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Assessment of Vascular Function in Patients With Chronic Kidney Disease
Published on: June 16, 2014
Efficacy and safety of revascularization in patients with chronic limb-threatening ischemia by kidney function
Jun Young Lee1, Gomathy Parvathinathan2, Sai Liu2
1Department of Nephrology, Comprehensive Kidney Disease Research Institute, Yonsei University Wonju College of Medicine, Wonju, South Korea; Division of Nephrology, Department of Medicine, Stanford University School of Medicine, Stanford, CA.
Insights
Surgical revascularization reduced major adverse limb events (MALE) in chronic limb-threatening ischemia (CLTI) patients regardless of kidney function. However, the mortality benefit of surgery diminished with advanced chronic kidney disease (CKD).
Area of Science:
- Vascular Surgery
- Nephrology
- Clinical Trials
Background:
- Optimal revascularization strategy for chronic limb-threatening ischemia (CLTI) patients with chronic kidney disease (CKD) is unclear.
- Previous studies have not adequately assessed treatment efficacy and safety based on kidney function.
Purpose of the Study:
- To evaluate if surgical versus endovascular revascularization efficacy and safety differ by kidney function in CLTI patients.
- To analyze the impact of varying levels of kidney function on revascularization outcomes.
Main Methods:
- Post hoc secondary analysis of the BEST-CLI trial (NCT02060630) involving 1,704 CLTI patients.
- Patients stratified by baseline estimated glomerular filtration rate (eGFR): non-CKD (eGFR≥90), mild-moderate CKD (eGFR 45-89), and advanced CKD (eGFR<45 or dialysis).
- Primary outcome: composite of major adverse limb events (MALE) or death, analyzed using restricted mean time lost (RMTL) adjusted for inverse probability treatment weights.
Main Results:
- Surgical revascularization was linked to fewer MALE or death days in non-CKD and mild-moderate CKD groups, but not in advanced CKD.
- The benefit of surgery for mortality decreased with increasing CKD severity (P interaction=0.01).
- MALE rates remained consistent across CKD strata with surgery (P interaction=0.34), while cardiovascular events increased with CKD severity.
Conclusions:
- Surgical revascularization consistently reduced MALE across all CKD strata.
- The mortality benefit of surgical revascularization is attenuated in patients with advanced CKD.
- Individualized revascularization strategies based on kidney function are supported, requiring prospective validation.
Background:
The optimal revascularization strategy for patients with chronic limb-threatening ischemia (CLTI) with chronic kidney disease (CKD) remains unknown. We evaluated whether the efficacy and safety of surgical vs endovascular revascularization differ by kidney function.
Methods:
In this post hoc secondary analysis of BEST-CLI trial (NCT02060630), 1,704 patients with CLTI were stratified by baseline estimated glomerular filtration rate (eGFR, mL/min/1.73 m²): non-CKD (eGFR ≥ 90), mild-moderate CKD (eGFR 45-89), advanced CKD (eGFR < 45 or dialysis). The primary outcome was a composite of major adverse limb events (MALE) or death. We estimated the difference in restricted mean time lost (RMTL, in days) adjusted for inverse probability treatment weights.
Results:
Surgical revascularization was significantly associated with fewer days with MALE or death in non-CKD (RMTL difference: -127.8 days; 95% CI -176.1, -79.6) and mild-moderate CKD (-63.2 days; 95% CI -104.7, -21.8) but not in advanced CKD (-16.4 days; 95% CI -78.8, 46.0; P interaction = .02). This attenuation reflected a diminishing mortality benefit with more severe CKD (P interaction = .01), whereas the association with fewer days with MALE remained consistent across CKD strata (P interaction = .34). Major adverse cardiovascular events and serious adverse events were more common with more severe CKD but did not differ significantly by treatment.
Conclusions:
Surgical vs endovascular revascularization was consistently associated with fewer days with MALE across CKD strata. However, its association with mortality varied by kidney function, attenuating the overall benefit for the composite endpoint of MALE or death. These results support individualized revascularization strategies, but require prospective confirmation.
Trial Registration:
The BEST CLI trial is registered at ClinicalTrials.gov (NCT02060630).
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