The Impact of Revascularization Strategy on Clinical Failure, Hemodynamic Failure, and Chronic Limb-Threatening Ischemia Symptoms in the BEST-CLI Trial

Sustained clinical and hemodynamic benefit following revascularization for chronic limb-threatening ischemia (CLTI) is needed to resolve symptoms and prevent limb loss. We sought to compare rates of clinical and hemodynamic failure as well as resolution of initial and prevention of recurrent CLTI following endovascular vs bypass (OPEN) revascularization in the BEST-CLI trial. As planned secondary analyses of the BEST-CLI trial, we examined the rates of (A) clinical failure (a composite of all cause death, above ankle amputation, major reintervention, and degradation of WIfI stage); (B) hemodynamic failure (a composite of above ankle amputation, major and minor reintervention to maintain index limb patency, failure to initially increase or a subsequent decrease in ankle-brachial index of 0.15 or toe-brachial index of 0.10, and radiographic evidence of treatment stenosis or occlusion); (C) time to resolution of presenting CLTI symptoms; and (D) incidence of recurrent CLTI. Time-to-event analyses were by intention-to-treat assignment in both trial cohorts (cohort 1: suitable single segment great saphenous vein, n = 1434; cohort 2: lacking suitable single segment great saphenous vein, n = 396) and multivariate stratified Cox regression models were created. In cohort 1, there was a significant difference in time to clinical failure (Figure; log-rank P < .001), hemodynamic failure (log-rank P < .001), and resolution of presenting symptoms (log-rank P = .009) in favor of OPEN. In cohort 2, there was a significantly lower rate of hemodynamic failure (log-rank P = .006) favoring OPEN, and no significant difference in time to clinical failure or resolution of presenting symptoms. Multivariate analysis revealed that assignment to OPEN was associated with significantly lower risk of clinical and hemodynamic failure in both cohorts, and a significantly higher likelihood of resolving initial and preventing recurrent CLTI symptoms in cohort 1 (Table), including after adjustment for key baseline patient covariates (end stage renal disease [ESRD], prior revascularization, smoking, diabetes, age >80, WIfI stage, tissue loss, infrapopliteal disease). Factors independently associated with clinical failure included age >80 in cohort 1 and ESRD across both cohorts. ESRD was associated with hemodynamic failure in cohort 1. Factors associated with slower resolution of presenting symptoms included diabetes in cohort 1 and WIfI stage in cohort 2. Durable clinical and hemodynamic benefit following revascularization for CLTI is important to avoid persistent and recurrent CLTI, reinterventions and limb loss. Initial treatment with open surgical bypass, particularly with available saphenous vein, is associated with improved clinical and hemodynamic outcomes and enhanced resolution of CLTI symptoms.TableIncidence of clinical failure, hemodynamic failure, resolution of initial chronic limb-threatening ischemia (CLTI), and development of recurrent CLTIParameterCohort 1Cohort 2Open, n = 603, No. (%w event)Endovascular, n = 617, No. (%w event)Hazard ratio (95% confidence interval)P valueOpen, n = 171, No. (%w event)Endovascular, n = 173, No. (%w event)Hazard ratio (95% confidence interval)P valueClinical failure303 (50.25)419 (67.91)0.65 (0.56-0.76)<.00181 (47.37)104 (60.12)0.67 (0.50-0.90).009Hemodynamic failure377 (62.52)464 (75.20)0.71 (0.62-0.82)<.001112 (65.50)130 (75.14)0.65 (0.50-0.84).001Initial CLTI resolution514 (85.24)514 (83.31)1.22 (1.08-1.38).002142 (83.04)140 (80.92)1.08 (0.84-1.38).54Recurrent CLTI253 (0.15)a323 (0.18)a0.81b (0.68-0.95).0176 (0.23)a83 (0.23)a0.91b (0.67-1.25).57a Person-years of follow-up incidence rate.bIncidence rate ratio. Open table in a new tab