, and lower WIfI stage are most likely to achieve clinically meaningful health status improvements at 1 year, regardless of revascularization strategy.
Background: Understanding patient factors associated with successful clinically meaningful health status results after undergoing endovascular or surgical revascularization for chronic limb threatening ischemia (CLTI), will enable targeted allocation of care resources. We examined predictors of meaningful improvements in 1-year health status following endovascular or surgical revascularization 1 year after the procedure. Methods: We applied distribution-based (0.5 standard deviation of baseline health status scores) minimally clinically important difference (MCID) thresholds to 1-year health status change scores derived from a pooled cohort of the endovascular and surgical arms for the Best Endovascular versus Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial. The trial was conducted during 2014-2019 and enrolled patients with CLTI from 150 international sites. Patients completed the peripheral artery disease (PAD)-specific VascuQol prior randomization and 1 year following randomization. Multivariable logistic regression models (improved vs. remained the same/worsened) for 1-year VascuQol changes were constructed, including demographic and clinical factors. Cubic splines were explored for presenting baseline VascuQol health status scores. Results: A total of 1,533 patients were included, (71.9% male, mean age 66.9 ± 9.7 years). Absence of diabetes, history of claudication, and lower Wifi stage was more likely to be associated with successful health status response at 1 year (R 2 =0.77). Baseline presenting health status was associated with the odds of achieving a successful health status response, with those presenting with lower baseline scores (VascuQol score <3), having a higher odds of a successful PAD-specific health status response. Type of revascularization (endo vs. surgery) was not associated with successful health status response ( Figure ). Conclusion: Diabetes status, claudication history, and Wifi staging are important factors to evaluate when discussing the potential for a successful health status response following endovascular or surgical revascularization. Overall, those who present with more impacted health status, stand to benefit the most, regardless of revascularization type.
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Smolderen et al. (2024) conducted an RCT in Chronic limb threatening ischemia (CLTI) (n=1,533). Endovascular revascularization vs. Surgical revascularization was evaluated on Clinically meaningful improvement in 1-year health status (VascuQol change ≥0.5 SD). Absence of diabetes, history of claudication, and lower Wifi stage predicted meaningful 1-year health status improvement following revascularization (R2=0.77), regardless of revascularization type.